PDUFA Reauthorization Bill Unlikely To Move To Conference Committee Before August Recess

Main Category: Pharma Industry / Biotech Industry
Also Included In: Medicare / Medicaid / SCHIP;  Public Health
Article Date: 07 Aug 2007 - 16:00 PST

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A bill that would reauthorize the Prescription Drug User Fee Act, which expires on Sept. 30, and expand FDA oversight of prescription drug safety likely will not move to conference committee before the August recess after House and Senate staff ended negotiations without an agreement, according to CQ Today. The House version of the legislation contains stronger prescription drug safety provisions than the Senate version, and the Senate version includes a provision not included in the House version that would allow FDA to approve generic versions of biotechnology medications.

In a statement, Sen. Mike Enzi (R-Wyo.) said that negotiations on the legislation between House and Senate staff have ended and that House Democrats have focused on legislation to reauthorize and expand SCHIP, rather than the legislation to reauthorize PDUFA (Armstrong, CQ Today, 8/2).

FDA To Use Reserve Funds To Avoid Layoff Notices
In related news, FDA Commissioner Andrew von Eschenbach on Thursday said that the agency will use reserve funds to maintain agency operations to avoid the need to distribute layoff notices to employees in advance of the expiration of PDUFA (Edney, CongressDaily, 8/2). FDA would have had to distribute the layoff notices in the event that lawmakers did not complete the legislation to reauthorize PDUFA before the August recess.

In a letter to Senate leaders last week, Enzi raised concerns that the layoff notices would prompt FDA employees to seek other jobs. House Chief Deputy Minority Whip Eric Cantor (R-Va.) has raised similar concerns. Democrats have indicated they are not concerned about the layoff notices because they believe FDA employees will ignore them with the legislation near finalization (Kaiser Daily Health Policy Report, 8/1).

Von Eschenbach said, "We won't let anybody go, but it really creates a problem with bringing anybody on." He added that FDA will not hire new employees (CongressDaily, 8/2). In addition, he said that the uncertainty about finalization of the legislation has affected the morale of agency employees, 30% of whom have reached retirement age (Reichard, CQ HealthBeat, 8/2).

Opinion Piece
Lawmakers "have a key role to play in making our medical products safer, or not," based on whether they pass the legislation, Susan Wood, a former assistant commissioner for women's health at FDA, and David Michaels -- a former assistant secretary of energy for environment, safety and health -- write in a Boston Globe opinion piece. Wood and Michaels write, "What they decide before their August recess has the power to save lives and to strengthen the FDA through a new focus on safety, scientific transparency and adequate funding -- or to allow the unacceptable status quo to continue" (Wood/Michaels, Boston Globe, 8/1).

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