FDA’s TV Ad Review Is Unconstitutional, PhRMA Says, Or Maybe Should Be A Reg
A draft guidance that outlines six categories of drug ads FDA wants submitted for prior review is a violation of advertisers’ free speech rights, the industry group argues. Other comments float a storyboard compromise.
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FDA could be flooded with “millions of duplicative signatures” every time a health care practitioner requests a drug sample, the trade group warns.
Companies and other groups want clear FDA communication on biosimilars as pharmacists look for an Orange Book-like reference manual to be ready for prescriptions.
The agency’s draft guidance on prereview of television advertisements also requires companies to submit the information they rely on to support claims in an ad.