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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What happened to the Sun(shine)?

Two years ago, the Physician Payments Sunshine Provision was introduced in response to concerns that undisclosed financial relationships between Pharma and  physicians could unduly influence medical practice and patient care.

As part of the provision, all pharmaceutical companies are required to post payments to physicians of anything more than $10 on their web sites.

This law was based on the premise that transparency in these transactions is of public importance and that disclosure acts as a deterrent against quid pro quo exchanges. It was hoped that physicians would be more reluctant to accept large payments if they were publicly disclosed.  Ultimately it was hoped that such disclosure would bring transparency into the prescribing process.

So has this little ray of federal sunshine changed things?

In an attempt to gain insight, if not a definitive answer, a group of researchers examined a large database for prescription drug claims for statins and antidepressants that were written between July 2003 to March 2009 in a half dozen states, including Maine and West Virginia, which have their own sunshine laws.

In both states, brand-name and generic prescriptions were compared with two other states that do not have sunshine laws in order to determine the extent to which prescribing may reflect disclosure requirements. The analysis examined the change in prescribing, before and after their disclosure laws, and compared those results with the change in prescribing in comparison states over the same period.

The researchers postulated that a difference in prescribing in the disclosure state relative to comparison states would potentially reflect the impact of the disclosure law.

So what did they find?

Although there were some statistically significant differences between brand-name and generic prescribing for one or both types of drugs, overall, the effects were small to negligible.

In other words, there was minimal switching from brand-names to generics among two wildly popular therapeutic categories that were heavily promoted during the time period examined.

Why? The authors speculate that disclosure requirements did not capture all promotional spending by pharmaceutical companies and, while industry payments to physicians may have been disclosed to state agencies, the data may not have been disseminated sufficiently to the public to have an impact.

If the policymakers who passed these measures were hoping for a deterrent effect they may be disappointed,” said the study’s lead author, Genevieve Pham-Kanter, Ph.D., assistant professor in the Department of Health Systems, Management and Policy at the Colorado School of Public Health and research fellow at Harvard University and Massachusetts General Hospital.

Whether these results can or should be used by Pharma as an argument for scrapping the Sunshine Act remains to be seen.

Still, what the study demonstrates is that Congress and the Centers for Medicare and Medicaid Services (CMS) along with hundreds of pharmaceutical companies, will be paying hundreds of millions of dollars each year to implement a law that may not actually have its intended effect.

While transparency is an important goal, the administrative and financial burden have unintended knock-on consequences for Industry-funded research, education, and other scientific activities. , call into question.  America is currently facing a job crisis and has still not recovered from the economic decline.  The pharmaceutical industry provides a significant portion of new jobs and taxes that may help America out of these troubled times.

In light of this study, and the tremendous burdens the Sunshine Act imposes on the numerous stakeholders, Congress should perhaps reconsider the need for a federal sunshine law or come up with cheaper, less onerous alternatives.