Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).

[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]

The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.

In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.

Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):

In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”

“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.”

PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."

This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.

FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:

(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. One comment stated that because these products can only be purchased after a discussion with a health care provider, the study be redesigned so that consumer perceptions are measured after a discussion with a health care provider.

(Response) We concur that this study does not address behaviors, such as how ad perceptions are translated into a discussion with a health care provider. As noted previously, one purpose of DTC advertising is to motivate consumers to engage in a discussion with their health care provider about health concerns. Another purpose, supported by research findings (Refs. 20 and 21), is to increase awareness of available treatments. DTC advertising does not exist solely in the confines of a doctor's office; rather, DTC advertising targets consumers outside of a doctor's office, with the goal of prompting consumers to ask their physicians about the product. In deciding whether or not to discuss a particular product with their health care provider, consumers presumably are engaging in some sort of judgment about the product being promoted. Therefore, clear communication of risks and benefits is needed for consumers before a consultation with a physician, and it is valid to measure these impressions.

FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"

FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"

In a recent Federal Register notice (find it here), FDA outlined a study it plans to do to determine if disease awareness information in branded ads confuses consumers; i.e., if consumers confuse educational information about a disease with specific product claims approved by the FDA. As usual, FDA will only study print ads -- not Internet-based ads.

"Sponsors [pharmaceutical companies] may choose to include disease information in their full product promotions," says FDA. "Such information is designed to educate the patient about his or her disease condition. However, in some cases a full description of the medical condition may include information about specific health outcomes that are not part of a drug’s approved indication... When broad disease information accompanies or is included in an ad for a specific drug," says the FDA, "consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement."

FDA cites as an example a hypothetical ad that mentions "diabetic retinopathy," which is damage to the eye's retina that occurs with long-term diabetes. "...the mention of diabetic retinopathy in an advertisement for a drug that lowers blood glucose may lead consumers to infer that the drug will prevent diabetic retinopathy, even if no direct claim is made. The advertisement may imply broader indications for the promoted drug than are warranted, leading consumers to infer effectiveness of the drug beyond the indication for which it was approved."

I couldn't find a diabetes-related print drug ad that mentioned "diabetic retinopathy," but I did find one in today's Parade magazine that informed me that "Diabetes Damages Nerves." That ad (shown below) promotes Pfizer's drug Lyrica, which is indicated for the treatment of "Diabetic Nerve Pain." It is NOT indicated to prevent nerve damage caused by diabetes.

What I see when quickly glancing at this ad is "DIABETES DAMAGES NERVES" (all caps), then "PAIN," (also all caps) and, finally, "LYRICA" (also all caps). If I were a typical consumer with diabetes, I might think that LYRICA prevents damage to my nerves, which would be an incorrect assumption.

BTW, the ad also says "Lyrica is believed to work on these damaged nerves." What does that mean? Does Lyrica work on repairing the nerves? or does it work on shutting down the nerves so you don't feel pain? And, what does "believed" mean? It's all very mysterious!

This ad probably is not the best example of an ad that FDA has in mind -- it was just the best example I could find at the moment. I'll have to buy a few more consumer magazines to find other, more relevant examples. If you know of one, please point it out to me.

Abbott's Anti-Biosimilar Stance is Anti-Consumer

Abbott's Anti-Biosimilar Stance is Anti-Consumer

The pharmaceutical industry often wonders why it has such a bad reputation with consumers -- nearly as bad as the tobacco industry -- considering it saves lives, as opposed to the tobacco industry, which ends lives. Well, to understand why this is so, you need look no further than actions such as Abbott's April 2, 2012 citizen's petition against FDA approval of biosimilars (read more about that and find a copy of the petition here: "Abbott Labs Petitions FDA to Disallow Biosimilars").

According to the FDA (here):

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

The law protects the original biologic drug from copies for 12 years after approval.

"If the challenge succeeds," says WSJ, "less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira, which had $3.4 billion in U.S. sales last year and is projected to be the world's No. 1-selling drug this year."

Abbott "contends that its drug isn't copyable under the law, because regulators would need its Humira trade secrets to approve a biosimilar and would thereby violate its constitutional rights. The company said it is protecting an investment of 'massive amounts of capital' and the 'great risk' it took developing the drug. In fact, Abbott contends that no biologic approved before the law was signed should be considered copyable."

"Critics of Abbott's position say that the argument lacks merit and is anticompetitive, and that trade secrets aren't necessary to prove that a copy will work like the original. The critics also contend Abbott is backtracking on its support for the legislation and ignoring the potential impact on the country's spiraling health-care spending."

Considering that Abbott Labs will soon have the NUMBER 1 selling drug in the world (see below) -- taking the crown from Pfizer's LIPITOR -- it makes perfect sense that Abbott should act NOW to protect its patented money-maker, years before it finds itself in the not-so-envious position of Pfizer, which fought on even after the bell rang on Lipitor (see "Pfizer Throws In the Lipitor Marketing Towel"). Note: Humira's U.S. patent expires in December 2016

With the filing of this petition, Abbott Labs may also take on another "crown" previously held by Pfizer -- the world's most hated pharmaceutical company. Good luck with that Abbott.

