Biotech Values

[DewDiligence]

Congress Down to the Wire on PDUFA Reauthorization

http://www.fdalegislativewatch.com/2007/09/congress-down-t.html

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September 18, 2007
by Ingrid Mezo

FDA reform legislation reauthorizing device and drug user fees may not be finalized by Congress in time to avoid agency layoffs.

FDA says that if the House and Senate versions of the bill are not reconciled by Sept. 21, the agency would be forced to send out reduction-in-force notices to over 1,700 employees notifying them that they may lose their jobs due to insufficient funds. Both the device and drug user fee programs expire Sept. 30.

Staffers have been negotiating over differences between the FDA Amendments Act (H.R. 2900) and the FDA Revitalization Act (S. 1082) since the House passed its bill in July. However, a House-Senate conference committee had not been assembled as of Sept. 14.

Both bills allow FDA to collect $287 million in fees from device manufacturers over the next five years and in return commit the agency to meeting a new set of pre-market performance goals and a more interactive approach with industry when reviewing submissions.

The staff-level negotiations, however, have primarily focused on other provisions of the bill, including those relating to drug-safety monitoring and the establishment of a public drug and device clinical trial results database.

House Democrats say they are confident that a deal will be worked out in time, stressing that bipartisan negotiations are proceeding.

Senate Republicans have a different take on events. Sen. Mike Enzi, R-Wyo., ranking member of the Health, Education, Labor and Pensions Committee, blasted House Democrats in a Sept. 13 statement, calling on Congress to end "its foot dragging."

Enzi says that House Democrats have floated a proposal to temporarily extend the user fee programs by two or three months rather than sign off on the bills by Sept. 30. He said this is "not an option."

House Democratic staffers were evasive about having raised the possibility of temporary user fee extension.

"Speaker [Nancy] Pelosi has since made it clear that she is committed to continuing to work on this in a bipartisan way, and Senator Enzi appreciates that," an Enzi spokesperson said.

AdvaMed Senior Executive Vice President Amy Jensen Cunniffe and MDMA President Mark Leahy both expressed confidence that the bill would be passed in time for FDA to retain staff and said they were generally pleased at this point with language in the bill concerning devices, barring minor "tweaks."

However, "if we reach the point where we are past Sept. 21, I think that's where you'll start to see our members' concern level increase," Cunniffe said.

"It's in all of our interests to keep the really highly trained professionals at FDA in place so that the review times are not delayed further, but I would say that there have been commitments made around the table to FDA to get it done, and our hope and belief is that they will meet their deadline," she added.
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