BioCentury
ARTICLE | Politics & Policy

Industry petitions FDA against new standard for intended use

February 10, 2017 12:04 AM UTC

In a Citizen's Petition, PhRMA, BIO and the Medical Information Working Group (MIWG) asked FDA not to implement a new rule that they said could expose drug manufacturers to legal jeopardy related to off-label use of therapeutics. The groups asked FDA to revert to an earlier proposed rule that used a narrower definition of a drug's intended use, which would prevent companies from being prosecuted based on their knowledge of off-label use.

Last month, FDA published a final rule that revised the definition of "intended use" to include a "totality of the evidence" standard, which the petitioners said would allow FDA to consider any information as evidence of a product's intended use -- including knowledge of its off-label use. They argued that the standard would allow a prosecutor to consider elements such as production scale-ups or scientific exchange about off-label use as evidence of intended use in a unapproved indication...