"Low Hanging Fruit" Keeps FDA Busy & Out of Pharma's Social Media Hair

"Low Hanging Fruit" Keeps FDA Busy & Out of Pharma's Social Media Hair

Another tidbit I picked up this week at CBI's 3rd Annual Forum on Social Media Regulations and Compliance is the notion that the FDA is too busy going after the "low-hanging fruit" of promotional violations to pay much attention to violations of regulations involving social media and other esoteric Internet "tricks" such as the manipulation of meta tag data.

This came up in a discussion I started about the use of meta tags to create organic search results that are effectively branded ads lacking the FDA-required important safety information (ISI). I discussed this in previous blog posts (Who's in Charge of Your "Invisible" Metadata? WARNING: Don't Invoke the "Invisibility Rule" and Are Organic Search Results Next on FDA's Chopping Block?):

Metadata is usually "invisible" content inserted within the header of the HTML code that creates a Web page. This includes a "description" of the page or Web site and keywords. Some of this information is used by search engines to find the page and include a description of the page in the natural search result.
When you do a Google search on "Viagra," for example, you will find a "sponsored" link (i.e., paid search ad) like this:



You will also find this unpaid natural search result:



BOTH the paid ad and the search result contain content that is written and controlled by Pfizer. The natural search result content that begins with "Learn about..." is exactly the content that Pfizer included in its "description" meta tag within the HTML code for the viagra.com home page. Google just lifted that content. Users cannot control this content, only Pfizer can -- by editing the meta tag.

A medical/legal/regulatory (MLR) expert in the audience said: "The fact that the FDA may not be pressing that issue right now is because of the low-hanging fruit." He went on to further speculate that even when FDA issues its long-awaited social media guidance this practice would not be addressed because the FDA is looking at "larger organic issues."

I contend, however, that the FDA has already addressed this issue in a notice of violation (NOV) letter to Novartis regarding the use of meta data to create a "Facebook Share" social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (see Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget). Organically speaking, this seems to be equivalent to using meta data to create a search result as described above, no?

Branded Tweets Lacking ISI: What's FDA's Thinking on This?

Branded Tweets Lacking ISI: What's FDA's Thinking on This?

This week, I attended CBI's 3rd Annual Forum on Social Media Regulations and Compliance in Alexandria, VA. Many of the medical/legal/regulatory (MLR) presenters and attendees were from smaller pharma and biotech companies such as Biogen, MedImmune, Astellas, Amarin, Ferring, etc.

In the absence of specific social media guidance from the FDA, several presenters tried to "navigate through current guidance and enforcement" to offer advice on how to develop a compliant social media strategy. This technique is what is often referred to as learning from "received precedent," which is a risky methodology considering FDA's past actions that have contradicted previously-accepted precedents (see, for example, "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!" and "FDA's Actions Speak Louder than Its Words").

One topic that was discussed by at least a couple of presenters was who controls the content on social media and, specifically, what content is pharma responsible for when it engages in social media conversations.

Glenn Byrd, Senior Director, Regulatory Affairs, at MedImmune, spoke about pharma accountability in his presentation. "At what point do we lose control of our content? When do we lose the responsibility [for content] so FDA does not come after us?" He cited "retweeting" as an example. As an non-social media example, Byrd talked about B-roll video, which pharma companies often provide to TV news stations when they are doing a story about a newly released product. "They [the news outlet] take it and they do whatever they want with it," said Byrd.

Of course, the B-roll itself must be compliant with FDA regulations. If it mentions a drug name and its indication, for example, it must also provide the important safety information (ISI) just as if it were a direct-to-consumer (DTC) ad.

But pharma companies are using Twitter to tweet about brands and their indications WITHOUT including any ISI. Take for example this LYRICA tweet that @pfizer_news sent just this morning:

This links to the press release, which has all the necessary ISI. It's as if Pfizer still believes in the "one-click rule" when it comes to tweets linking to press releases. The logic is this: there is no "received precedent" of FDA citing such tweets as violative, therefore it is perfectly OK for us [Pfizer] to do this.

Note that the tweet has been "retweeted" at least 8 times and cited a "favorite" tweet at least 3 times. The tweet has also been posted to the Pharma Marketing "News From the Pharma Industry" Forum (see here) where anyone can post a "reply" message. Thus, an ongoing conversation out of Pfizer's control can result from this tweet on Twitter and on discussion boards. That is the viral nature of social media.

While Pfizer cannot be held responsible for the retweets of its branded tweet or the conversations it may start elsewhere on the Internet, it should be held responsible for the original tweet, which is similar to the search ads FDA cited as violative in 2009 (ie, lacking important safety information).

What do you think?

Pfizer's Deceptive "Campaign Against Migraine" Tweet Deleted - Too Late!

Pfizer's Deceptive "Campaign Against Migraine" Tweet Deleted - Too Late!

Sometimes, you make a mistake and want to "take it back." I understand that. But this electronically-connected world in which we live is making it much more difficult to truly delete e-mails, text messages, and tweets from the network.

Take, for example, this tweet by @Pfizer_news:

This is how the tweet looks as posted to the News Direct from the Pharma Industry Forum of Pharma Marketing Network (here), which I own and "curate"/administer.

This is how I keep up with tweets from major pharmaceutical companies: I use my forum software to automatically scan the Twitter feeds of selected pharma companies and post tweets from these Twitter accounts to the above forum. Because I am "subscribed" to this forum, I get daily email notices whenever these posts are made. That's how I learned about this tweet from @Pfizer_news.

It seems like an innocent enough Tweet and looked interesting - I wanted to see what the "campaign for migraine relief" was all about, so I clicked on the link in the tweet: http://t.co/dhp1shpv, which is Twitter-shortened link.

I was surprised when the link above took me to http://www.relpax.com/, which is the branded website for Pfizer's Relpax migraine drug. I found nothing there about the "campaign for migraine relief" as was promised by the Tweet. That's the deceptive aspect of the Tweet.

The tweet included the hashtag #CampaignAgainstMigraine. A Google search on "CampaignAgainstMigraine" leads to a real "Campaign Against Migraine" Web site sponsored by Pfizer:

NOTE: If you search on "#CampaignAgainstMigraine" you can find reference to the same tweet. The link, however, leads to http://inagist.com/, which no longer lists the tweet.

So, what's the big deal? Obviously, it is deceptive to link to a drug.com site as part of a message that implies you will be joining a campaign against a debilitating medical condition! Hopefully, grownups at Pfizer recognized this mistake and deleted the tweet. But, as I said in the beginning, the tweet lives on -- at least on the Pharma Marketing Forum mentioned above.

Followup (8 June 2012): @Pfizer_news "retweeted" with the CORRECT link this time: "Join the campaign against migraine. bit.ly/KcaV5i #CampaignAgainstMigraine" As I suspected, the link is to the site I found via Google, not to the REPLAX branded website. Hat tip to Amber Williams (@williaqj) for alerting me.

