Competitors Are "Best Source" of Complaints About Promotions Received by FDA

Competitors Are "Best Source" of Complaints About Promotions Received by FDA

Approximately 12 minutes into yesterday's 45-minute "Bad Ad Program Webinar," Catherine Gray, PharmD, Management Advisor at DDMAC, got down to business and started talking about the program that some critics have said is "ineffective, not cost-effective, and biased" (see poll here). At that point, Gray talked about "Limitations" of FDA's drug promotion surveillance. She focused on promotions to physicians.

Among FDA's TOP three "normal" surveillance activities was "complaints submitted by industry competitors." In fact, Gray said "we have found that industry competitors tend to be some of the best sources of information about potentially false and misleading advertising."

I am not surprised that competitors complain to the FDA. I've spoken to industry people who read this blog because they like to see me blast their competitors. For example, when I speculated that Phil Mickelson was on the AMGEN/PFIZER payroll when he said glowing things about ENBREL in the press (see "Is Phil Mickelson Shilling for Enbrel?"), a competitor told me that his company wondered the same thing.

Of course, even competitors cannot hear what's said "behind closed doors" in physician offices, industry-sponsored dinner and lunch programs, and on the floor at major medical meetings. The FDA initiated its BadAd program to "fill these gaps" in its surveillance activities. Thus, the BadAd program is designed to solicit complaints from physicians about verbal statements made by company sales reps or company-paid speakers.

When asked "In cases where there is a complaint about an oral statement, what evidence standard do you use to go forward with an action," an FDA speaker responded: "We have a very high level of evidence that we require that often includes an affidavit ... and verification as well. So, we do have a very high ... standard of evidence that we require before taking enforcement action." No further details were given.

However, in response to another question, FDA said they also accept anonymous complaints, which obviously cannot be substantiated by an "affidavit." FDA does not reveal how many of the 239 BadAd complaints it received in 2010 were from "anonymous" sources, but given the fact that competitors are likely to be a major source of complaints, I image that a good deal of BadAd complaints are anonymous and likely to be worthless.

Of course, some companies are just too dumb not to leave a trail of verifiable evidence, such as Hill Dermaceuticals, which had a nice public website the FDA could plainly see violated its regulations (see FDA's Bad Ad Program is "Phoniest Thing Ever!" and screen shot below).

No wonder then that the Hill Dermaceuticals case was the ONLY BadAd complaint that resulted in a notice of violation letter. Does the FDA need a BadAd program for that? BTW, Jerry Roth, president of Hill Dermaceuticals, complained that DDMAC acted on a complaint filed by "a doctor for another [competing] company." Mr. Roth should THANK the FDA for giving his company some GREAT promotion!

Aside from violative verbal statements, the FDA's BadAd program is designed to capture complaints specifically about "Home-made promotional materials not submitted to FDA."

How rampant is the use of "home-made promotional materials" by pharma sales reps? It must be significant if the FDA specifically mentions it as a reason for the BadAd program, which don't forget, was created by "2 former sales representatives with 11 years combined selling experience." These former reps, said Gray, "are well aware what goes on behind closed doors." Perhaps these two former reps engaged in questionable promotion to physicians themselves? Gray added that they were "quite successful in selling their products."

My impression of the BadAd program is that it was created by former drug industry sales professionals and is designed to make it easier for sales reps and company-paid physicians to "rat out" their competitors, anonymously or not. It just doesn't present a good image of how a government agency should work. In fact, I am sure that under a new administration, the BadAd program will be the first item on the agenda for cutting. While it may be easy these days for a drug rep to begin a career in the FDA, I am not so sure a former drug rep FDA staffer will be able to get a job in the drug industry after being laid off due to budget cuts!

FDA's Proposed Web Study Will Further Delay Social Media Guidelines

FDA's Proposed Web Study Will Further Delay Social Media Guidelines

FDA has published in the Federal Register (click here) a series of proposed studies designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites.