Booming Biologics
Abbott, however, is just the "poster boy" (or "patsy") chosen by the drug industry to take the shots by filing this petition, which really speaks for the entire industry. Patented biologics is a big business and represents the future of the pharmaceutical industry.

According to the WSJ, biologics "had $74.8 billion in U.S. sales last year, up 8.3% from the previous year, according to the IMS Institute for Healthcare Informatics. This year, seven of the 10 top-selling drugs will be biologics, with a total of $50.4 billion in world-wide sales, according to EvaluatePharma, which predicts that Humira will be No. 1 with $9.3 billion in world-wide sales."

Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!

Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!

Two days ago, I sent an email to FDA's "Bad Ad" program (email addr: BadAd@fda.hhs.gov) to cite a Pfizer iPhone App as a "Bad Ad" (see "Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?" for background). For the record, here's a screen shot of the email I sent (click on it for an enlarged view):

A minute later, I received an acknowledgement email from the FDA that started with "Thank you for taking the time to alert us to potentially misleading promotion," but ended with "If you are not a healthcare provider, please refer to the OPDP website for instructions on how to submit a complaint, or call (301) 796-1200." I was confused, so I called the number and left a message.

Today, Olga Salis, OPDP Senior Project Manager, called me back to explain the Bad Ad complaint process. It appears that "healthcare professionals" (i.e., mostly physicians) can submit complaints about ads via email whereas ordinary citizens such as myself MUST use snail mail; i.e., send a physical letter to FDA/CDER/OPDP, 5901-B Ammendale Rd, Beltsville, MD 20705-1266. This distinction is not clear from the information provided on the Bad Ad page here.

It's OBVIOUS that the FDA does not want to be bothered or flooded by consumer complaints because it is not making it easy for consumers to submit complaints. Who knows if FDA would have done anything with my complaint had I not called. As it is, it may take OPDP THREE months to respond or take action on my complaint, "if it has merit."

NOTE: FDA receives complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see figure below and also here):

Source: pharmamkting.blogspot.com via Pharma on Pinterest

I will followup with a written letter sent to OPDP. However, I encourage any healthcare professional reading this blog to download the Pfizer iPhone app in question and if you agree with me that it is worthy of a "bad ad" complaint to the FDA, then all you have to do is send an email to BadAd@fda.hhs.gov. Easy for you, not so  much for me :-(

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

If you think waiting over two years for FDA to issue guidelines it promised for regulation of "Promotion of Prescription Drug Products Using Social Media Tools," then you should take a look at the following timeline and weep.

This timeline documents the major steps in FDA's process of developing guidance for direct to consumer television (DTC) and radio ads; ie, "standards that would be considered in determining whether the major statement in direct-to-consumer television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner":

• 1 November 2005: FDA convenes a 2-day public hearing to discuss the issue (see "FDA DTC Hearings: Snippets from Day 1" and "DTC Pros and Cons Presented at Public Hearing"). Sound familiar?


• 21 August 2007: FDA announces it will conduct a study of "consumer evaluations of variations in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." It opens a 90-day period to submit comments regarding this study. This study used the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. I suggested FDA NOT use Chinese characters because that would be discriminatory, but they did not listen to me (see "FDA at a Mall Near You: The Manchurian Connection"). With regard to social media guidelines, the FDA has also announced it will do some studies before issuing guidance (see "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"). Deja vu all over again!


• 29 March 2010: FDA finally publishes the draft guidance, more than 4 years after the public hearing (see Federal register ref: 75 FR 15376). FDA was goosed along by an act of Congress: the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA was forced into RULEMAKING mode rather than GUIDANCE mode, which is how the pharma industry wants the agency to approach the regulation social media drug promotion as well (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").


• June 2011: FDA published an executive summary of a study of the methodology of the AMP study cited above entitled "A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure" (find it here). Maybe FDA read my comments after all!


• 27 January 2012: FDA announced that it added a document to the docket for the proposed rulemaking concerning a study entitled: "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study; see Docket No. FDA–2009–N–0582). This document reopened the comment period (extending the deadline to February 27, 2012) for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards. Way back during the public hearing in 2005 I was unimpressed by research claiming that TV drug ads were designed to "distract" viewers from reading the fair balance (see op cit and "Ruth Day and the Bees Repeat Performance at House DTC Hearing" for an update on that).


• 23 March 2012: FDA reopens the comment period for a second time "in response to a request for more time to submit comments to the Agency." The new comment period will expire on April 9, 2012. According to the FDA, the "Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a letter dated February 20, 2012, requesting an additional 15 days for interested persons to comment. FDA believes that an additional 15 days to comment on the Distraction Study as it relates to the proposed standards is appropriate."

