FDA program to ensure prescription drug advertising, promotion not misleading

The FDA introduced today a new outreach program — the Bad Ad Program — designed to inform health care professionals about efforts to help the FDA ensure that prescription drug advertising and promotion is truthful and not misleading.

“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” Thomas Abrams, director of the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the FDA’s Center for Drug Evaluation and Research, said in a press release.

The program will help health care professionals to better understand what constitutes appropriate prescription drug promotion and advertising, and how to report possible violations. It will also seek to increase the effectiveness of DDMAC’s surveillance program; examples include curtailing inappropriate promotional activities of sales representatives visiting physicians’ offices and delivering presentations to health care professionals during industry-sponsored dinner and speaker presentations.

The program will be introduced in three phases:

Phase 1: DDMAC will engage health care providers at specifically selected medical conventions and partner with specific medical societies to distribute educational materials.
Phases 2 and 3: Expand on the FDA’s collaborative efforts and update the educational materials developed for Phase 1.

Although the FDA’s traditional regulatory efforts for monitoring prescription drug promotion have been effective, the agency has limited ability to monitor promotional activities that occur in private.

According to a recent Congressional Budget Office brief, promotional spending on sales promotion to health care professionals outpaces direct-to-consumer spending by almost three to one. The FDA said it hopes that the Bad Ad Program will provide a valuable opportunity for the agency to increase surveillance efforts in the largest area of prescription drug promotion.

The DDMAC will exhibit at some of the major medical conferences this month, in which reviewers will present information on how to recognize misleading prescription drug promotion and how to report any potential violations to the FDA.

In the meantime, health care professionals are encouraged to report a potential violation in drug promotion by sending an e-mail to badad@fda.gov or calling 877-RX-DDMAC. Reports can be submitted anonymously; however, the FDA encourages providers to include contact information so that DDMAC officials can follow-up, if necessary.

The Bad Ad Program is intended to engage health care professionals in identifying and curbing misleading promotional advertising related to prescription drugs. This is an important issue for our profession to address, and an ethical responsibility of all healthcare providers. Advertising related to prescription drugs, whether aimed at providers or patients, can and should play an important role in educating providers and patients regarding the risks and benefits of these important innovations. However, the source and accuracy of the information should be vetted and confirmed, and the Bad Ad Program provides health care professionals an opportunity to play an essential role in that process. By working together with policymakers, patient advocacy groups and the pharmaceutical industry, we can help ensure that the information we distribute regarding prescription drugs is accurate, up-to-date and helpful in informing shared decisions between physicians and their patients regarding the use of prescription drugs.

– Kevin J. Bozic, MD, MBA
Associate professor, Residence UCSF Department of Orthopaedic Surgery

Philip R. Lee Institute for Health Policy Studies, San Francisco, Calif.

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