Author: Mary Holloway
In November 2010 we reported on the FDA’s Bad Ad Program, which asks physicians to anonymously report misleading advertising and off-label promotion by pharmaceutical sales representatives. Last March, Doctor Directory, a leading market service company for the healthcare industry, conducted a survey to measure physicians’ attitudes toward the initiative. 90% of over 1,000 practicing physicians said that they would be at least “somewhat likely” to report questionable behavior. Now, just in time for the 1st anniversary of the Bad Ad Program, the FDA has released their results of the measure thus far.
Of 328 total complaints, 188 (57%) were submitted by healthcare professionals, 35% by consumers and 7% by representatives from regulated industry. 46% of all the complaints led to a comprehensive review.
As a result of these statistics, the FDA feels that they have been “successful in raising awareness” and that the healthcare community has a “strong level of knowledge” about unlawful promotion. The agency has vowed to expand its education to include students in medical, pharmacy and nursing schools while continuing their promotion of Bad Ad through the internet and at trade shows.
Some of the “bad ad” examples that garnered warning letters were cited in the report, including:
- A Hill Dermaceuticals website that misbranded their product by omitting or minimizing risk information, overstated efficacy, presented unsubstantiated superiority claims, broadened and inadequately communicated the indication and presented unsubstantiated claims for the product
- A Statgram communication from Three Rivers Pharmaceuticals that overstated efficacy among other violations
- Inappropriate statements made by a representative from Forest Labs
- A YouTube promotional video made by a Warner Chilcott sales representative
- A Shire promotional magnet that hid risk information (A business card obscured it)
The success of outside forces reporting unlawful promotion to the FDA coupled with the agency’s focus on prosecuting individuals clearly indicates that life-science companies need to ensure that the training that they provide covers both subtle cases of unlawful promotion and overall communication strategies.
- One-Stop Shopping for FDA Enforcement Actions (goodpromotionalpractices.com)
- Reporting and Abuse of FDA Bad Ad: Survey of 1000 Doctors (goodpromotionalpractices.com)
- The Good, the Bad and the Ugly–FDA Wants Your Help to Stop Bad Drug Ads (goodpromotionalpractices.com)