House cheers, approves FDA reform bill

The House easily approved legislation on Wednesday that would reauthorize the Food and Drug Administration's user-fee program for brand-name drugs and medical devices, and expand that program to cover biosimilars and generic drugs.

After a brief debate in which both parties praised their rare and cordial bipartisan effort, members approved S. 3187, the FDA Safety and Innovation Act, in a voice vote.

"S. 3187 is a reflection of the hard work put in by both members and staff, and of everyone's willingness to put partisanship aside," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said on the House floor.

The user-fee program must be reauthorized periodically, which usually involves heavy input from affected industries. Those industries generally support the user-fee program, as those fees are used to help staff FDA with inspectors who render judgments on drug and device applications.

Both parties have said the new expanded program is one that would help ensure timely access to lifesaving drugs.

Both the House and Senate had approved similar versions of the bill — the House approved its version, H.R. 5651, in a 387-5 vote on May 31. House passage of the final compromise bill sends it to the Senate, which is expected to quickly approve it and send it to the White House for President Obama's signature.

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