'Right To Try' Or 'Right To Ask'? Hearing Spotlights Adverse Events As Key Barrier To Expanded Access
FDA and the pharmaceutical industry appear to have a shared interest in finding ways to dramatically increase expanded access programs to avoid a potentially difficult fight over 'Right to Try' legislation at the federal level in 2017. A September 22 hearing on a pending Senate bill illustrates why.
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US FDA’s updated Q&A guidance on Expanded Access places greater emphasis on safeguards around emergency use and Treatment IND programs – a change in tone from the version finalized during the ‘Right To Try’ debate.
New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.
Heading into the user fee reauthorization cycle, it seems inevitable that some form of federal 'right to try' legislation will tag-along for the ride. The recently departed head of the Office of New Drugs is among those who thinks the innocuous-sounding bill is a very bad idea.