FDA ups the Ante on Pharma Ads

bad ad cme courseAs the feds continue to crack down on pharma marketing infractions the FDA has upped its own stake in making sure advertisers play by the rules. The agency has just launched an e-learning course aimed at healthcare providers to teach them how to spot and report misleading or untruthful drug ads, or promotional activities.

The multi-module, multi-media  course, launched in conjunction with MedScape, uses case studies to help HCP’s “become more discerning readers of drug promotional information,” according to Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion.

bad ad course screen shotThe course is part of Bad Ad, a program the agency designed in 2010 to educate doctors about their role in ensuring advertising stays honest. And to incentivize doctors to take the course they are offering Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs.

The FDA estimates that there are more than 80,000 unique new pieces of promotional literature produced each year, including journal ads, sales aids and e-detailing pieces.  In addition, there are approximately 80,000 pharmaceutical sales reps working in the field. Assuming each one makes 8-10 calls per day and presents 1-3 products during every call, that adds up to between 166 and 624 million opportunities to breach promotional guidelines.

Over the past decade, drug-makers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. Click on the links below for details of the biggest 11 settlements in recent years:

Back when the FDA was rolling out the Bad Ad program, the agency drew fire from marketing execs for encouraging physicians and other providers to report false advertising  – and for allowing them to do so anonymously. They accused the agency of deputizing doctors rather than hiring the staff necessary to review advertising internally.

Even so, many states have taken their own steps to combat misleading materials through “academic detailing,” where physicians, pharmacists, nurses and other trained medical reps spread info about prescription drugs. The goal is to improve quality of care and reduce healthcare spending. Advocates of academic detailing say that educating prescribers about all treatment options – not just the new, expensive ones – could help them make informed decisions that could, in turn, bring down drug costs.

Bad Ad brochure Pharma sales and marketing folks take note.  Between these federal and state initiatives, the potential for falling foul of the guidance just increased.

And yes, in case you’re wondering I did take, and pass, the course as part of my research for this blog post.

Contact us today, to find out how SRxA can help you with compliant pharma promotion.

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Watch Out – the FDA’s About!

It’s been a busy year for the FDA.  In addition to approving 63 new and original drug applications (NDA’s and BLA’s)  since the beginning of 2010, the Agency has rejected countless more, including the much touted “pink pill” or Female Viagra and the fat fighting drug Qnexa.

They also appear to have taken on the pharmaceutical industry – in a big way.

Industry insiders and observers are all acutely aware of the increase in the number of Warning Letters and Notice of Violation letters coming out of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC).

Since January 2010, DDMAC has issued 71 warning letters, notifying pharmaceutical companies about promotional violations. The number has been steadily rising since 2009.

Word on Health suspects that this may, in part, be due to the fact that the FDA recently reversed a policy that required warning letters to undergo legal review before they were issued. Then again, maybe the Agency’s BadAd program is bringing more promotional “no-no’s” to their attention.

Others would like to blame social media and the lack of FDA guidance for the increase. Indeed, just last week the FDA issued a Notice of Violation letter regarding the “Share” function on Facebook.  It’s also rumored that DDMAC has staffed up.

Whatever the reason, it means the pharmaceutical industry needs to be more careful than ever.

SRxA can help companies develop and deliver, compliant and effect programs. Contact us today to learn how we can help you avoid becoming another FDA statistic.