Amy Dow, a Member of the Firm in the Health Care and Life Sciences practice, in the firm's Chicago office, and James Boiani, a Senior Counsel in the Health Care and Life Sciences practice, in the firm's Washington, DC, office, wrote an article titled "What You Need to Know to Keep Your Company's Promotions Out of the Enforcement Spotlight."
Following is an excerpt:
If you work in the pharmaceutical industry, you know that compliance with FDA rules on promotion is crucial to keeping your business in business. A mere allegation of non-compliance from FDA can have a profound impact on business, both directly (e.g., leading to a drop in sales or stock price) and indirectly (e.g., diverting precious resources to work on a response to the letter). In this article we explore recent FDA enforcement trends related to promotion of pharmaceutical products, and discuss the actions you can take to keep your promotion from getting your company the wrong kind of attention.
Through June 10, 2014, CDER's Office of Prescription Drug Promotion ("OPDP") has issued four untitled letters to pharmaceutical manufacturers in 2014 regarding promotional practices, all to smaller manufacturers. In each instance, the FDA alleged there was a misleading omission of risk information. Each of these letters also included allegations that the manufacturer had failed to disclose material limitations on the use of its drugs.
The good news for compliance professionals is that there has been a significant drop off in OPDP enforcement letter activity from 2013, when a total of 24 warning and untitled letters were issued, and a recent high of 50 letters issued in 2010. What explains this drop off in the number of letters issued and the focus on smaller companies?
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