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.
The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”