PhRMA Demands that FDA "Cabin" Its Discretion to Regulate DTC Ads

PhRMA Demands that FDA "Cabin" Its Discretion to Regulate DTC Ads

In a 20-page comment submitted to the FDA on May 14, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA), advised the FDA to "proceed cautiously and in a manner that fully protects the free speech rights of advertisers and patients" with regard to the agency's recent Draft Guidance for Industry on Direct-to-Consumer (DTC) Television Advertisements."

Recall that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement" (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

In its comments, PhRMA uses the word "cabin" as a verb, as in "clearly defined standards that cabin the reviewing official's 'unbridled discretion'" and "objective standards to cabin FDA's discretion."

Why does PhRMA want to banish FDA to a "cabin" in the woods as far it's discretion to pre-review DTC ads is concerned?

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, which is cited several times in PhRMA's comments. For example, PhRMA reminded the FDA (as if that was necessary) that the Supreme Court "recently affirmed that '[s]peech in aid of pharmaceutical marketing .... is a form of expression protected by the Free Speech Clause of the First Amendment.' Thus," says PhRMA, "when the FDA restricts the speech of pharmaceutical manufacturers and other regulated entities, the restrictions are subject to scrutiny under the First Amendment."

But the Supreme Court Court is not likely to scrutinize "informal guidance," which is not legally binding. Therefore, PhRMA is pushing the FDA to issue regulations, which carry the weight of law. "Regulations that unduly burden truthful, non-misleading commercial speech about a lawful product," says PhRMA, "hinder consumer choice ... and rarely survive constitutional scrutiny."

Of course, FDA wants to prevent "misleading" drug ads from being aired. Right now, however, it can only cite ads as "misleading" AFTER they have already been aired.

I'm not going to delve into the legal arguments that PhRMA puts forth. You can read them yourself here. I just find it interesting that the drug industry is pushing FDA to stop issuing non-binding guidances in this case as well as in the case of social media (see "WLF & Pfizer Ask Court to Block FDA Guidance on Social Media"). I also like how PhRMA uses "cabin" as a verb, hence the cabin image that accompanies this post.

Hat Tip to @AlecGaffney for alerting me to the publication of PhRMA's comments in the Federal Register, where "occasionally interesting reading [is] to be had."

Janssen to Shut Down Psoriasis 360 FaceBook Page Due to Lack of Commitment

Janssen to Shut Down Psoriasis 360 FaceBook Page Due to Lack of Commitment

Janssen Pharmaceuticals has announced it will shut down its Psoriasis 360 Facebook page, which was first launched in October, 2010. At the time, I praised this Facebook page as the "first [pharma FB site] to publish ALL comments BEFORE they are reviewed" (see "Markets as Conversations: Can You Have a Discussion with 'Psoriasis 360' on Facebook?").

Janssen cited its inability to moderate posts made to the Psoriasis 360  wall, one-third of which "mention[ed] a specific drug by name, or talk[ed] about the efficacy of a particular treatment is (or its side effects)." In such cases, Janssen had to ask for the post to be removed or to "pull" it, which I guess was too much work for them to handle after Alex Butler, former Janssen Digital Strategy and Social Media Manager, left the company. Alex was the person responsible for Psoriasis 360. For his efforts, I awarded him (not Janssen) the first ever Pharmaguy Social Media Pioneer award (see "First Pharmaguy Social Media Pioneer Award Given to Janssen's Alex Butler").

In a statement published on the Psoriasis 360 FB wall, the "Psoriasis 360 team" said "we have found ourselves removing a larger and larger proportion of posts, stifling worthwhile discussions." According a PMLiVE article, Janssen said that "within the last three months alone a third of all posts to the page had to be removed, the majority because they mentioned prescription-only medicines, but a 'significant minority' were disallowed because they included offensive language" (see here).

If one-third of the comments had to be removed or blocked, that means that two-thirds of the comments were NOT blocked. The total number of such comments I find on the Psoriasis 360 site is about 379, including 95 comments submitted by the "Psoriasis 360 team" itself. There were also several comments made by associates of Psoriasis 360 such as from "www.psoriasis360.com." That leaves 284 comments, which represents about 2/3 of the total comments Janssen had to review over the course of 18 months. Doing the math, I estimate that Janssen reviewed about 423 comments during that time for an average of 24 comments per month or less than 1 per day!

Holy cow! What a burden to bear!

What really happened was that when the social media pioneer Alex Butler left Janssen late last year, no one was left to manage the site and Janssen obviously did not feel it was worth it to devote 0.125 FTE (ie, one hour per day) to do the job or to outsource the moderation of comments.

It's obvious that Facebook did not offer Janssen a good return on investment however they may have defined that. There is still a psoriasis 360 YouTube site, which is NOT required to allow comments.

What I don't like about this is not the lack of commitment to social media conversation on Janssen's part, but using regulations as an excuse for its lack of commitment. Reviewing one comment a day is NOT a regulatory hurdle difficult to overcome. Even on sites that are not regulated -- such as this blog -- weeding out unsavory, "offensive," or spammy comments is a fact of social media life that has to be dealt with. Love it or leave it. Janssen has chosen to leave it.

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

Before I get to the "loophole," here's a summary of the guidance.

Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.

Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:

• Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
• Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
• Category 3: All TV ads for Schedule II controlled substances 
• Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
• Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision

"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA

Regarding the 45-Day Review Period, FDA says:

"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."

That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.

What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.

"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review."

After writing this, I had short Twitter conversation with Alexander Gaffney (@AlecGaffney), health wonk and writer of news for @RAPSorg & Regulatory Focus. Regarding FDA's requirement to review videos and not just storyboards, Alec said the guidance would likely cuts down on "poor marketing" spending, which I interpreted to mean "pushing the envelope" spending. In the past, pharma marketers could submit a storyboard (cheap) and run the ad without waiting for comments from the FDA. The ad could push the regulatory envelope and run its course on TV before the FDA could issue a warning letter. I commented on this previously. Read "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"

The "Loophole"
FDA does not define what exactly it means by "dissemination." Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for "pre-dissemination" review. The video can then be embedded in the drug.com website or promoted via Twitter.

The bright line between TV and online video is getting more blurry every day. I currently am able to watch Youtube videos on my TV via Apple TV. Of course, it is not the same as regular TV ads that I can skip over thanks to my new cable box that allows me to record programs and play them back later. And I may be the only person that would actively search out drug TV ads published on YouTube!

Would a pharma company want to do this? Maybe, if it does not violate the "letter" of the law; ie, is not classified as "dissemination." That would let the company off the hook for violating the law, but FDA could still cite the YouTube version as violative (ie, as it does right now). A violative YouTube version of the video could result in an FDA warning letter, which probably would be issued months after the ad was first uploaded.

