White House supports PDUFA bill

White House supports PDUFA bill

May 18th, 2012 // 12:33 pm @

The White House issued a statement of support for an FDA reauthorization bill on Thursday.

“The administration strongly supports passage of S. 3187, the Food and Drug Administration Safety and Innovation Act, which will help speed safe and effective drugs, medical devices and bio-similar biological products to patients,” a statement from the Office of Management and Budget released Thursday read.

On Thursday, the Senate began consideration of the legislation, the Federal Food, Drug and Cosmetic Act, which creates a program where certain drug manufactures pay user-fees as part of the product-review process. The bill also increases the FDA’s user-fee program related to medical technology and certain prescription drugs.

“S. 3187 also enhances the tools available to the Food and Drug Administration to address drug shortages by requiring additional early notification of potential shortages, an action the administration called for in the 2011 Executive Order on drug shortages,” the statement continues.

Senate Majority Leader Harry Reid (D-Nev.) had previously expressed interest in moving the bill quickly. Reid hopes to come to an agreement on how many amendments Senate Republicans would like to consider for the bill so the legislation can come up for a vote quickly.

The Senate version of the bill is similar to a one in the House, H.R. 5651, which the House Energy and Commerce Committee approved by unanimous consent a week earlier.

“Promoting innovation, safety and access to medicines and devices is critical to the nation’s health, and the administration supports this bipartisan legislation that contributes to this goal,” the statement said.


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