What strikes me are the similarities between the evolution of these DTC guidelines/rules and the long-awaited social media guidelines.

First, there are the delaying studies and studies of studies. It's well-known that if you wish to halt progress, do a study.

Second, I sense that the drug industry pushed the FDA into RULEMAKING rather than issuing guidelines although it took an act of Congress to do that in this case. The drug industry may use the courts in the case of social media (another example of how an "activist" judiciary can work both sides of the aisle).

If it takes the FDA SEVEN or more years to complete this process for TV ads, I imagine it will take them 10 years to finalize guidance or rules (whatever!) for regulation of the use of social media for drug promotion. While TV has more or less stagnated during the seven years since 2005, social media will look completely different by the time those 10 years are up in 2019!

Medical Device Marketing Don't Need No Stinkin' ROI!

Medical Device Marketing Don't Need No Stinkin' ROI!

"Standards for devices exist, they just don't make sense," industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release (also read this CBS report "Investigation: Most medical devices implanted in patients without testing"; see video below).

"An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:

• Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
• There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
• Without major changes in the system, there’s not much that patients can do to protect themselves.

According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.

In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson's Ethicon unit (see "J&J Marketed Medical Device Without FDA Approval").

Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.

That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this Pharma Marketing News article: "Medical Device Marketing: Worlds Apart from Rx Drug Marketing"; use discount code 'DEV444' BEFORE April 15, 2012 to get it FREE!).

While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketers don't need to worry about no stinkin' ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval.



Although the FDA has met most of its goals for fast-track medical device approvals, it's taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO). The GAO said:

"FDA has begun to take steps to address GAO’s 2009 recommendation about high-risk devices that are allowed to enter the U.S. market through the less stringent 510(k) process, but progress has been limited. High-risk devices include those which are implantable or life sustaining. In 2009, GAO recommended that FDA expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process. Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA’s action on the 26 remaining types of high-risk devices was incomplete. Thus, these types of devices—such as automated external defibrillators and implantable hip joints—can still enter the U.S. market through the less stringent 510(k) process. GAO found that, since its report was issued in January 2009, FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types. FDA has taken some additional steps to enhance premarket device safety since GAO’s 2009 report was issued—for example, it commissioned the Institute of Medicine to conduct an independent review of the premarket review process—but it is too early to tell whether any forthcoming changes will enhance public health."

To get a copy of the GAO report, see the end of this post: "FDA Taking Longer to Approve Medical Devices, Says GAO"

Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"), is now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative.

If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won't kill humans outright! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug's efficacy will be proven (or not) in the marketplace.

Instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy," says von Eschenbach in a WSJ Op-Ed piece (see here), "after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."

This is free market economics gone wild!

Currently, "post-market studies" are a undertaken to test the SAFETY of drugs as they are used in the real world. Such studies are not required of all drugs. What von Eschenbach proposes is to use post-market studies to test if drugs work as advertised, not if they are safe.

The problem is that post-market studies are NOT scientific because there are no controls to determine a baseline against which to measure efficacy. It's easy to find safety problems because that does not require controls.

I am amazed that von Eschenbach headed up the FDA and before that the National Cancer Institute! The fact that he is advocating tossing the scientific method aside takes my breath away considering that he is now well-positioned in the conservative political arena and no doubt has hopes that a future Romney or Gingrich administration will appoint him FDA commissioner or worse, Secretary of the Department of Health and Human Services!

Google's Settlement with Justice Department Paves Way for FDA Social Media Guidelines

Google's Settlement with Justice Department Paves Way for FDA Social Media Guidelines

Google has agreed to pay $500 million to settle DOJ charges. In the settlement, Google acknowledged 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").

This will help the pharmaceutical industry and FDA in their long-standing battle against US citizens buying drugs online from Canadian pharmacies.

It will also pave the way for the FDA to release long-awaited guidelines for the use of Google Adwords and other "space-limited" online applications (eg, Twitter) by the pharmaceutical industry for branded drug promotions.

I pointed out previously (see here) that as part of the DOJ criminal investigation, undercover agents for the Food and Drug Administration contacted Google posing as representatives from rogue Internet pharmacies.

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

Recall that the brouhaha with Adwords as far as pharma marketers were concerned all started with FDA issuing those 14 warning letters in April 2009. These letters were all about Google's Adwords. I had also pointed out long ago that Google was aiding and abetting illegal pharma Adwords by suggesting exactly the format that the FDA later found violative (see "That Girl from Google").

Now that Google settled, FDA should be willing to give back to the search engine giant its pharma Adword business, which was substantial prior to the 14 letters.

P.S. Back in April 2009, shortly after the FDA sent out the 14 letters, I asked this question: "WHY DID IT TAKE THE FDA THIS LONG TO GO AFTER VIOLATIVE ADWORDS WHEN I WARNED THEM ABOUT THIS AS FAR BACK AS 2006?" (see here).