Just my thoughts and a comment that I think the FDA should consider when developing its FINAL guidance.

Reminder Ads OK in EU But Not in US. Huh?

Reminder Ads OK in EU But Not in US. Huh?

The Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expanded its practice code to cover all interactions with health-care professionals, medical institutions and patient organizations, including a ban on doctors from receiving payments to attend conferences (see "Big Bad Pharma, Bribery and the New EU Industry Code").

According to the above cited source (WSJ's "Corruption Currents" blog) this was a bit like closing the barn door after the cows have left:

"This comes at a time when the association’s members are trying to drum up business in developing countries, some of which have state-run health systems. Employees of such systems, including doctors and nurses, can be considered foreign officials under the U.S. Foreign Corrupt Practices Act, a 1977 law that bars bribing foreign officials for business purposes.

"To that end, the Securities and Exchange Commission and the Justice Department are in the midst of a sweep of the industry. In April 2011, Johnson & Johnson agreed to pay $70 million to resolve violations, and The Wall Street Journal reported in November 2011 that Pfizer Inc. will pay more than $60 million when its settlement gets finalized.

"Both companies, the Journal reported, ratted on their competitors.

"Those competitors included AstraZeneca, Merck & Co., Bristol-Myers Squibb Co., GlaxoSmithKline PLC and others that have disclosed investigations for possible FCPA breaches. Eli Lilly & Co. was in advanced talks in April 2011 with the Justice Department, and the company said Feb. 24 in its annual results it’s at the same level with the SEC.

"Letters of inquiry to several of the companies, dating back more than a year, laid out several types of of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals."

Any way, I decided to download the new "IFPMA Code of Practice" to see if there was anything interesting or actually new (you can find it attached to the post here). The code is intended to cover "interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products."

This section popped out at me:

5.2 Reminder Advertisements

A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in Article 5.1 above may be omitted. 

The "abbreviated prescribing information" include "an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side-effects."

In other words, it is perfectly OK to promote drugs to healthcare professionals and patient organizations using reminder ads that do not include safety information. Note: these ads must be print ads in professional publications because no such ads would be allowed on mass media such as TV, which reaches consumer audiences. Promotions  of Rx drugs to consumers is not allowed in the EU, reminder ads included.

The U.S. pharma industry does not have a "practice code" for advertising or "marketing" to healthcare professionals, medical institutions and patient organizations. It does, however, have "Guiding Principles" for direct-to-consumer (DTC) advertising, published by PhRMA (the U.S. industry trade association) in December, 2008. Principle 13 states "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." I.e., NO REMINDER ADS!

Of course, PhRMA's principles leave open the door for running DTC PRINT ads, although I haven't seen many of these in the consumer publications I read. The exception is BOTOX, marketed by Allergan, which has NOT signed on to PhRMA's principles (see "PhRMA Intern vs. BOTOX!").

So, why does the IFPMA Code of Practice specifically carve out an allowance for "reminder ads?" Is that a technique often used in the EU to win over the hearts and minds of healthcare professionals? I don't get it.

FDA Mobile Regulatory Fear Mongering by PhRMA

FDA Mobile Regulatory Fear Mongering by PhRMA

In a blog post provocatively titled "An App for That, But For How Much Longer?" (here), PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. You can read the op-ed in this threaded archive: "How safe is that app? Should pharma apps be registered as medical devices?".

The op-ed author, Joel White, executive director of the Health IT Now Coalition, "suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' In the end, this could hinder the way that patients can actively improve their own care," said Conners.

Before I get to destroying the case made by Connors and White, I should point out how these two people are related. White is the president of JC White Consulting, a registered lobbying firm (see here) retained by the Health IT Now Coalition and PhRMA, among others (see here). In her blog post, Connors said "A few days ago, I missed an op-ed in the Washington Times that I just came across today – and I’m glad I did." Joel, you should have DM'd Kate! Whatever! It's nice that White gets paid to write this "independent" op-ed piece that PhRMA can cite as if it were independent! Guys! Wake up! It's the era of transparency! Unfortunately, you can fool some -- maybe even most -- of the people all of the time and that is what keeps PhRMA in business.

Anyway, back to "FDA Mobile Regulatory Fear Mongering." I say "fear mongering" because it can't be true that White and Connors failed to read FDA's July guidance in which it stated that the agency does NOT consider the following types of apps to be mobile medical apps for purposes of the guidance:

"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."

PhRMA/White do not quote FDA because to do so -- as I just did -- would kill the argument that FDA mobile guideline/regulations will stymie pharma from developing apps and will "hinder the way that patients can actively improve their own care." You should also read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

Meanwhile, there are medical apps being created by pharma that SHOULD be regulated by the FDA, IMHO. These are "calculator" apps designed to be used by physicians during diagnoses. One such app had to be "recalled" because of a bug that generated incorrect results. Unfortunately, thousands of physicians may not have heard of the "recall," which merely removed the app from app stores, not from the phones of physicians who downloaded the app. These physicians may still be using the buggy app. See "The Problem with Unregulated 'Calculator' Apps for Physicians: Buggy Software!"

P.S. Connors pointed out that PhRMA has its own medication reminder app for patients: "In fact, we at PhRMA have helped support the Script Your Future campaign, which itself includes medication reminders as a tool."

Just for fun, I signed up to receive reminders. I was, however, somewhat put off by the long legal disclaimer, which said, in part:

"You acknowledge and agree that we provide the reminder service and access to the reminder service as an "as is" and an "as available" basis, that your use of the reminder service is at your own risk, and that we make no representations, warranties or covenants whatsoever with respect thereto. For greater certainty, we do not guarantee that the reminder service will be available, run error-free or uninterrupted, that we will correct all errors or deficiencies related thereto or that all messages sent by you will arrive at their intended destination on time."

ROTFL! In essence, PhRMA says it makes no promises that this app will be useful. How is this supposed to help me improve my care if PhRMA does not even care to fix errors or deficiencies? Not a very consumer-friendly attitude, I must say! BTW, I am sure the FDA did NOT require PhRMA to write that.

The Problem with Unregulated "Calculator" Apps for Physicians: Buggy Software!

The Problem with Unregulated "Calculator" Apps for Physicians: Buggy Software!

At this year's ePharma Summit in New York, I spent a lot of time listening to presentations about pharma mobile apps. There was, for example, a session entitled "I Wish I'd Done That! Mobile" during which panel members reviewed mobile applications they liked but that were produced by rival pharma companies. Surprisingly, although at least one panel member -- Jason Appel, Director, Physician Relationship Marketing, Amgen -- was involved in creating mobile apps for physicians, only consumer-oriented apps were featured.

Appel said he hasn’t seen any mobile physician apps that he wished he had done and agreed with a previous presenter that most were a waste of money. But of the literally hundreds of apps created by pharmaceutical companies, many are for healthcare professionals.

