What is the Prescription Drug User Fee Act: In a Nutshell

Jun 11, 2012 by Clinovo    No Comments    Posted under: Best-Practices

This article was reposted from Pharmaspective, a blog  from Porzio Pharmaceutical Services’ (PPS)

The Prescription Drug User Fee Act (PDUFA) was originally enacted in 1992, and authorizes the federal Food and Drug Administration (FDA) to collect fees from pharmaceutical companies seeking FDA approval of new drugs and biologics. In return for collecting fees, the PDUFA requires the FDA to meet performance benchmarks with the overall intention of making the New Drug Application review process more efficient. Since 1992, user fees collected by the FDA under the PDUFA have permitted the agency to expand its NDA review staff and considerably reduce a product’s review time while still assuring the safety of human drugs. Congress is required to reauthorize the PDUFA every 5 years by September 30th in order to ensure the continuity of the user fee programs.

To this end, the United States House of Representatives has introduced House Bill 5651, which would, among other things, reauthorize the PDUFA. House Bill 5651 also provides for the reauthorization of the Medical Device User Fee Act (MDUFA), which authorizes the FDA to collect fees from medical device manufacturers seeking its approval on new medical devices. Further, House Bill 5651 would authorize two new user fee programs: the Generic Drug User Fee Act (GDUFA) to facilitate the review process for generic drugs, and the Biosimilars User Fee Act (BSUFA) to facilitate the abbreviated review of products shown to be biosimilars to an FDA-approved biologic.

In an effort to reauthorize the PDUFA well before the September 30, 2012, deadline, House Bill 5651 has been moving quickly through the usual legislative hurdles. To date, both the House Energy and Commerce Subcommittee on Health, and the House Energy and Commerce Committee have unanimously approved the bill. House Bill 5651 will now move to the entire House for a vote.

Congress’ expediency in reviewing House Bill 5651 may be attributed to its desire to reauthorize the PDUFA well before the statutory deadline. The current version of the PDUFA was signed into law on September 27, 2007, just three days before the deadline. As the reauthorization deadline drew near without the PDUFA being reenacted, the FDA left many of its positions vacant in the event that that user fee charges were not available at beginning of the fiscal year on October 1, 2007. With thoughts of 2007 looming over their heads, supporters of the PDUFA are hoping to have House Bill 5651 enacted before the start of the upcoming fiscal year, which begins on October 1, 2012.

Ingrid Pelzer and Sheevani Patel

For more information on the PDUFA, please click on the following link: http://energycommerce.house.gov/news/PRArticle.aspx?NewsID=9507

UPDATE: Since this post was originally published, House Bill 5651 passed in the House and has been place on the U.S. Senate Legislative Calendar. The Senate’s version of PDUFA, Senate Bill 3187, was introduced on May 15, 2012, and passed in the Senate on May 24, 2012. Senate Bill 3187 has been sent to the House for consideration. Please note that Senate Bill 3187 is not identical to House Bill 5651.

Click on the following link for the current version of House Bill 5651: http://www.gpo.gov/fdsys/pkg/BILLS-112hr5651pcs/pdf/BILLS-112hr5651pcs.pdf

Click on the following link for the current version of 3187: http://www.gpo.gov/fdsys/pkg/BILLS-112s3187es/pdf/BILLS-112s3187es.pdf

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