Lawmakers Push for Final Passage of PDUFA Reauthorization

The top Republican on the Senate Health, Education, Labor and Pensions (HELP) Committee has written the majority and minority leaders, encouraging them to appoint conferees to the committee that will finalize pending legislation reauthorizing the Prescription Drug User Fee Act (PDUFA) and enhancing the FDA’s drug safety efforts.

“Appointing conferees now would send a powerful message that Congress is working as hard as FDA is,” HELP Committee Ranking Member Mike Enzi (R-Wyo.) said in the July 27 letter. The Senate passed its version of the bill, S. 1082, in May, while the House passed its version, H.R. 2900, earlier this month. Since there are a number of differences, a conference committee made up of members of the House and Senate must reconcile the two bills before the legislation can be voted on again and sent to the president.

Members of the HELP Committee and their staffs are working on the bill, but the conference committee has not yet been assembled, a minority staff spokeswoman said.

In the letter sent to Majority Leader Harry Reid (D-Nev.) and Minority Leader Mitch McConnell (R-Ky.), Enzi warned that if PDUFA is not reauthorized before the Senate recess that begins Aug. 6, the FDA will have to send layoff notices to hundreds of agency employees, who could find jobs elsewhere. PDUFA expires Sept. 30.

More information on H.R. 2900 can be found at thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.02900:. S. 1082: can be found at thomas.loc.gov/cgi-bin/bdquery/z?d110:SN01082:.