My friend @skypen (Fabio Gratton) has created a web site to keep track of them all -- it's called POCKET.MD. Fabio claims it is "the world's first and only free online service focused exclusively on providing the most comprehensive directory of mobile applications created by healthcare companies for medical professionals, patients, caregivers, and consumers." Here's a screen shot (click on it for an enlarged view):

Practically every pharmaceutical company has one or more apps. The ones I am interested in are apps designed to help doctors in their diagnosis of patients. Big among these are the "calculator" apps, which calculate things such as glomerular filtration rate (GFR), Medication Adherence Rating Scale (MARS), Delayed Graft Function (DGF) Risk, creatinine clearance, dosing algorithms, Body Mass Index (BMI), and, my favorite, Psoriasis Area and Severity Index (PASI).

According to POCKET.MD, the most downloaded app is Pfizer's "Pfizer Rheumatology Calculator" - a rheumatology disease activity calculator that Pfizer developed to allow physicians to "quickly and easily measure the disease activity of your patients without having to use manual calculations. The calculator is easy to use -- simply enter clinical data for your patient into the calculator and it will instantly provide you with the score in a variety of disease activity measures, including: ASDAS ESR & CRP BASDAI DAS28 ESR & CRP PASI And more..."

Unfortunately, this free Pfizer app is no longer available -- it had to be recalled because of "a bug in the app ... gives wrong results" (see "Pfizer recalls Rheumatology Calculator smartphone App").

Back in July, 2011, I warned that bugs in such apps could go un-noticed because there is no independent verification of the software -- no "Good App Seal of Approval" and certainly no FDA approval. See "Checking Under the Hood of Pharma Mobile Apps" where I point out this shortcoming in another PASI calculator mobile app.

But how do you recall a smartphone app? You can remove the app from the app stores around the world, which is what Pfizer did, but that only prevents new downloads. Most apps are downloaded to smartphones and it is not possible for the developer to remove these copies of the app from the phones. The users must do that. Considering that the "recalled" Pfizer app was the most downloaded app tracked by POCKET.MD, there must be many many users (physicians) out there who still have the app on their phones. Did Pfizer send these physicians a "Dear Doctor" letter informing them of the problem and advising them to remove the app from their phones? Probably not. Did the app include a disclaimer that protects Pfizer from being responsible for misdiagnoses due to its buggy app? Probably yes.

Did FDA Entrap Google with Those 14 NOV Letters?

Did FDA Entrap Google with Those 14 NOV Letters?

Con Artist Reveals All About Google Drug Ad Sting - How FDA May Have Entrapped Google Using Those 14 "Infamous" Notice of Violation Letters

In an interesting article in today's Wall Street Journal, a convicted con artist details how he was employed by federal agents -- including agents of the FDA's Office of Criminal Investigation -- to lead a sting operation against Google's illegal drug ad operation (see story here). Recall that last summer Google agreed to pay $500 million to settle DOJ charges that it helped illegal online pharmacies target ads through its AdWords platform. It was one of the largest forfeitures ever paid in the U.S. (see "Google Settles with DOJ - Admits Aiding Illegal Online Drug Sales").

"It was very obvious to Google that my website was not a licensed pharmacy," said David Whitaker, the prisoner who acted in the sting. "There was a part of me that felt bad," Mr. Whitaker wrote in his account of the undercover operation viewed by The Wall Street Journal. "I had grown to like these people." But, he said, "I took ease in knowing they.. knew it was wrong."

What is of interest to me is the timeline revealed in the WSJ article. I added a couple of events to this timeline shown below (click on the image to enlarge it for better readability).

Mr. Whitaker made first contact with Google in March 2009. On April 2, 2009, FDA made public those "infamous" 14 notice of violation (NOV) letters that effectively shut down Rx drug search advertising on Google. In October 2009, comScore data was released that documented this "prompt, precipitous, and prolonged" drop in paid search advertising (see the chart here).

At the time of the announcement of the Google settlement, I suggested that because of FDA's involvement in the case, the agency delayed issuing guidance relating to the proper use of Google Adwords for branded Rx advertising. I suggested that the FDA did this to force Google to the bargaining table and to ultimately accept the draconian settlement terms mentioned above. In other words, FDA was holding Google's pharma Adword business "hostage" until a settlement was reached. See my argument here.

Looking at the above timeline, however, I now believe the 14 letters were sent so that Google might be more easily persuaded to run illegal drug ads to make up for the revenue lost from legitimate Rx drug ads. If true, this looks like a form of entrapment.

Keep in mind that the type of ads targeted in those 14 letters had been running for many years and that I, for one, maintained they were illegal starting way back in 2006 (see The "Girl from Google"). At the time, I submitted a written complaint to the FDA. Why did the FDA wait almost 3 years before getting around to stopping these ads? The answer, I believe, is what I surmised above -- it was simply a ploy to incentivize greedy Google ad executives to fall for the sting. According to the WSJ article, Google's ad executives "worked with Mr. Whitaker to find a way around Google rules."

P.S. Google may have tried an "end run" around the entrapment by coming up with a new ad format for Rx drugs that addressed the issue cited in the 14 FDA letters. This format was announced at the November, 2009, public hearings (see "Is Google the New FDA?"). The ad was actually "beta" tested by Bayer, but to date the FDA still has not formally approved the format and not many other drug companies have used it.

Is There a Cure for Mediocre Pharma Mobile Apps?

Is There a Cure for Mediocre Pharma Mobile Apps?

For new pharma marketing Graduates, I have just one word for you. Are you listening? Mobile!

Mobile is the new "shiny thing" of interest to pharmaceutical marketers. As evidence of this, there are more and more drug industry conferences that are dedicated to mobile or have tracks or whole days dedicated to mobile. Mobile Healthcare Communications 2012, for example, is one of them. I will be at that conference moderating a roundtable discussion on "Overcoming Mobile Healthcare Compliance Challenges." [The producers of that conference are a client, but I am not being paid to write this post.]

According to my currently-running "Predicting the Future of the Drug Industry: 2012 and Beyond" survey, 72% of respondents agree/strongly agree that the next "BIG opportunity for targeted marketing to patients and physicians is mobile apps on smart phones."

Until recently there were not many pharma mobile applications out there worthy of writing about. previously. Most marketers were discussing only SMS (text messaging) as the best example of using mobile to motivate people to take their medicine. Boring!

I have written about issues related to use of mobile devices by pharma, including the following posts and articles:

• FDA Issues Long-Awaited Guidance - for Mobile Medical Apps. Janssen, Look Out!
• The iPad as a Pharma Marketing Platform
• Challenges of Regulating Mobile Medical Apps
• Mining Mobile Health App User Data
• Checking Under the Hood of Pharma Mobile Apps
• Everything You Need to Know About Mobile Platforms

However, most pharma mobile apps that I have seen are pretty mundane as far as marketing/advertising is concerned. There are a few that focus on consumers such as the Sanofi-Aventis GoMeals app, which IMHO has absolutely no marketing ROI for S-A although it is only one part of an overall marketing plan to position S-A as a player in the diabetes area.

