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U.S. Government Shutdown Could Postpone FDA Advisory Panels

WASHINGTON D.C. ( TheStreet) -- Advisory committee meetings scheduled for October by the U.S. Food and Drug Administration to review drugs from Amarin (AMRN), Johnson & Johnson (JNJ - Get Report) and Gilead Sciences (GILD - Get Report) might be postponed or cancelled if the political stalemate over the U.S. budget and debt-ceiling limit leads to a government shutdown.

Unless Republicans and Democrats in Congress reach an agreement, the U.S. government shuts down on Oct. 1. Thousands of public employees will be furloughed and all non-essential government functions halted.

Details about specific FDA operations that would remain open for business or go dark aren't being disclosed right now, according to an agency spokesperson, referring questions to the White House's Office of Management and Budget.

However, if current FDA contingency plans are similar to those readied back in 2011 when the last budget impasse threatened to shutter the U.S. government, ongoing drug reviews and advisory committee meetings would be put on hold or postponed.

As it stands, an FDA expert panel is scheduled to review Amarin's Vascepa on Oct. 16. A different two-day FDA panel beginning on Oct. 24 is set to review hepatitis C drugs from Johnson & Johnson and Gilead Sciences.

There may be no need to postpone these FDA advisory panels if the U.S. government is shuttered for only a few days. If the budget and debt-ceiling impasse is extended, all bets are off.

Amarin doesn't expect the Vascepa panel to be affected by a government shutdown, according to a statement posted to its web site.

Here's the statement from OMB Press Secretary Emily Cain, in response to a question about what happens to the FDA in the event of a government shutdown. (She doesn't answer the question.)

The Administration strongly believes that a lapse in appropriations should not occur. There is enough time for Congress to prevent a lapse in appropriations, and the Administration is willing to work with Congress to enact a short-term continuing resolution to fund critical Government operations and allow Congress the time to complete the full year 2014 appropriations.

However, at this time, prudent management requires that the government plan for the possibility of a lapse and OMB is working with agencies to take appropriate action. This includes agencies reviewing relevant legal requirements and updating their plans for executing an orderly shutdown, as outlined in the guidance OMB issued last week. This planning is consistent with what was done in previous instances where a potential lapse in appropriations was approaching.  

It is our hope that this work will ultimately be unnecessary and that there will be no lapse in appropriations.  

Agencies are still in the process of reviewing relevant legal requirements and updating their plans. Determinations about specific programs are being actively reviewed as agencies undertake this process.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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