User Fee Bill Passes the House

This article published with permission from The Burrill Report.

The U.S. House of Representatives in a unanimous voice vote approved a package of U.S. Food and Drug Administration user fees and other rules that would provide the agency with $6.4 billion in fees from drugmakers over the next five years, starting in 2013.

The vote moves the act — a compromise bill combining provisions from the House and Senate — to the Senate for a vote, its last stop before being sent to President Barack Obama to be signed into law.

The Food and Drug Administration Safety and Innovation Act of 2012 (S. 3187) will reauthorize several user programs, including the Prescription Drug User Fee Act, which give the FDA the ability to collect fees from industry in exchange for assurances of timely action on reviews of applications for new drugs, as well as generic drugs and biosimilars.

Key provisions of the act will support the FDA’s ability to address increasingly complex products and regulatory issues while helping the agency maintain the “gold standard” of safety and effectiveness of the medicines they regulate, says John Castellani, president and CEO of Pharmaceutical Research and Manufacturers of America.

The act also includes new rules to help improve communication so the FDA can detect and mitigate drug shortages and support the development of new and better antibiotics.

Despite gains for industry, including guarantees of better pre-review communication with the agency, some health advocates have criticized the dropping of provisions that would have supported a national network for tracking drugs throughout the supply chain. That requirement was struck during a reconciliation of the House and Senate bills.

If the act is passed — an event that appears to be likely given the broad support for it in Congress — it will renew the user fee programs through 2017.

Copyright 2012 Burrill & Company. For more life sciences news and information, visit www.burrillreport.com.