Other apps are aimed at physicians, such as Janssen's "Psoriasis" (PASI) app for the iPhone and iPad that may need FDA approval as a medical device (see here).

There are no pharma apps that I know of that directly help to sell drugs or vaccines. I mention vaccines because I just found out about a P&G "Vicks" branded mobile app/device combination that could be a model for improving the sale of vaccines, especially for the flu. It's a mobile advertising campaign for a behind-the-ear thermometer by Vicks that is "designed to display the ad only in areas where there is a high incidence of the flu and only to mothers, the primary purchasers of thermometers" (see "Using Google Data on Smartphones to Target Consumers for Ads").

Couldn't an app like this be created by a pharma company to promote its flu and other vaccines? Or even OTC medicines during allergy season? Perhaps even Rx drugs if Google had the right kind of targeting data?

There are, of course, some regulatory hurdles to overcome. Since the Vicks app is integrated with a device (thermometer), perhaps it should be regulated by the FDA as a medical device.

Another challenge is the relationship between Google and the pharma industry. While Google is bending over backwards to provide help to consumer goods agencies about how best to do display advertising via its network (see "Google Increases Investment in Display Ads"), I don't think Google is providing the same level of services to pharma agencies. A representative of Google recently said "pharma needs to leverage the Internet" and that "pharma was not considered a key client by Google because of pharma’s low spend" (see here).

To create truly useful mobile apps that have ROI, pharma needs to invest more in interactive media overall. Otherwise, it will continue to develop marginally useful apps that are used once and then forgotten, IMHO.

Pfizer & PhRMA Lobby in Support of SOPA

Pfizer & PhRMA Lobby in Support of SOPA

Steve Jobs once said that he'd rather be a "pirate" than join the navy. What he meant was you must think out of the box to innovate. But the world's "innovative" drug industry is the "navy" as far as lobbying in support of the "Stop Online Piracy Act" goes.

The legislation's short title is SOPA (H. R. 3261; find it here). There are several anti-SOPA Facebook pages and at least one called "Boycott SOPA (the companies lobbying for it)." You can get the official list of companies and organizations lobbying in favor of the bill here. Pfizer and PhRMA are on that list. Why? See below.

Many technology companies and web sites have organized a day of protest (today) against this bill and the companion "PIPA" bill ("Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011" or the "PROTECT IP Act of 2011"; find it here). Protesting companies include Google, which has put a censorship bar across its log, and Wikipedia, which has shut down totally today.

Here's some background as published today in the New York Times (here):

The bills in Congress, pushed by Hollywood studios and other big media companies, target websites that let users download pirated movies, TV shows, music and other material in violation of U.S. copyright law. Most of these sites are outside of the United States, but the legislation would give the Justice Department and private companies tools to block them from American consumers. 

For example, Google could be forced to drop an offending site from its search engine results. Or the government could go to court to stop a U.S. company that facilitates online payments to a suspected infringing site. Internet companies say they have neither the time nor the resources to monitor every link on a website or post by a user.

Google, Facebook, eBay and other new media companies also object to rogue sites, but they have repeatedly said the Stop Online Piracy Act, or SOPA, in the House of Representatives goes too far, hurting investment, innovation and the open nature of the Internet. 

Why do Pfizer and PhRMA support these bills? Simple. They believe it is necessary to prevent "counterfeit" medicines from being sold to US consumers by companies outside the US. At least that's why I think they are supporting these bills. I don't find any press releases or blog posts about it on Pfizer's or PhRMA's site. Perhaps they will respond to this post and tell us in their own words why?

If the industry needs help from the government to prevent counterfeit medicines from reaching US consumers, why not support specific laws for that purpose instead of this legislation that potentially can be used to limit the rights without due process of many online publishers -- who do not have anything to do with counterfeit medicines?

UPDATE (Jan 19, 2012): AstraZeneca Backs Counterfeit Drug Legislation

As if AZ heard what I said about pharma sponsoring more specific anti-drug counterfeiting laws, I just learned that's exactly what AZ is doing. From the AZ Health Connections Blog:

AstraZeneca sent a letter to members of Congress today to express support for legislation that would increase penalties for those convicted of counterfeiting prescription medicines. The letters sent to bill sponsors Rep. Patrick Meehan, Sen. Patrick Leahy, Sen. Chuck Grassley and Rep. Linda Sanchez note that the issue of counterfeit medicines is particularly serious via “Internet pharmacies”:

While the total incidence of counterfeit medicines sold in "brick and mortar" pharmacies in the U.S. is estimated to be less than 1 percent of the total market value, the World Health Organization estimates that over 50 percent of medicines purchased from Internet sites without a physical address are counterfeit. 

You can see the World Health Organization fact sheet on the issue here.

The letter concludes:

 Although the trafficking of counterfeit drugs is currently illegal in the United States, the penalties for such activity are the same for the trafficking of other products. The Counterfeit Drug Penalty Enforcement Act would significantly and meaningfully increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. The proposed sanctions and sentencing guidelines would serve as powerful deterrents to pharmaceutical counterfeiting, greatly benefitting patient safety and health. 

 Additional details on the bill can be found here.

FDA Social Media Guidelines May Be Moot If This Court Decision Holds Up

FDA Social Media Guidelines May Be Moot If This Court Decision Holds Up

Drugmakers dissatisfied with the FDA’s use of guidances as a form of policymaking -- including long-awaited guidance for use of social media by the pharmaceutical industry -- could find legal ammunition against the practice in the case "United States of America v. Franck’s Lab," which is pending appeal in the U.S. Court of Appeals for the Eleventh Circuit.

I noted before that the drug industry may be arraying its legal forces to derail the issuance of social media guideline (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media" and "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing").

The ruling being appealed is that FDA does not have authority to enjoin the "long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances." What can this possibly have to do with social media guidances?

According to a recent Washington Legal Foundation (WLF) "Backgrounder" (see "Court Ruling - If Upheld - Casts Doubt on FDA's Use of Guidance Documents"), "While Franck's case involved pharmacy compounding of bulk pharmaceuticals in non-food producing animals, its implications extend broadly to other areas of FDA law, particularly as it relates to FDA’s increasing use of guidance documents to expand regulatory requirements. In the past year, FDA has issued dozens of important draft guidance documents and final guidance documents, while releasing very few significant regulations. Given FDA’s penchant for issuing guidance documents instead of proceeding through notice and comment rulemaking, the court’s decision may have broad applicability concerning FDA’s ability to regulate or enforce its laws through guidance instead of rules. Indeed, FDA often applies draft guidance documents as if they represented binding obligations. It sometimes even references the contents of the document in communications with industry before the document is finalized."