At that time, I thought it had something to do with the new administration in Washington, DC. But I learn now from the DOJ press release (here) that "In 2009, after Google became aware of the investigation by the Rhode Island U.S. Attorney’s Office and the FDA/OCI Rhode Island Task Force of its advertising practices in the online pharmacy area, and as a result of that investigation, Google took a number of steps to prevent the unlawful sale of prescription drugs by online pharmacies to U.S. consumers."

Maybe the release of the 14 letters was the incentive Google needed to "take a number of steps."

Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements (83 full unique advertisements) in biomedical journals found that only 18 percent (15) were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death. The study was published online on August 17, 2011 in the journal Public Library of Science (PLoS) One (here; also see press release here).

I've had some communication about this study with Dr. Deborah Korenstein, MD, Associate Professor of Medicine at Mount Sinai School of Medicine, lead author of the study, and Joseph S. Ross, MD, Section of General Internal Medicine, Yale University School of Medicine, a co-author of the study.

The major question I had was what "FDA guidelines" did they use to measure compliance against? The article was very non-specific in that regard, but I was sent the "Master Guide for Ad review," which was used to assess compliance with 20 FDA "Guidelines" (find the Guide attached to this post).

Actually, "guidelines" is the wrong term to use because what the authors used to create their assessment "Master Guide" was the original FDA "Regulations" (ie, Code of Federal Regulations Title 21, Sec. 202.1 Prescription-drug advertisements; find it here).

For example, one of the assessment items asks reviewers: "Are there unsupportable efficacy claims related to comparisons with other drugs?" In support of that, the authors cite this language in the Code: "Contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience." This is just one of the reasons that would make an ad "false, lacking in fair balance, or otherwise misleading" according to the regulations.

So, in short, the authors played the role of DDMAC reviewers and, based on THEIR interpretation of the regulations, determined if the ad under review was non-compliant with FDA "guidelines."

I took the liberty of plotting some of their results. Looking at the glass half-full, the following chart shows Percentage of Ads that are completely ADHERENT with FDA "guidelines" according to this study:

When assessing content, the reviewers looked at issues relating to "Safety," "Efficacy," and "References," as well as other content issues.

As can be seen in this chart only 47% of the ads (N=83) were deemed adherent to FDA "guidelines" regarding efficacy. The questions authors asked themselves when reviewing the efficacy claims in ads were:

1. Does the ad quantify benefits?


2. Were appropriate efficacy data or numbers presented?


3. Are there unsupportable efficacy claims related to comparisons with other drugs?


4. Are efficacy claims based on non-clinical data?


5. Are there unapproved efficacy claims?


6. Does the ad make unfounded claims regarding competitor drugs or does it claim inaccurately that advertised drug differs from other drugs?

For each question, the reviewer could check off "Yes," "No," "Not Sure," or "NA." Reviewers used language from the FDA regulations cited above to subjectively decide the answer. For example, in support question 4, the assessment guide quotes this language from the FDA regulations: "Contains ...data or conclusions from non-clinical studies ... which suggests they have clinical significance when in fact no such ...significance has been demonstrated." Ads that fit that description -- as subjectively determined by the reviewer -- were judged "Non-Adherent."

According to the researchers:

"Advertisements were considered adherent if they contained none of the 21 [actually 20 according to their "Master Guide"] features used by FDA to classify advertisements as misleading, non-adherent if they contained one or more of the features used by FDA to classify advertisements as misleading, and possibly non-adherent if there were no features clearly defining a misleading ad but at least 1 of those items for which information was incomplete."

Sometimes, the reviewer was "not sure" if the ad was adherent or not. In the case of efficacy claims, 31.3% of the ads fell into this category, while 21.7% were judged "non-adherent." The remainder -- 47% -- were "adherent" as shown in the chart above.

Well, if the MD reviewer is "Not Sure," maybe an actual FDA reviewer might also not be sure. But in that case, the ad would be put into the "adherent" bin. In other words, an FDA reviewer might consider that 78.3% (47% + 31.3%) of the ads were actually adherent with regard to efficacy claims.

The problem, note the authors, is that the FDA is NOT catching the ads that according to them are obviously non-adherent. Why not? "The limited resources of the FDA's Division of Drug Marketing and Advertising [DDMAC] are a major barrier to successful regulation of the pharmaceutical industry's multi-billion dollar marketing budget," said Dr. Korenstein who notes in the research paper that "DDMAC’s fiscal year 2008 budget of $9 million is dwarfed by the pharmaceutical industry’s $58 billion marketing budget."

"We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements," said Dr. Korenstein.

First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information

First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information

Yesterday, my post "FDA Drops Social Media from Its 2011 Guidance Agenda" (here) created quite a stir on Twitter. We had a good discussion of this on last nights #socpharm chat.

All the hubbub revolved around the fact that FDA's 2011 guidance agenda did NOT include "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda. What IS included in the 2011 agenda, however, is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet."

