Regulatory Focus™ > News Articles > UPDATED: Obama Signs FDA User Fee Bill Into Law

UPDATED: Obama Signs FDA User Fee Bill Into Law

Posted 10 July 2012 | By Alexander Gaffney, RAC 

US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012-12 days after the Senate approved the bill and 17 days after the House of Representatives passed the bill.

The bill now carries the force of law, though its provisions largely do not come into effect until 1 October 2012.

In a statement released by Press Secretary Jay Carney, the White House stated the President had "signed into law" FDASIA, also known as S. 3187, but provided no statement from the President regarding his support for the bill. The President seemed to be one of the few stakeholders not making a statement on the legislation's passage. Stakeholder groups released a barrage of statements after the legislation's passage was announced, including congressmen, health advocacy groups, patient groups and industrygroups.

In a statement, the Secretary of the US Department of Health and Human Services (DHHS), Kathleen Sebelius, called the law's passage a victory for patients and the stakeholder groups involved in formulating the legislation.

"[FDASIA] 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.

"While enactment of S. 3187 marks an important moment for innovators across industry, research and clinical care settings, its most important beneficiaries are the patients and families that will be helped by the next generation of affordable medical products this bill will help to foster," Sebelius added.

The legislation includes the reauthorization bills for the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), establishes user fees for generic drugs and biosimilars, grants FDA the authority to review applications more expeditiously, reauthorizes FDA's authority to compel companies to conduct pediatric clinical trials and takes measures to end drug shortages.

The measure was long-expected to be signed by the President, who released a statement of support for an earlier iteration of the bill in May. The law had also received overwhelming support in the House of Representatives and the Senate, where FDASIA passed almost unanimously in an increasingly rare show of bipartisanship.

Read more:

White House - Statement by the Press Secretary on H.R. 33, H.R. 2297, and S. 3187

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