Washington Insider - Dec 2014

I come not to bury government but to praise it—at least the singular agency I know best: FDA

Washington Insider - Dec 2014
Washington Insider - Dec 2014

In the hyperactive political season just ended­—or, perhaps more accurately, just paused—dysfunctional government has been the focus of criticism bordering on hatred. But, astonished, I come not to bury government but to praise it—at least the singular agency I know best: FDA, for its eleventh-hour change of heart on how medical marketers can communicate on social media.

This came at the end of summer, when the agency reopened—on one unnamed party's request—the public comment period for an additional 30 days on two draft guidances, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

At the same time, it informally announced that it has relaxed its interpretation of drug-advertising reminder ads to allow “reminder-like” promotion on Internet/social media sites for drugs with boxed warnings in their labeling.

Traditionally, FDA has not allowed reminder ads for boxed-warning drugs. Now it says it will not object to them as long as they link to the package insert or brief summary.

Both of these steps show a surprising degree of resiliency and sensitivity. The agency's usually rigid and hidebound Office of Prescription Drug Promotion analyzes the modest total of 45 comments these documents had attracted by the time FDA decided to reopen the comment period.

A further indication of FDA's changed spirit was its response in June to a Medical Information Working Group petition, in which the agency indicated a refreshing new willingness to revisit its policies on the communication of new off-label uses for approved products.

Although there is much skepticism about the independence of FDA decision-making from political influences, I think these developments reflect credit on FDA and an abstention from political meddling on the part of its erstwhile puppeteers in the White House and HHS.

James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).


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