In May 2010 SRxA’s Word on Health broke the news about the FDA’s Bad Ad Program. As you will recall, this initiative asked physicians to anonymously report misleading advertising and off-label promotion by pharmaceutical sales representatives.
At that time, Doctor Directory, a leading market service company for the healthcare industry, conducted a survey to measure physicians’ attitudes toward the initiative. The results showed that 90% of practicing physicians said that they would be at least “somewhat likely” to report questionable behavior.
Now, to mark the 1st anniversary of the Bad Ad Program, the FDA has released their results of the measure thus far.
Of 328 total complaints, 57% were submitted by healthcare professionals, 35% by consumers and 7% by representatives from the industry itself. Almost half of all the complaints led to a comprehensive review.
Based upon 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. Nevertheless, the agency has vowed to expand its education about the program to include students in medical, pharmacy and nursing schools.
Some of the “bad ad” examples that resulted in warning letters included:
- 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 communication from Three Rivers Pharmaceuticals that overstated efficacy
- 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
These results, coupled with the agency’s focus on prosecuting individuals, as reported by us last week, clearly indicates that pharma and device companies need to ensure that their promotional and educational vendors are not only fully in tune with the regulations, but one step ahead.
To learn more about SRxA’s compliant and successful programming, contact us today.
SRxA's Word on Health 