RTCRM

On May 11, 2010, the U.S. Food and Drug Administration (FDA) launched the first stage of an educational outreach program aimed at enlisting healthcare providers (HCPs) in the monitoring and reporting of misleading prescription drug advertising. The “Bad Ad Program” will be administered by the Division of Drug Marketing, Advertising, and Communications (DDMAC) and will be rolled out in three phases.

The FDA currently oversees prescription drug advertising by reviewing ads submitted by drug companies, investigating industry/consumer complaints about promotional materials, and monitoring pharmaceutical industry events. However, with limited staffing resources, the FDA and DDMAC are unable to analyze and evaluate every prescription drug–related advertisement.

To address this gap in DDMAC’s monitoring abilities, the Bad Ad Program aims to educate HCPs on current DDMAC prescription drug promotion guidelines, teach them how to recognize common pharmaceutical advertising missteps, and provide them with an easy, potentially anonymous, method for reporting possible violations.

Of particular note is the Bad Ad Program’s specific goal of enlisting the help of HCPs in curtailing and reporting potentially inappropriate promotional activities: 1) by sales representatives during office visits; and 2) at promotional presentations during industry-sponsored dinners and speaking engagements. This area of prescription drug advertising has seen increased scrutiny in 2010, with the FDA and DDMAC issuing warning letters (http://tiny.cc/mnotz, http://tiny.cc/hgi1k, http://tiny.cc/5yfgx, etc.) citing both printed sales materials and oral statements made by pharmaceutical executives at industry conferences.

According to a May 11, 2010, FDA press release, the program will consist of three phases. Phase 1 focuses on educating healthcare professionals at select medical conventions, with DDMAC disseminating educational materials through partnerships with a select group of medical societies. In Phases 2 and 3, the FDA will refine the educational materials from Phase 1 and continue to develop outreach partnerships efforts. DDMAC plans to kick off the Bad Ad Program at major medical conferences starting in May 2010.

Implications and Action Items

Pharmaceutical marketers should continue to adhere to DDMAC guidelines when developing all prescription drug advertising regardless of medium or target audience; this includes digital promotions and unbranded websites.

With regard to current in-market promotions, marketers should:

• Ensure all branded or unbranded promotional and sales materials:
  • Are accurate
  • Balance the risk and benefit information
  • Are consistent with the prescribing information approved by the FDA
  • Only include information that is supported by strong clinical studies

• Review all branded or unbranded promotion and sales materials and remedy any of the following:
  • Omission or downplaying of risks
  • Overstatements of effectiveness
  • Promotions of off-label or unapproved uses
  • Misleading drug comparisons

To review the Key Points of FDA Healthcare Professional Outreach (Bad Ad Program), please visit http://tiny.cc/badadprogram. For more reviews on FDA guidelines, please visit http://www.rtcrm.com/whitepapers and http://www.rtcrm.com/blogs. FDA warning letters and FDA guidelines can be found at http://www.fda.gov.