Confusion over off-label marketing

Share this article:

Prominent Washington drug attorney John Fleder (Hyman, Phelps & McNamara) says that briefs filed in recent off-label marketing cases continue the confusion that exists in defining acceptable practices for drug and medical device companies.

Writing in his firm's FDA Law Blog, Fleder discusses some of the briefs filed in U.S. v Caronia, in which Caronia was convicted of conspiring to introduce misbranded drugs into interstate commerce because the drugs allegedly did not have adequate directions for use.

The Medical Information Working Group, composed of 11 major drug companies, argued that there is significant ambiguity regarding what speech is proscribed by the Federal Food, Drug, and Cosmetic Act, as construed and applied by FDA and the Justice Department.

In its brief, Fleder says, the government contends that in off-label cases, it uses off-label speech as mere evidence of the manufacturer's intent.

Fleder says this shows that the government is trying to stretch a “directions for use” theory to prosecute people for off-label use promotion because the law is silent on whether it prohibits off-label promotion.
Share this article:

Email Newsletters

More in Features

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...

Read the complete August 2014 Digital Edition

Read the complete August 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.