This is BAD news for all us who have been waiting since November 2009 for the FDA to issues specific guidelines for use of the Internet and social media in promoting Rx drugs.

In its proposal (find my highlighted, annotated pdf version here), the FDA states:

"This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development [my emphasis]."

While it's interesting that the FDA now admits original regulations are not adequate in the "shifting dynamic" of today's Internet communication channels, FDA is essentially TABLING Internet guidance by proposing these studies. It's a classic bureaucratic delaying maneuver!

The first leg of the delay will be the 60 days beginning today necessary for the FDA to collect comments to its proposal via the Federal Register page linked to above. Then, FDA will have to review all comments regarding this proposal. Then, if FDA is not seriously challenged on the need for such studies (IS THERE REALLY A NEED?), it will implement the studies. After that it may or may not publish the results of the studies and Tom Abrams will go around the industry conference circuit presenting the results of the study while promising "to have these guidances out as soon as possible."

To which I say BULLSH*T!

Enough studies and hearings already!

I urge all who are interested to submit comments to the docket (here) and tell the FDA that these studies are NOT needed and that it should get off its ass and provide the industry with useful guidance.

P.S. Also, tell FDA it's time for Abrams to retire! (see "Is It Time for Abrams to Leave?").

YouTube Interruptus! Dear WhyInsulin: WHY the Dreadful LANTUS Safety Information Blue Screen and Voiceover?

YouTube Interruptus! Dear WhyInsulin: WHY the Dreadful LANTUS Safety Information Blue Screen and Voiceover?

DigiatlBulldog just tweeted this: "Breaking News: GoInsulin's YouTube replacement WhyInsulin is now live http://bit.ly/eDX0cT #socpharm"

The WhyInsulin Youtube Channel seems to be Sanofi-Aventis' latest venture into social media. Importantly, the site allows visitors to submit comments, which is rarely something pharma companies do.

I submitted this comment, which is "pending approval":

"Why was Shenee's video interrupted by the reading of the LANTUS safety information?"

What I was referring to was a dreadful blue screen and voiceover segment that abruptly ended Shenee's story. "Shenee is an active wife and mother who enjoys bowling, fishing, reading and cooking exotic foods with her husband." The blue screen, which began 55 seconds into the 3.04 minute video, merely showed a still text image (no scrolling or any movement at all) while a voiceover read the "Important Safety Information for Lantus" that was displayed on the YouTube page (see below).

I never did get to see what exotic foods Shenee was preparing! The blue screen completely took over the last 2 minutes and 9 seconds of the video!

The surprising thing is that Shenee NEVER mentioned LANTUS or any other treatment during her brief 55 second "story"! Which leads me to ask, Why was it necessary to interrupt her story with this information?

It just runied my whole experience with the site. I gave it a thumbs down. So far, there are 2 thumbs up and 2 thumbs down. What do you think?

Who Regulates Press Releases? The Case of Bayer's "Melt-in-Your-Mouth" Erectile Dysfunction Tweet

Who Regulates Press Releases? The Case of Bayer's "Melt-in-Your-Mouth" Erectile Dysfunction Tweet

Digital Pharma caught Bayer posting a Tweet - via its @BayerUKIreland Twitter account - that seems to violate new social media guidelines published by the UK's Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI).

Here's the Tweet stream that Digital Pharma preserved:

The tweet in question states "First and only melt-in-the-mouth erectile dysfunction (ED) treatment launches in the UK today." It includes a link to a LEVITRA BRANDED press release. I have preserved the press release as a PDF version (here) of the original Web version. I did this because Bayer might remove the original after it reads this post.

The PMCPA code states: "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."

As Digital Pharma points out, tweets are viewable by the general public and therefore cannot be "restricted to health professionals" as required by the PMCPA code: "The @BayerUKIreland account has about 500 followers, some are clearly members of the public, but many show no information as to followers’ location or occupation. As an open account all its tweets are on public display and indexed by search engines like Google."

