07.28.11

Enzi Supports Bipartisan Efforts On FDA User Fee Programs

WASHINGTON, D.C. – During a hearing today on the Food and Drug Administration’s (FDA) user fee programs, Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee, said that he supports bipartisan efforts to reauthorize the programs. 

“The prescription drug and medical device user fee programs have been a success, decreasing product review times over the long term, stabilizing funding for FDA’s drug and medical device centers, and decreasing the burden on taxpayers,” said Senator Enzi.  “I believe, however, that FDA can do better.  I have especially strong concerns about the device center’s performance. This is not a partisan political issue.  Democrats and Republicans, patient and consumer groups, industry, academics and other stakeholders have all raised concerns about the device center’s performance.  FDA itself has engaged in extensive self-scrutiny.”

Enzi said he and HELP Committee Chairman Harkin will work on one bill reauthorizing the drug and device user fee programs, authorizing new generic and biosimilar user fee programs, reauthorizing the pediatric drug testing laws, and making a small number of additional policy changes related to the FDA, potentially including supply chain integrity measures and measures related to the medical device review process.

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