Industry hit a record low number of FDA OPDP actions in 2015

Early-January information posted at FDA’s OPDP shows that only nine actions (warning letters or “untitled” letters indicating a violation) were issued in 2015 and, based on data compiled by the Regulatory Affairs Professionals Society,* that’s a record low number. OPDP actions have been declining since 2010, when they hit 51, and, dating back to the late 1990s, more than 100 such letters were being issued annually.

OPDP (formerly known as DDMAC, the Div. of Drug Marketing Advertising and Communications) reviews promotional materials and labels for marketed products “to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion,” according to OPDP descriptions. Particular enforcement bugaboos have been missing information on product risks, or making unsubstantiated claims about the product. OPDP’s charter has changed over the years; at present, it’s still trying to provide definitive guidance for online promotion, something that had much of the industry and its advertising agencies on their toes in the early 2010s. But the data might simply indicate that advertisers are much smarter about following existing guidance on promotion.

*http://www.raps.org/Regulatory-Focus/News/2016/01/19/23927/FDA-Promotional--Enforcement-Actions-Hit-Record-Low-in-2015