I didn't understand what "Responding to Unsolicited Requests" had to do with social media and technically, FDA's 2011 guidance agenda does NOT mention social media, hence the title of my blog post.

Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC, however, seemed to insist that FDA was still committed to develop guidance for social media, but offered no specific details.

Looking back at FDA's Federal Register notice regarding its November, 2009 Public Hearing (see here), I find absolutely no mention of "unsolicited" ANYTHING, including no mention of "unsolicited requests for Prescription Drug and Medical Device Information."

So, why did the FDA put "Responding to Unsolicited Requests" at the TOP of its list of "issues related to Internet/social media promotion of FDA-regulated medical products" for which it promises to issue guidance in 2011? Where did that issue arise? It wasn't mentioned in the Federal Register, as I said.

So, I decided to look in the transcripts of the Public Hearing and found ONLY one mention of "unsolicited" and it was in the November 12, 2009, presentation made by Mark Gaydos, Senior Director of U.S. Regulatory Affairs, Marketed Products at sanofi-aventis. Gaydos spoke on behalf of the Social Media Working Group, which included representatives from Amgen, AstraZeneca, Bristol-Myers Squibb, Millennium Pharmaceuticals, and sanofi-aventis U.S. He spoke specifically about practical approaches for the pharmaceutical industry's "engagement in online communities or social media in a compliant manner."

Gaydos envisioned "specific scenarios where we're talking about unsolicited questions that are posed on a company-sponsored site." One specific scenario involved questions about "off-label" use of a company's drug. Gaydos said, "with off-label questions there is already an accepted way for companies to in a compliant fashion respond to those questions," but "It's difficult to apply the same criteria here with the off-label statements."

Gaydos imagined the following scenario: "You can imagine, for instance, someone visits a company site, and there's a community hosted on that site, and they mention, oh, I'm taking your product for a specific condition, and that happens to be an off-label use of the product. However, it may have been deemed medically appropriate by their physician. Imagine how you would feel if you did something like that, and you were told by a company, that's an inappropriate use of our product, when, in fact, the doctor said it is appropriate." That could harm the patient-physician relationship, said Gaydos.

So here we have a social media scenario put forward by a coalition of pharma companies for which the FDA might issue guidance in 2011. And that's what FDA means by "Responding to Unsolicited Requests" (more accurately, "unsolicited statements").

Listen to my February, 2010, Pharma Marketing Talk interview of members of the Social Media Working Group (click the play button in the widget below):



NOTE: Facebook's NEW comment policy may also be a motivating factor. See "New Facebook Policy "Kind of Hurts" Pharma Marketers"

FDA Drops Social Media from Its 2011 Guidance Agenda

FDA Drops Social Media from Its 2011 Guidance Agenda

I just downloaded the "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2011" from the FDA site (find it here).

Missing from this agenda is "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda (see here).

However, included in the 2011 agenda under the Advertising Category is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet." Is this supposed to be the promised guidance we've all been waiting for? "Responding to unsolicited requests" is NOT a social media issue nor was it one of the questions FDA asked at the November 2009, public hearing (see all the questions here).

I don't know who/what to believe. In February, 2011, Tom Abrams, Head of DDMAC, said "We want to have these [social media] guidances out as soon as possible" (see here). FDA set the end of the first quarter of 2011 as the deadline goal. It missed that goal and hasn't set a new one. Now I see that the 2011 Guidance Agenda doesn't even include social media guidance.

I don't think the FDA is being very transparent and is sending the industry conflicting signals. What do you think?

P.S. See "Breaking – Its Official – FDA Delaying Social Media Guidance Until at Least Q1 2011" which highlighted email from the FDA that had "Responding to unsolicited requests" at the top of the list of social media issues the FDA is researching for draft guidance.

Although social media and the Internet expose pharma companies to unsolicited requests (ie, when they allow comments on Facebook or follow people on Twitter) it is NOT an issue that was discussed at the November, 2009 Public Hearing nor in the comments submitted to the FDA regarding social media.

[I stand corrected. The issue of how to respond to "unsolicited statements" about off-label use of drugs on pharma-owned social media sites WAS discussed at the hearing. See  see "First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information"]

Writing guidance for handling unsolicited requests is a no-brainer compared to developing guidance on how pharma marketers can comply with FDA regulations when space is limited as in search engine ads and tweets. Why isn't the FDA tackling THAT all-important social media issue first? After all, those infamous 14 NOV letters were all about that and NOT about handling unsolicited requests. For my answer to that mystery, see "FDA, DOJ, & Google: Conspiracy Theory, Part 2."

P.P.S. I called and e-mailed Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC. Here's the response I received from her via e-mail:

Hi John,

Thanks for your voicemail and e-mail messages. You should have received an autoreply e-mail from this account with the current status of our policy and guidance development on Internet/social media promotion, which is an Agency-wide effort that involves an extensive work and review process. While "Responding to unsolicited requests..." is listed by name on the 2011 CDER Guidance Agenda, it is only one of multiple topics for which we plan to issue draft guidances. At this point I cannot provide any specific timeframes due to our GGPs as many parties are involved, not just DDMAC. Please know that we are committed to moving forward with policy development in this important area by issuing well-vetted and meaningful draft guidances!

