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FDA User Fee Program Reauthorization Advances in Senate

May 25, 2012

FDA User Fee Program Reauthorization Advances in Senate

In this Congress, passage of a bill by a strong bipartisan vote is usually a "man bites dog" story. That happened yesterday when the Senate passed legislation to reauthorize the Food and Drug Administration's user fee program for the review process for prescription drugs and medical devices. The bill, The Food and Drug Administration Safety and Innovation Act (S. 3187), was adopted on a 96-1 vote. The user fee program is commonly referred to as PDUFA after the original 1992 bill, the Prescription Drug User Fee Act. It has been reauthorized three times, for five year periods. Under the program, the FDA collects fees from companies seeking approval of prescription drugs and biological products. The fees are used to support a streamlined review/approval process for new prescription drugs and biologics without sacrificing drug safety. This is of enormous importance to people living with HIV/AIDS and other chronic diseases who benefit from a quicker approval of needed drugs.

Senator Bernie Sanders (I-VT) cast the dissenting vote. Senators Richard Blumenthal (D-CT), Kay Bailey Hutchison (R-TX), and Mark Kirk (R-IL) did not vote. A number of amendments were considered but most were defeated. Most notable was an amendment offered by Senator John McCain (R-AZ) that would have allowed importation of drugs from Canada. A few amendments related to FDA processes were adopted.

The House version of PDUFA reauthorization is the Food and Drug Administration Reform Act of 2012 (H.R. 5651). The House is expected to take up its bill after the Memorial Day recess. Both chambers hope to send a final bill to the President by early July. The current reauthorization period ends Sept. 30, 2012.

AIDS United strongly supports reauthorization of PDUFA under a "clean" bill, without extraneous amendments. Click here is read AU's letter to the Senate.

Click here for information on PDUFA.

For an earlier blog on PDUFA reauthorization click here.

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This article was provided by AIDS United. Visit AIDS United's website to find out more about their activities and publications.
See Also
National HIV/AIDS Strategy for the United States: Executive Summary
U.S. Announces First National HIV/AIDS Strategy
More on U.S. HIV/AIDS Policy
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