WLF points out another reason the drug industry prefers rulemaking over guidance: "When FDA issues guidance documents," says WLF, "it tends not to acknowledge the negative comments. The agency typically offers no explanation for why it has opted to stick with its proposed language, rather than making changes to address adverse comments. This failure to respond to comments is not permitted for agencies when they engage in rulemaking [my emphasis]."

This lack of response to comments is a significant factor for social media guidance. The FDA held a public hearing and requested comments on the social media regulatory issues it proposed to write guidance for. Many, many comments were submitted (see "Answers to FDA's Questions Regarding Pharma's Use of Social Media") and so far the FDA has remained mum regarding these comments and may even do so when -- and if -- it publishes more social media guidelines. The recent off-label guidance (see "FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media") also did not refer to any comments the agency may have received.

"If the district court's ruling is upheld," says WLF, "its analysis on FDA’s use of guidance documents is likely to be cited in other FDA proceedings and legal challenges testing the agency’s right to enforce through guidance in lieu of regulations."

P.S. I note that the court case in question involved the death of several ponies due to a compounding error! PONIES! Lucky that it wasn't PEOPLE because I'm sure the court would not be so callous as to strike down FDA's rights in that case.

[Hat Tip to Darshan Kulkarni (see @FDALawyers and website) for providing information about this case.]

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Some time ago, I pointed out that certain mobile apps developed by pharmaceutical companies for use by physicians lack adequate disclaimers. Specifically, I was concerned about the software used in these apps that perform calculations to generate data to aid in medical diagnoses. A Psoriasis/PASI app by Janssen Pharmaceutica is an example (see "FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It"). I pointed out that this app does NOT include any information about the clinical validity of the PASI calculator nor does it warn the user not to depend on the accuracy of the data.

Today, I found out about AFib Educator 2.0 developed by Sanofi-Aventis (I seemed to have missed 1.0!). The app is intended to be an "interactive way for healthcare providers to illustrate atrial fibrillation and its pharmacologic management for patients and families" (see review on iMedicalApps blog). The "pharmacologic management" is not what you may think; that is, there is no mention of any AFib drug either by trade name or generic name. The app only mentions that "there are treatments available."

Let's look at the disclaimers for these two apps (click the image for an enlarged view):

On the left is the disclaimer for Sanofi's AFib Educator 2.0 and on the right is the disclaimer for Janssen's PAS calculator (updated since I last reviewed the app).

Both disclaimers mention that the app is "not a substitute for medical advice/professional medical care". But only the AFib disclaimer mentions that "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein." It also mentions that data might be updated periodically -- meaning, I suppose, corrections or more accurate data.

Why doesn't Janssen's Psoriasis/PASI app, which is MUCH more data driven (it calculates a PASI score!), include a similar warning? Obviously, I think it should include that warning.

But more importantly, Janssen's app should include information about the source of the equation it uses to calculate PASI. As I pointed out previously (op cit), there is some difference of medical opinion regarding how PASI should be calculated and which formula should be used by healthcare professionals.

Obviously, ANY healthcare professional can download and use the PASI app. You don't have to be a dermatologist who may be more familiar with PASI calculations than is a general practitioner. In fact, you don't have to be a physician at all! That's fine, but the audience should be made more aware of what's operating "behind" the app to generate the PASI scores.

Be Aware of What's Behind the App
What's going on "behind the app" is a hot topic these days. Recently, major news outlets have reported that there is software running in the background on virtually all smart mobile devices that record every keystroke, supposedly merely to "monitor performance" (see "Is Your Smartphone Tracking Your Keystrokes, Texts and Location?" and the YouTube Video embedded at the end of this post).

It's interesting that part of Janssen's NEW disclaimer HINTS that data are being collected when people use its Psoriasis/PASI app (see screen shot below).

Janssen claims that it is monitoring clicks for performance purposes. However, since it is possible to collect and record ALL keystrokes, there is the possibility that data other than icon clicks are being collected by Janssen. I'll have to see if Trevor Eckhart -- who made the video below -- will take a look at exactly what data the Janssen apps records.

Is the Pharma Industry Responsible for FDA's Delay in Issuing Social Media Guidelines?

Is the Pharma Industry Responsible for FDA's Delay in Issuing Social Media Guidelines?

I just read an interesting MM&M piece about how measures to curb the deficit might impact the pharmaceutical industry (see "Pharma Marketing Outlook 2012: Detailing D.C."). One small comment caught my attention: "A first draft of what is likely to be one of several not-crystal-clear guidances on social media and Internet communications has been circulating at FDA for most of the year, held up over legal worries." [my emphasis]

Oddly, no details were offered regarding the nature of the "legal worries." As the author of the MM&M piece probably knows, I wrote about this back in July when I suggested that a "Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance" (here). The petition asks for "comprehensive, clear and binding regulations" as opposed to "guidelines," which are non-binding (ie, can easily be changed by the FDA).

Before granting a petition, FDA staffers evaluate it, "a process that may take several weeks to more than a year, depending on the issue's complexity," according to the FDA.

Why is this such a big deal? I have pointed out that if the petitioners -- Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis -- are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" ( further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

In particular, the petitioners are looking for more guidance in four key areas: scientific exchange, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines, and responding to unsolicited requests for information. It seems that the FDA changed its social media agenda -- thus further delaying issuance of guidance -- to satisfy these specific needs (see "FDA Drops Social Media from Its 2011 Guidance Agenda").

You can find and read the petition here.

Another, related, "legal worry" that could be holding up FDA's issuance of social media guidance is a "friends of the court" brief to the court hearing the appeal of the Caronia off-label promotion case. This petition was filed by some of the same pharmaceutical companies mentioned above (see "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing"). The companies -- who call themselves the Medical Information Working Group (MIWG) -- contend that FDA's regulations "lack coherence and clarity." MIWG is talking about regulations regarding off-label information disseminated by regulated companies such as themselves.

This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."

Are Pharma Sales Reps Service Employees?

Are Pharma Sales Reps Service Employees?

