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Congressman Gene Green

Representing the 29th District of Texas

Rep. Gene Green Legislation Passes House of Representatives

July 12, 2017
Press Release
Reauthorizes FDA User Fee Agreements

WASHINGTON, DC Today, the House of Representatives passed by voice vote H.R. 2430, the FDA Reauthorization Act of 2017. As the Ranking Member of the Energy and Commerce Subcommittee on Health, Congressman Green has worked on a bipartisan basis to pass a package of user fee agreements that will reauthorize key FDA capabilities to review and evaluate medical devices, brand and generic drugs, and biosimilar products.

It is critical that these programs be reauthorized in a timely manner. Failure to do so would derail clinical trials, grind research to a halt, and put the new therapy pipeline in jeopardy. Much progress has been made since the first user fee agreement was made in 1992, and I’m pleased we are advancing these reauthorizations,” said Green.

Although the current five-year FDA user fee agreements do not expire until September 30, 2017, the FDA would be forced to send layoff notices to more than 5,000 employees if the agreements are not authorized before the August work period.

“FDA approval is the global gold standard, and reauthorizing the user fee programs will ensure the agency has the resources – particularly capable, qualified staffers – to fulfill its mission,” said Green.

H.R. 2430 includes additional provisions beyond the underlying agreements that are worthy of support. It will promote generic drug development and competition, establish a category of over-the-counter hearing aid, crack down on counterfeit drugs, and foster innovation in medical imaging.

A copy of the legislation can be read HERE.