Vital Signs

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Shutdown won't stop FDA advisory meetings

By Jaimy Lee

The government shutdown isn't stopping Food and Drug Administration advisory committee meetings scheduled this month, according to drug and device manufacturers.

Some analysts warned that the shutdown could limit the FDA's panel discussions, postpone meetings and ultimately delay product launches and spook investors.

The FDA retained about half its staff during the shutdown and the majority of those staffers have jobs that are funded by user fees paid by drug and device companies in exchange for performance goals. Most of the shutdown's impact on the agency affects its food safety, nutrition and cosmetics activities, the FDA has said.

“Since the underlying activities and staff are paid for by a combination of user fees and appropriated funds, it is too early to predict the priorities and achievable workload of the retained staff,” the Alliance for a Stronger FDA, a group that advocates for FDA resources, said in a statement last week.

There are nine advisory committee meetings scheduled in October.

This week, an FDA advisory committee is expected to vote whether to expand indications for Medtronic's cardiac resynchronization therapy pacemaker and cardiac resynchronization therapy defibrillator devices. The committee is also expected to vote on the pre-market approval application for a heart-failure monitoring system developed by CardioMEMS, an Atlanta-based device manufacturer.

Robert Littlefield, a GlobalData analyst, said in an Oct. 4 news release that he expected the stalemate in Washington would mean the meetings would “hamper approval efforts or delay the meetings altogether, which would push back authorization of the expanded indications for Medtronic's CRT devices.”

Not so, says Medtronic. In an e-mail, a Medtronic spokeswoman said the Oct. 8 meeting would proceed as planned.

And Amarin Corp., a Bedminster, N.J.-based biopharmaceutical company, says in a statement on its website that its advisory committee meeting remains scheduled for Oct. 16 “despite the current federal government lapse in appropriations.”

Follow Jaimy Lee on Twitter: @MHjlee


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