The Supreme Court agreed to decide whether drug companies have to pay their sales representatives for working overtime hours, "a question that could have considerable financial impact on the industry," according to the Wall Street Journal (see "Supreme Court to Decide if Pharma Reps Are Exempt from Receiving Overtime Pay"). The question (see here) before the court in case "CHRISTOPHER V. SMITHKLINE BEECHAM CORP" is:

The outside sales exemption of the Fair Labor Standards Act exempts from the overtime requirements of the Act "any employee employed ... in the capacity of outside salesman (as such terms are defined and delimited from time to time by regulations of the Secretary ...)." 29 U.S.C. § 213(a)(1). The Secretary of Labor has implemented various regulations that "define and delimit" the outside sales exemption and, filing as amici in this and other related matters, has interpreted these regulations to find the exemption inapplicable to pharmaceutical sales representatives. A split exists between the Second and Ninth Circuits concerning whether this interpretation is owed deference and whether the outside sales exemption of the Fair Labor Standards Act applies to pharmaceutical sales representatives.
The questions presented are: 

1. Whether deference is owed to the Secretary's interpretation of the Fair Labor Standards Act's outside sales exemption and related regulations; and  
 
2. Whether the Fair Labor Standards Act's outside sales exemption applies to pharmaceutical sales representatives.

If the Supreme Court rules that pharma sales reps are NOT exempt as per Q#2, some sales reps worry that they will become "service" employees. "This will be a similar model to UPS / Fed Ex etc. Log in.............track activity..........gps............clock out at 5:00 pm." (see this CafePharma thread in the GSK discussion board).

This is interesting considering that the pharmaceutical industry is now moving away from the sales force being the primary channel of promotion focused on a narrow stakeholder audience to that of "a multi-faceted influence model where it has to really maximize its return on investment,” according to Mark Sales, Head of Global Brand and Stakeholder Management at Kantar Health (see "The Changing Pharma Commercial Model in 2010 and Beyond"; a PMN article sponsored by Kantar Health). The new sales model drivers are all about becoming more customer-centric and service model-focused. So, a NO ruling by the Supreme Court in this case would be a good thing for the pharmaceutical industry, aside from the billions in additional expenses?

Reps also worry that their companies would cut back on the number of sales reps and overtime hours to forestall the added expenses going forward. "The problem is that if overtime has to be paid out it will lead to more cuts," said an anonymous CafePharma poster. "Lets face it, the impact of reps has been going down for quite a while."

What do pharma sales reps do in "overtime" (after 5 PM) anyway? It may be "role-playing": "Would the role playing to India at 9:00pm count as overtime?," asks another anonymous CafePharma poster. "Get ready for bye bye role plays after 5pm," said another.

Some reps do not think this is an issue at all: "Since most reps really only work a couple hours a day, this really looks like a non-issue." To which this response was made:

"Actually it's a huge issue! Other big pharma companies have had to pay and pay big! This could cost GSK hundreds of millions. As to your comment about a couple of hours, please stop with that nonsense. I avg about 9 hrs per day. It's not back breaking work (that's why I went to college) but it is work. Inventory at the storage facility, lifting boxes, conference calls, emails, coordinating lunches/dinners, knowing and understanding the complex molecules and how they interact invivo/invitro, analytics, ability to utilize Microfoft word/excel, intrapersonal skillls, the list goes on an on...oh but you say reps only work 2 hours. When are reps supposed to answer email, voicemail, build a business plan? On their office day? Ohhhh that's right, there is no office day. So when does all this work get done? According to you we only work 2 hrs a day. C'mon dude! Look, I'm not saying the law suit is a good thing, but the pharma companies had their cake and got fat eating it."

Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing

Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing

"FDA’s regulations censor manufacturers," says the Medical Information Working Group (MIWG), an "informal" group of pharmaceutical companies that includes Allergan, Amgen, Boehringer Ingelheim USA, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk, Pfizer, Purdue Pharma, and sanofi-aventis U.S.

In a "friends of the court" brief to the court hearing the appeal  of the Caronia off-label promotion case (see here), the MIWG contends that a manufacturer that "speaks about the lawful off-label uses of its products subjects itself to potential enforcement action unless FDA and DOJ determine, in their sole discretion, that they will not treat the speech as evidence of an 'intended use' for the product. This creates a chill on manufacturers’ speech, which has serious potential consequences for physicians, patients, and the public health."

Because of FDA's regulations that "lack coherence and clarity," MIWG claims physicians will have difficulty obtaining "objective, balanced, and accurate information on important unapproved uses of approved products." Furthermore, MIWG contends that pharma companies are "uniquely positioned to provide physicians with such information."

That's rich, considering that the drug industry often has difficulty providing "objective, balanced, and accurate information" on APPROVED uses of drugs as evident from all the FDA warning letters, which address this difficulty (for a list of the most recent letters, see here).

Should the heat the drug industry is bringing against FDA's off-label authority succeed, I envision off-label "woolly mammoths" (aka, sales reps) breaking free of the chilly ice and running amok among physicians offering "objective, balanced, and accurate information" - all without any oversight!

Much has been written about this legal issue, which you can find here, here, and here. Aside from the "objective, balanced, and accurate" claim, what caught my attention in the language of the brief was the overlap in the arguments presented with arguments pharma (eg, Pfizer) has made about how FDA should (or should not) regulate the promotion of Rx drugs via the Internet and social media.

On page 10 of the brief, for example, the argument is made that so-called "safe harbors" (eg, FDA guidelines for distribution of off-label reprints; see "FDA's Good Reprint Practices Guidance") are "not the product of formal rulemaking" and are "in most instances explicitly 'non-binding'." This was the argument Pfizer made against FDA issuing social media guidelines (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). As part of that argument, Pfizer said that "for FDA to regulate in this sensitive area [social media] through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result." (NOTE: Both documents are written by some of the same lawyers.)

Another parallel appears on page 11 of the brief, which delves into "unsolicited requests." The brief noted that FDA allows pharma company representatives (eg, paid physician speakers) to provide off-label information in response to an "unsolicited request" (eg, a question from the audience; perhaps from a physician "planted" in the audience for that specific purpose?).

Recall that the FDA's 2011 guidance "agenda" called for the agency to issue guidance regarding "unsolicited requests" from any source, including the Internet. That particular guidance, says FDA, was part of its promised social media guidance (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Before FDA can do THAT, it has to contend with the legal issues raised by MIWG in its brief.

This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."

In Memory of Steve Jobs Will Novartis Sales Reps Really Embrace iPads?

In Memory of Steve Jobs Will Novartis Sales Reps Really Embrace iPads?

Pharmalot reported today that "In a memo this morning, David Epstein, who heads Novartis Pharmaceuticals, wrote that before the end of next year, more than 80 percent of the sales reps will give up their PCs and switch all detailing and related work to iPads.'' The memo, which can be found here, is reproduced below:

Posted on 9:52 AM, 06 October 2011
In memory of Steve Jobs - a role model 

"Today a great man has died - one who has forever changed the world. A great innovator, a corporate leader and a visionary who would not take no for an answer. A man who could perceive customer desire in a very clear way, marry it with technology and compel an organization to execute at the highest level to deliver customers a truly unique and compelling experience. A man I adopted as a role model as we began to galvanize our organization to launch Afinitor at a meeting of our Oncology leadership held in Mexico in 2008. 

