Obama Signs FDA Bill

The new law reauthorizes fees charged to drug and device makers, creates new fees for the approval of generic drugs.

By | July 11, 2012

Wikimedia Commons, United States Congress


On Monday (July 9) President Barack Obama signed the US Food and Drug Administration Safety and Innovation Act (S. 3187) into law, reauthorizing user fees that the FDA charges pharmaceutical and device manufacturers as they gain approval for their products.

The law also establishes a new user fee program—raised as part of Obama's newly-legitimized health care legislation—that will require companies making generic versions of protein-based drugs, or biologics, called biosimilars, to pay upon approval of their generic products. The newly signed law also makes several changes to FDA policy meant to speed the approval process for drugs and devices, enacts changes aimed to increase the safety of the drug supply chain, and incentivizes the development of new antibiotics.

Kathleen Sebelius, Secretary of Health and Human Services, applauded Congress and the President for the quick passage and signing of the bill. Though reauthorization of the fees is required every 5 years, the legislative action represents an act of bipartisanship and celerity that is hard to come by on Capitol Hill these days. Both the House of Representatives and Senate passed the bill quickly and with overwhelming support from both sides of the aisle, meeting their stated goal of getting the legislation to the President's desk before the July 4 recess.

"S. 3187 is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development," Sebelius said in a statement. "This legislation will drive timely review of new innovator drugs and medical devices…and fund the new approval pathway for biosimilar biologics created by the Affordable Care Act."

Hat tip to Healthwatch.

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