Monday, June 13, 2011

The FDA's "Bad Ad" Program Turns 1; Looks To Expand Into The Future

The FDA launched the "Bad Ad" Program — to inform HCPs about what constitutes misleading promotion (from both a legal and clinical perspective) and provide them an easy process for reporting suspected violations to FDA — in May 2011. Since then the FDA has received 328 reports of potentially untruthful or misleading promotion, a 300% increase from the previous year's reports. From the 328 reports, 188 were submitted by HCPs, 116 were submitted by consumers, and 24 were submitted by representatives of regulated industry. Out of these submissions approximately 47% of HCPs submissions, 21% of consumers submissions and 58% of the representatives submissions were identified for comprehensive reviews. While the FDA released the figures for submissions that qualified for reviews, they did not release the figures for how many of these reviews resulted in warning letters.

According to the FDA, these results demonstrate the success of the Bad Ad Program in heightening "the awareness of misleading promotion among HCPs throughout the health care community" and the "likely useful deterrent this awareness has on drug promoters who might run afoul of regulation absent of such messaging."

As planned, The FDA will make improvements to the program based on Phase 1 learnings and will expand upon the Bad Ad Program to include: a web-based continuing education program; additional efforts on students and early career HCPs; collaborating with the nation’s medical, pharmacy, and nursing schools to enhance student education; presenting at U.S. teaching hospitals and continuing the attendance of DDMAC representatives at trade shows across the country.

Implications and Action Items
Our recommendation for pharmaceutical marketers is 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

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