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  • westley.prince westley.prince Sep 30, 2013 11:14 AM Flag

    Government Shutdown

    Will likely affect the FDA as well.

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    • With hope for congressional compromise waning by the hour, the federal government is bracing for its first shutdown in 17 years, and for the FDA, that means furloughing about half its staff and ditching duties it can no longer afford. What that spells for drug developers with eyes on approval, however, remains murky.

      If the government shuts down come Tuesday, the FDA will lose 6,620 employees, about 45% of its staff, and the agency would have to cease many inspections, enforcement actions and monitoring operations, also suspending the "majority" of its internal lab research, according to a Department of Health and Human Services briefing.

      As for advisory panels, PDUFA dates and the agency services that affect the drug development world, things are more opaque. While the government is quite clear that only mission-critical, life-and-death work will continue, DHHS also said that the "FDA would continue limited activities related to its user-fee funded programs," which would include drug approvals.

      Of course, the scope of the word "limited" remains unexplained, and the agency didn't respond to a voice message or email Monday.

      Next month alone, agency panels are slated to discuss an expanded indication for Amarin Pharmaceuticals' ($AMRN) much-scrutinized Vascepa and whether to approve Gilead Sciences' ($GILD) hepatitis C hopeful sofosbuvir. Postponing those meetings indefinitely would muddle launch timelines and rattle investor expectations, and a protracted shutdown would change the game for any drugmaker looking for near-term approvals.

      As for the the steady stream of regulations the agency normally churns out, Regulatory Focus points out that all government agencies have been instructed to publish only documents that support activities related to "imminent threats to the safety of human life or protection of property," which is to say the agency is unlikely to roll out any sweeping guidances with half its staff on a mandatory vacation.

 
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