First Amendment Challenge To DTC Rule Unlikely From Industry; For Now, It Is 'Comply With Context'
DTC rule is a good fight to lose: it is a high-profile response to pricing, but will have a low impact – and is certainly a less painful solution than many of the alternatives.
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Nevertheless, the Pharmaceutical Research and Manufacturers of America announces enhancement of its drug pricing disclosures voluntary program, a Medicines Assistance Tool website that links to individual company sites, in response to the US rule.
From kinds of ads targeted to agency that's issuing the reg, policy seems designed to withstand a court challenge.
Internal review system reduces US FDA’s administrative work for OPQ risk assessments; agency’s standards will not change, and sponsors will not need to modify applications. Advisory committee endorses expansion, which will roll out to different application types over several years.