"Ultimately, after a long fight, he succumbed to the ravages of PNet (pancreatic neuroendocrine tumor), a cancer for which Novartis now has two approved medicines: Sandostatin LAR and Afinitor. With Steve Job's death it is clear that we cannot rest as we work to discover, develop and commercialize still better medicines. It is medical intervention - great doctors, surgery, medicines and more - that allowed us to enjoy having Steve on this planet just a little bit longer so he could inspire a new generation and give us great inventions like portable digital music, the iPhone, the iPad and iCloud. 

"In his memory we commit today that more than 80 percent of Novartis Pharmaceutical field forces around the world will give up their PCs and be executing their call planning, detailing, emailing, and communicating with each other and physicians via iPads before the end of 2012. Please help me to make this a reality. As a result we will be able to make more impactful calls thus better able to ensure that every patient who should be on one of our medicines has access. Our marketers will be empowered to more quickly update digital detail aids and interactive apps with the latest information. Our marketers will better understand almost instantly what our field forces find helpful in their daily work and what is useless. Our field forces will be able to get more of their work done during the day while waiting for their next appointment rather than doing administrative work later in the day. And there are many other possibilities. Let’s use our positive memory of Steve to do some more good in the world. I know we can."

Not so long ago, I was hearing that pharma companies bought iPADs without having a clear strategy for how they were going to be used. It was believed that thousands of these iPads were housed in warehouses and not deployed.

It seems that Epstein is using the "in memory of Steve Jobs" memo as a tool to empty his warehouses of iPads and encourage reps to use them "to get more of their work done during the day" and "do some more good in the world."

But what are Novartis reps saying about the iPad? Here are some tidbits I found on the Novartis board over at Cafe Pharma:

• We are the laughingstock. 'Oh look, there goes the reps that are so incompetent in getting their message across, they are replaced by an iPad!' Hey doc, wanna play Angry Birds with me? 
• Next step in e-detailing is downloading "e-rep" app (doc gets to pick male/female e-rep to interact with,,need samples? click!, need a quick product review? click, heard the latest about managed care in your area? click! 
• Actually...with iPads why do we need high priced reps? The managers will be fine...you...I wouldn't be too sure. 
• I'm going to record all calls with the ipads camera & upload to youtube & publish live as soon as the next severence (sic) is paid out

At least pharma reps are not "selling sugar water to kids" as Steve Jobs once said of John Scully when he hired him to run Apple. Scully promptly ran it into the ground.

Does this memo violate FDA Regulations?

P.S. Epstein's memo was posted to a site called FreePDFhosting.com, which allows anyone to upload PDF files for free (duh!). I am not sure who posted Epstein's memo to this site, but I doubt it was Epstein, who probably intended it to remain an internal document. 

However, now that it is a PUBLIC document, easily accessible by any one, is it subject to FDA regulation regarding branded communications?

I notice that the memo refers to Novartis anti-cancer drugs by brand name and includes the FDA-approved indication: pancreatic neuroendocrine tumor. However, the memo does NOT include any fair balance (major side effect information). Technically, therefore, this memo -- as it appears on FreePDFhosting.com -- violates FDA law. Since FreePDFhosting.com has a rule against uploading PDFs that are "illegal or violates any laws," the memo should be removed from the site (hopefully before the FDA sees it).

BI Masters the Art of WOM through Its "Parrots," er, Spokespersons

BI Masters the Art of WOM through Its "Parrots," er, Spokespersons

Even Social Media Savvy, Personable, Fun-Loving Boehringer Ingelheim (BI) Can Bring Shame to the Pharmaceutical Industry!

No sooner did I give Boehringer Ingelheim (BI) kudos for its recent humorous and playful YouTube video (see here), than I learned it violated Clauses 2, 9.1, 3.2, 22.1 and 22.2 of the ABPI Code of Practice (see "Promotion of Pradaxa by Boehringer Ingelheim Breached ABPI Code of Practice").

You can read the details yourself in the above link. At the core of the case were stories published in UK newspapers based upon a BI press release. BI also provided reporters with access to paid physicians and patient spokespersons.

The case originated from a complaint by a "general practitioner" filed with the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the ABPI Code.

The PMCPA "was very concerned about the content of the press release and the briefing material for spokespersons. The [PMCPA] Panel considered that these would in effect encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel was concerned about the lack of information in a consumer press release relating to side effects."

In the YouTube video mentioned above as well as in a recent tweet, BI said it "believes there are better mktg tools than FB & Twitter." It appears that BI thinks friendly news reporters are among the better tools available to it.

It's amusing that the news articles made some great marketing statements that BI could never make, such as referring to Pradaxa as a "super pill" and a "revolutionary drug." The stories also dissed the competition (warfarin) by referring to it as "rat poison." BI press materials did not refer to warfarin as rat poison and "otherwise made no disparaging remarks about the medicine," said PMCPA, which had no evidence about how warfarin had been described by Boehringer Ingelheim’s spokespersons or at any press conference. Therefore, no breach of the Code was ruled in that regard.

Obviously, what "spokespersons" say falls under "word of mouth" (WOM) marketing, which is what BI says is one of those "better mktg tools than FB & Twitter." As this case demonstrates, it is very hard to prove that pharmaceutical companies are responsible for WOM marketing that violates regulatory and industry rules.

DDMAC's Bad Ad Program Catches Pfizer Using Google Style "bAdWords" on Lipitor Web Site

DDMAC's Bad Ad Program Catches Pfizer Using Google Style "bAdWords" on Lipitor Web Site

This is rich!

Recall that back in April, 2009, the FDA sent 14 "warning" -- actually notice of violation or NOV -- letters to major pharmaceutical companies citing as violative several short Google Adwords such as this Pfizer sponsored Adword for CADUET (find the screen shot of this as archived by FDA here and the letter FDA sent to Pfizer here):

I called such ads "bAdWords" way back in November, 2006 -- 3 and one-half years BEFORE FDA caught on (see "Lunesta, Google, and 'bAdWords'").

Last week (August 31, 2011), DDMAC sent ANOTHER letter to Pfizer about some Google-style violative "AdWords" it found in the “Online Resources” webpage of the Pfizer, Inc. (Pfizer) website for LIPITOR. One of the ads was for -- wait for it -- CADUET! THAT ad looked like this:

The CADUET link ad above is practically IDENTICAL to the sponsored Google ad, which FDA warned Pfizer about more than 2 years ago!

Either Pfizer's legal/regulatory team has NO organizational memory, or it tried to pull a fast one on FDA.

It should be noted that FDA itself did not catch this. It was submitted to FDA's "Bad Ad" program; a name no doubt inspired by my "bAdword" blog post mentioned above. And it was probably one of those other 14 companies that received letters from the FDA in 2009 that ratted on Pfizer (see "Majority of Bad Ad Complaints Submitted by Pharma 'Representatives' Deemed Worthy of 'Comprehensive Review' by FDA").

[This post originally appeared in Pharma Marketing Blog. 

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