Sincerely,

Jean-Ah

P.P.P.S. For a follow up, see "First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information".

FDA Targets Genetic Testing Services for Advertising Unapproved "Medical Devices"

FDA Targets Genetic Testing Services for Advertising Unapproved "Medical Devices"

FDA recently  (May 11, 2011) sent letters to two DNA testing services concerning their Direct to Consumer (DTC) advertising. The companies are Precision Quality DNA (see letter here) and Lumigenix Inc (see letter here).

Precision Quality DNA, offers a service intended to help individuals "understand the analysis of their DNA sequence while focusing on main target genes, such as BRCA1/BRCA2, to determine that individual’s main risk factors or likely response to a particular drug." FDA claims that the service "appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."

Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or] intended to affect the structure or any function of the body of man or other animals.”

FDA looked high and low in its files and "ha[s] been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Precision Quality DNA. We request that you provide us with the FDA clearance or approval number for the Precision Quality DNA . If you do not believe that you are required to obtain FDA clearance or approval for the Precision Quality DNA, please provide us with the basis for that determination."

Actually, Precision Quality DNA does NOT believe it requires FDA clearance and says so right on its website on a page titled "Health, Politics and Regulatory Issues" (see here). On that page, Andre Gous, Co-Founder of the company and addressee of FDA's letter, has some interesting things to say about the FDA and its authority to regulate software as a medical device, including:

"Even if you're in favor of government regulation, you're probably wondering how a 1976 FDA law could be applicable to DNA biotech -- an entire field of endeavor that was unknown to the legislature at that time. And, since that law focuses on devices, the FDA is (no surprise) also classifying more and more things, even things as ethereal as software, as a 'device.'

"If the FDA were simply deluded, that would have been bad enough already. However, the FDA didn't stop there. They mailed intimidating letters to the top 5 DNA biotech US companies, and since then they have mailed out 14 more such letters yet."

After that it's pretty much an Ayn Rand style rant; ie, government should just leave capitalists alone.

My guess is that Precision Quality DNA was not among the the "top 5 DNA biotech US companies" that previously received letters from the FDA. To paraphrase it's marketing tag line, Precision Quality DNA "Dodged the Bullet with its Name on it" from the FDA in the past, but now has to deal with that bullet. It will be interesting to see who prevails, the bullet or the target.

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.

You can access the PMCPA "informal guidance" here.

While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!

Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the British industry code, US PhRMA's DTC Guidelines specifically excludes online communications.

Regarding Twitter, PMCPA has this to say:

"If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.

"Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

Back in October, 2009, I criticized tweets like this, which I thought violated FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). So far, however, FDA has not issued any NOV letters to companies who post such tweets. Maybe BI is out of the FDA's jurisdiction because the tweet was meant for an EU audience and not a US audience? And since BI is not a British Pharmaceutical industry, it is not obligated to comply with the ABPI Code.

While many industry pundits fault the FDA for not issuing social media guidance in a timely fashion, no one has put any blame on PhRMA (the US industry equivalent of ABPI) for not issuing its own voluntary industry guidelines regarding Internet and social media pharmaceutical promotion. No one but me, of course (see, for example, "PhRMA Finalizes DTC Principles").

Is It Time for Abrams to Leave?

Is It Time for Abrams to Leave?

There were rumors at the recent ePharma Summit that DDMAC would come out with social media guidelines sometime in the next few months -- maybe by April, 2011. The crowd who gathered the following day in the great hall was at first jubilant in anticipation of the speech by Thomas Abrams, Head of DDMAC since 2000.

The crowd's mood changed dramatically, however, when Abrams did NOT mention any specific date during his presentation. Instead, he stated his allegiance to FDA's "Good Guidance Practices," which govern the orderly process of issuing guidance.

It seems that Abrams will remain as head of the hated DDMAC regime for some time to come. But his promises may no longer be enough to stem the growing frustration of the crowd.

P.S. I urge all my readers to support the demands of the Egyptian people for democracy and the ouster of the dictator Mubarak! You can get the best coverage of events by watching the live streaming video with commentary via Aljazeera English here.

Questions I Intend to Ask DDMAC Director Thomas Abrams at the ePharma Summit

Questions I Intend to Ask DDMAC Director Thomas Abrams at the ePharma Summit

I've noticed that FDA's DDMAC Director Thomas Abrams has been making presentations at several recent drug industry conferences. At the 10th Annual ePharma Summit that begins today in New York City (see here), Abrams presentation is titled: "Regulation and Oversight of Prescription Drug Promotion: Update from DDMAC," which is similar to presentations he's made at other conferences.

Of course, as I mentioned in a previous post ("11.5 Things I'd Like to Learn at ePharma Summit"), most attendees of the ePharma Summit are looking for updates on FDA's guidelines for use of the Internet and social media by pharmaceutical companies; ie, Where are they? When are they? What are they?

