Healthcare Business News

Obama signs bill amending FDA user-fee law

By Jaimy Lee
Posted: October 6, 2012 - 12:01 am ET

President Barack Obama signed legislation that will amend the Food and Drug Administration's user-fee law to ensure that a new program intended to improve approval times for generic drugs can begin.

The FDA User Fee Correction Act, which was passed by the House and Senate last month before Congress adjourned, addresses the industry's concern that the government's temporary funding measure would delay implementation of the generic user-fee program.

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The FDA collects millions of dollars in user fees from the pharmaceutical and medical device industries each year in exchange for using the funding to improve the drug and device approval process.

Earlier this year, lawmakers reauthorized the pharmaceutical and device user-fee agreements and authorized new user-fee programs for the generic-drug and biosimilars sectors under the Food and Drug Administration Safety and Innovation Act.

The user fees are expected to be part of the sequester cuts, according to the Alliance for a Stronger FDA, an advocacy group that advocates for FDA resources.

In a statement released in September when lawmakers passed the legislation, the Generic Pharmaceutical Association President and CEO Ralph Neas applauded the change.

“For consumers to fully benefit from the savings offered by generic medicines, it is critical that the FDA have the resources it needs, both through Congressional appropriations and by way of user fees, to guarantee the timely approval of new generic medicines,” he said. “Today's action is a real win for patients, providers, seniors and all consumers who rely of prescription medicines to improve their lives.”

A spokesman said the trade group did not have a statement Friday.

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