Regulatory Focus™ > News Articles > Congress Releases Final Version of User Fee Bill, Shedding Controversial Provisions

Congress Releases Final Version of User Fee Bill, Shedding Controversial Provisions

Posted 19 June 2012 | By Alexander Gaffney, RAC 

Congressional negotiators have succeeded in merging together two largely similar user fee bills aimed at providing funding and reforms for the US Food and Drug Administration (FDA), leaving out many of the bill's most controversial provisions.

In a statement posted late on 18 June 2012, House Energy and Commerce Committee members said the merged bill, called the Food and Drug Administration Safety and Innovation Act (FDASIA), proves members of Congress can still work together "when it comes to critical life-and-death issues."

"I am proud that even during an election year, Congress is poised to carry out its most important function - passing bills that matter," Senator Mike Enzi, Ranking Member of the Senate Health, Education, Labor and Pensions Committee said.

The bill provides additional funding from industry in return for set performance goals by FDA, and also puts into place a number of reforms aimed at improving the agency and getting medicinal products to market more quickly.

Among the bill's most notable provisions: user fees will now cover biosimilars and generic drugs, medical device user fees will increase in return for faster reviews, Public Health Service workers will get additional whistleblowing protections, FDA will have more flexibility when reviewing orphan drug and device products, and antibiotic products will be given additional marketing incentives.

The provisions that did not make it into the bill are perhaps as notable as the ones that did. A long-debated drug tracking system known as a "track and trace" plan failed to make it into the final bill despite being included in the Senate version of the legislation, reports Reuters. Another provision aimed at preventing branded manufacturers from using a Risk Evaluation and Mitigation Strategy (REMS) plan to prevent potential generic competitors from obtaining their product was also left out after being subject to heavy lobbying pressure and questions regarding the provision's constitutionality. Controls on painkillers, too, failed to make it into the final bill, reports The New York Times.

The final bill now moves to separate votes in both the House and Senate, where they are expected to pass before being signed into law by President Barack Obama, who has expressed his support of the bill.


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Food and Drug Administration Safety and Innovation Act (FDASIA)


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