The US Food and Drug Administration’s scrutiny of product promotions online

Authors: Cori Annapolen Goldberg, Chaula B. Mehta, Krishna Kavi Publication | February 3, 2017

Social media is where it’s at. These days, millennials seem to communicate primarily online, and various popular apps have consumers of all ages glued to their screens. It’s no surprise, then, that pharma and medical device companies have increasingly been turning to social media and other online platforms to market their products. But with a platform that reaches the hands of so many so instantly, how do companies ensure that their posts are compliant with regulations? In June 2014, after years of issuing individual Warning and Untitled Letters to various manufacturers, packers, and distributors, the FDA published draft guidance regarding the use of social media to promote prescription drugs and medical devices. Throughout 2016, and especially at the end of the year, the FDA’s Office of Prescription Drug Promotion (‘OPDP’) focused its enforcement on such marketing efforts, thus necessitating an organised, thoughtful approach by those drug companies that wish to capitalise on the popularity of social media to inform consumers about their products. While the OPDP focuses on drug promotion, medical device manufacturers should consider these concerns and risks as well as acknowledging that they are not immune to enforcement efforts.

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Contacts

Cori Annapolen Goldberg

Cori Annapolen Goldberg

New York Washington, DC
Chaula B.  Mehta

Chaula B. Mehta

Washington, DC
Krishna Kavi

Krishna Kavi

Washington, DC