From a preview of Abrams' Powerpoint presentation, it appears that he will have very little to say in answer to these questions. Only 3 out of 46 slides concern social media guidelines. Two slides merely summarize what we already know: how many people made presentations at the November 15, 2009 public hearing and how many comments FDA received to the public docket.

The third slide describes the FDA's guidance sausage-making process (shown below; click for enlarged view):

Again, nothing new: Abrams, for example, has said before that FDA will issue "multiple guidances." We are somewhere in the "Prepare a draft guidance document and vet through internal clearance process" stage; ie, the sausage is jammed in the machine.

Here's what I hope to ask Tom Abrams at the Summit (if he allows questions from the audience):

"Tom -- I hope I can call you 'Tom'; I've seen you at so many of these conferences that I feel we should be friends on Facebook or Twitter if not in real life, but I can't find you on these social networks, so maybe I should stick to Mr. Abrams: What's holding up the process of releasing SM guidance? For example:

• "Has President Obama's recent executive order for government agencies to review all regulations old and new to determine if they hinder economic growth thrown a monkey wrench into FDA's 'Social Media Guidance Process'? That is, is the FDA's guidance process slowed down because of this extra internal review that is required?

"Any comments at all about this issue that might be affecting the FDA's guidance process will be appreciated."

BTW, look for me wearing a special shirt, which may or may not be this one:

Scrooge FDA Delays Laying Social Media Guidelines Golden Egg: Why?

Scrooge FDA Delays Laying Social Media Guidelines Golden Egg: Why?

FDA's DDMAC is playing Scrooge to the drug industry's Tiny Tim this Christmas season and -- to mix metaphors -- won't be laying the golden goose egg everyone was expecting in 2010. The egg of which I am speaking, of course, is guidance for drug promotion via the Internet and social media.

According to a post over at EyeOnFDA, DDMAC issued this statement:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• On-line communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

I am not sure where this statement was made or to whom exactly, but I'll take it at face value.

This delay does not bode well for all of us expecting action from the FDA. With the new, Republican-controlled Congress coming into session next year, "Lame Duck" (or Cooked Goose) FDA officials are likely to be summoned before Senate and House committees to testify and to be grilled by Republicans. FDA may have to defend a lot of its recent regulatory actions. Obviously, Republicans favor less regulation and not more regulation. This may set the atmosphere within the FDA to be less vigilant regarding the regulation of drug advertising in general and Internet advertising in particular.

Also, political battles are likely to rage during the next Congress regarding recent online privacy initiatives by the FTC and the White House. The FDA may be caught up in these battles and be forced to be more cautious about issuing Internet guidelines. The announced delay may even be the first sign of caution. I note that the Center for Digital Democracy, for example, said FDA was incapable of policing privacy issues related to online health marketing (see "New Media Privacy Issues & Online Health Marketing").

Merck Says FDA Should Approve the “One-Click Rule”

Merck Says FDA Should Approve the “One-Click Rule”

Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads. For more background on the one-click rule, see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads."

When FDA issued those infamous 14 notice of violation letters last spring, the drug industry was stunned and immediately pulled back from branded search engine advertising (see "The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!"). Apparently, Merck revised its sponsored search ads to the help-seeking format “in March 2009 in response to DDMAC's enforcement letters on sponsored links.”

As a result, across several brands, Merck “observed an increase in click-thru rates with the unbranded, help-seeking format indicating that the format may have attracted more users seeking condition-specific information. However, the number of landing (product) site pages consumed after the click-thru consistently declined. For one brand, the number of page views by the searcher dropped by nearly 50%.”

Merck claims this "decrease in content consumption could indicate a lack of transparency between the advertisement and the linked to content” and “current unbranded, help-seeking sponsored links do not meet the needs of health information seekers using Internet search engines.”

I’m trying to understand Merck’s argument. This is the example “help-seeking” ad it presented in its comments to the FDA:

Merck did some market research to evaluate this and other ad formats, including this product-claim format that Google has made available to drug companies in beta tests (see "Is Google the New FDA?"):

Merck asked its study subjects “How do you feel about having to click on the link to gain access to the product safety information?”

For the Product Claim ad, 78% said they found it very or somewhat acceptable. For the Help-Seeking ad, however, only 34% said it was acceptable. Well, of course it’s not acceptable -- to get to the product information from the Help-Seeking ad, you first have to click through to the product web site. But this doesn’t mean that the Help-Seeking ad did not “meet the needs of health information seekers using Internet search engines.”

I think what Merck really means is that ITS needs are not being met by Help-Seeking ads!

Concluding its comments on the one-click rule for Product Claim ads, Merck says “the use of hyperlinks is an appropriate and effective way to disclose product use and safety information in limited space formats. FDA should adopt standards to be consistent with FTC guidelines and allow hyperlinks to fulfill the regulatory requirements for product use and safety information disclosures in digital media with space limitations, including but not limited to, banner advertising, mobile applications, text messaging and sponsored advertisements in search engines.”