BTW, I could NOT find the tweet by searching Google OR by examining the @BayerUKIreland Twitter stream. That's because Bayer DELETED the tweet according to Digital Pharma. This immediately raised red flags.

But does the Bayer tweet violate the PCMPA code?

In a previous post (see "Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster") I pointed out that Tweets such as the following from Boehringer Ingelheim (BI) may violate the PMCPA code:

The BI tweet mentions a BRAND name and its indication, but does not include fair balance information. The Bayer tweet, however, does NOT mention a brand name, just the indication and a benefit of a treatment (ie, "dissolves in the mouth in seconds, there’s no need to take it with water and it’s discreet").

Although the Bayer tweet does not mention a brand name, it may still be considered promotion of a drug in the UK. If so, does it violate the PMCPA code? According to Bayer, "Despite the recent publication of a discussion paper from the PMCPA, the position on use of social media and digital communication in relation to prescription medicines remains far from clear."

Bayer's Unregulated Press Release Posted via Twitter is NOT Balanced
Another issue that is FAR FROM CLEAR to me is how the Bayer PRESS RELEASE can pass regulatory muster in the UK. According to Digital Pharma, Andrea Postles (@AndreaPJPostles, LinkedIn public profile), PR & Media Relations Manager at Bayer UK, said: “We have sometimes ‘tweeted’ approved news releases where we know that the content, while of interest, is nevertheless non-promotional, and contains only factual and balanced information."

To which I say BULLSH*T! You can read the "approved" press release here. It is clearly NOT "non-promotional" as Ms. Postles claims.

For example, the first paragraph of the press release states: "Today marks the launch of the first ED treatment available as an orodispersible tablet. In contrast to other drugs of the same class, the new formulation has been designed specifically to be discreet and convenient, has a minty flavour and dissolves on the tongue within seconds."

Here's another example of promotional language found in the second paragraph of the press release: "Levitra orodispersible was developed to help remove the known barriers associated with erectile dysfunction medication by providing men with a more convenient and discreet treatment option which may also help to lessen the embarrassment surrounding the condition."

I'm sold! Where do I get it?

OK, so the press release IS promotional. It mentions the brand name and benefits. But shouldn't it also mention possible side effects and safety information -- ie, the fair balance? Contrary to what Ms. Postles says, the press release does NOT contain "balanced information." There is NO mention of any possible side effects, other treatment options, risks, etc. It's all about LEVITRA and its benefits.

Most pharma product-specific press releases I have seen have a section entitled something like "IMPORTANT SAFETY INFORMATION." The Bayer press release has NO such section. How can it be called balanced?

The importance of PR as a marketing tool has increased DRAMATICALLY, IMHO, with the ascendancy of Twitter and other social media applications.  Pharma corporate communications people seem to be taking a leading role in using social media to promote products while claiming what they do is NOT marketing or promotional. This is a hot topic that I will explore with colleagues in tonight's #socpharm chat at 8 PM Eastern. Join us!

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P.S. @Alex__Butler tweeted this: "@pharmaguy on the broad point of press materials they are public and covered by the code/clause 22; http://t.co/U9FM6UC" which links to the 2011 version of the ABPI Code of Practice for the Pharmaceutical Industry (here). Clause 22.2 states:

"Information about prescription only medicines which is made available to the public either directly or indirectly [my emphasis] must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.

"Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine."

A press release is information that is intended for journalists with the intent that they will write a story about the information in the press release. Thus, the Bayer press release was made available "indirectly" to the public -- and even directly because of the Tweet linking to the press release.

The press release is "misleading about the safety of the product" because it contains NO SAFETY INFORMATION whatsoever!

Although the press release does NOT directly "encourage members of the public to ask their health professional to prescribe a specific prescription only medicine," the benefit statements made in the press release are simple for the average Joe (or Nigel) to understand and certainly aim to encourage the public to get a prescription of this product.