Author: Dee Mahoney
The FDA launched a new program, Bad Ad, which is designed to educate health care providers about their role in ensuring that sales promotion by drug companies is truthful, and not misleading. The Bad Ad Program will help health care providers recognize misleading promotion and provide them with an easy way to report this activity to the FDA. The program specifically target sales reps’ pitches to health care providers, but medical professionals can also report false and misleading ads. DDMAC has created an email, BadAd@fda.hhs.gov, and toll free number where reports of potential violations may be reported anonymously.
The program will be rolled out in three phases:
In 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 will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1.
Sales professionals must ensure that they understand not only the blatant off-label promotion violations, but also the subtle off-label promotion violations. What sales professionals once considered “compare and win” or “guerrilla” selling may be considered misleading promotion in the eyes of the government. It is the responsibility of all sales professionals to ensure they understand the rules and laws that govern off-label promotion, especially as they pertain to their products.