AstraZeneca Urges FDA to Regulate the Whole and Nothing But the Whole SM Conversation

AstraZeneca Urges FDA to Regulate the Whole and Nothing But the Whole SM Conversation

AstraZeneca (AZ) submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

Again and again throughout its comments to the FDA, AstraZeneca defends the concept that social media conversations by drug companies are just like real world conversations and should be similarly regulated; ie, FDA should consider the whole conversation, not just one part of it.

"It is our view that the FDA, in developing its guidance, should view such participation in a manner analogous to its existing regulation of in person and telephonic promotional activities," said AZ. "In that case, the FDA examines not just one part of the conversation but the entire conversation as a whole."

"It is similarly appropriate for the agency to view a social media conversation as a whole and not regulate each and every 'post' as if it were, in itself, a promotional piece," said AZ in its comments where it cites FDA's draft guidance on risk communication. AZ quoted this precedent from the FDA guidance: "FDA looks not just at specific risk-related statements, but at the net impression – i.e., the message communicated by all elements of the piece as a whole. The purpose of the evaluation is to determine whether the piece as a whole conveys an accurate and nonmisleading impression of the benefits and risks of the promoted product." [FDA's words]

AZ takes this concept to new heights, however, when it attempts to include all sorts of things in the "conversation": "We recommend a framework that understands that a conversation may include text, video, sounds, and other elements that are appropriate to consider together." These elements, says AZ, can appear together or as near as together as the site or format allows.

AZ cites Twitter as an example: "... on Twitter or another micro-blogging site, a sponsor might use multiple, simultaneous 'posts' to convey information on risks and benefits including using links or other reference marks or symbols."

I once posted several tweets one after the other in an attempt to mimic a particular kind of conversation in the real world, ie, Burma-Shave roadside advertisements. You may be too young to remember this outdoor marketing trick. Typically, six consecutive small signs would be posted along the edge of a highway, spaced for sequential reading by passing motorists. The last sign was the name of the product (ie, "Burma-Shave"; see this wikipedia entry.) Here's an example (imagine each of the following phrases on a separate roadside sign separated by 100 feet or so):

That big blue tube


is like Louise


it gives a thrill


with every squeeze


Burma-Shave!

Each sign is part of the "conversation," but looked at in isolation it makes no sense.

BTW, my Twitter experiment was a disaster. No one strung the tweets together to get the entire message. I looked like a complete idiot who did not know how to use Twitter to communicate!

Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media

Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media

Pfizer submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

The world's #1 pharmaceutical company stands alone in calling upon the FDA to develop new regulations for the Internet and social media rather than issuing guidance that puts an "interpretative gloss" on existing rules.

"FDA should not try to fit the square peg of Internet and social media communications into the round hole of the Agency’s existing rules developed for conventional media," said Pfizer in its comments. "Rather, FDA should develop comprehensive new rules describing the actions manufacturers must take in order for their online communications to be truthful and non-misleading in the specific context of the online environment. The Agency should ultimately establish these new rules not in guidance -- which by definition cannot change existing rules but can merely provide an interpretive gloss on those rules -- but rather in new regulations. As discussed below, the public health would be benefitted by the establishment of binding, legally enforceable new rules that have been developed by FDA specifically for new media."

Pfizer contends that "for FDA to regulate in this sensitive area 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." Guidance, says Pfizer, is too vague and engenders "extensive litigation."

I don't know if that is a veiled threat or not, but Pfizer "believes it would be imprudent for FDA to repeat this pattern of seeking to address an entirely new field of conduct, where First Amendment rights are clearly at stake, without the discipline that comes with a rulemaking proceeding. Further, since the WLF litigation, the courts have only become more aggressive in policing FDA regulation of speech."

Ah Ha! WLF -- the Washington Legal Foundation, an organization "devoted to defending and promoting the principles of free enterprise and individual rights" (mostly for pharma companies) -- rears its head! I suspect, in fact, that the WLF wrote the first draft of Pfizer's comments or maybe it was Arnie Friede, former Pfizer Chief Counsel.

Pfizer predicts that vague guidance will inhibit companies from engaging in social media: "Many manufacturers simply will decide, as a risk management matter, that they will not engage, irrespective of any guidance from FDA, because the enforcement discretion reference means that the Agency regards that engagement as potentially violating a statutory or regulatory provision."

In other words, Pfizer believes guidance would stifle pharma's use of the Internet and social media rather than encourage it, which Pfizer implies should be the goal of FDA. "Such an approach [issuing guidance rather than new rules] would not be ideal, however, if FDA genuinely wants to encourage manufacturers to increase their level of engagement in online activities."

So the FDA is doomed if it does issue guidance and doomed if it doesn't. Either way, according to Pfizer, the FDA will stand in the way of free speech.