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Obama signs bipartisan FDA bill

By Sam Baker - 07/09/12 03:33 PM ET

President Obama on Monday signed the bipartisan Food and Drug Administration bill that Congress approved last month.

Obama signed the Food and Drug Administration Safety and Innovation Act, which reauthorizes user fees that the FDA collects from the drug and medical-device industries. The fees must be reauthorized every five years.

It also creates a new fee for companies that sell generic drugs, and it makes several changes to FDA policy, mostly geared toward speeding the approval of potentially life-savings products and bolstering the agency’s oversight of safety issues.

Both the House and Senate moved the FDA legislation quickly and with broad bipartisan support.

Lawmakers met their goal of sending the bill to Obama’s desk before the July 4 recess — and before the Supreme Court’s healthcare decision, which could have dragged the FDA bill into a morass of symbolic amendments.

The FDA bill modifies part of Obama’s healthcare law by filling out the detauls a user fee program for the drug class known as biosimilars — comparable to generic versions of complex drugs known as biologics.

Health and Human Services Secretary Kathleen Sebelius praised the bipartisan effort as Obama signed the legislation Monday.

“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,” she said in a statement.


Source:
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/236773-obama-signs-bipartisan-fda-bill

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