FDA Reauthorization Bill Approved By the House

Last week, the House of Representatives approved bipartisan legislation to reauthorize industry user fee programs to provide addition funds for the U.S. Food and Drug Administration’s (FDA’s) drug and medical device approval process.

The legislation, H.R. 2430, the Food and Drug Administration Reauthorization Act, is supported by the pharmaceutical and medical device industries, and is similar to legislation passed by the Senate HELP committee last month.

The House and Senate are expected to reconcile their two versions of the bill, sending it to the President before the user fee programs expire at the end of September. Included in the legislation is an amendment aimed at promoting the development, and lowering the price, of new generic drugs.

The amendment, sponsored by Rep. Gus Bilirakis (R-FL), would require the FDA to prioritize the approval of generics within eight months when there are three or less generics drugs on the market; create a program to have the FDA work with drug manufacturers to improve the quality of submissions, so more applications can be approved the first time around; give the FDA tools to maintain an accurate list of drugs with little or no competition; and, provide an incentive for drug manufacturers to enter markets where only one or no generic drug exists.