Pew Applauds Passage of Bipartisan User Fee Legislation by U.S. House of Representatives

Contact: Linda Paris, lparis@pewtrusts.org, 202.540.6354


Washington, DC - 05/30/2012 - The U.S. House of Representatives today passed bipartisan legislation to ensure that the U.S. Food and Drug Administration (FDA) has the funds it needs to approve products that improve health and protect consumers from unnecessary risks. The Pew Health Group worked with the House on three issues in particular: the security of the drug supply chain, antibiotic innovation and medical device safety.

The Food and Drug Administration Reform Act of 2012, H.R. 5651, contains provisions to improve the safety of the nation’s drug supply chain by allowing the FDA to more rigorously and consistently inspect foreign facilities, which supply 80 percent of the ingredients in our prescription drugs. The bill also includes measures to ensure the safety of medical devices and to spur the development of life-saving antibiotics. The House will need to work with the Senate, which passed its own version last week, to reconcile the two measures before final passage.

Allan Coukell, director of medical programs for the Pew Health Group, commended the bipartisan leadership of the House Energy and Commerce Committee, Chairman Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA), Health Subcommittee Chairman Joe Pitts (R-PA) and Ranking Member Frank Pallone (D-NJ).

“We commend House lawmakers for putting our nation’s health first,” said Coukell. “The American people will benefit in particular from measures that secure the global pharmaceutical supply chain, promote the safety of medical devices, and provide new antibiotics to the growing number of patients suffering from serious, life-threatening infections. We look forward to continuing to work with lawmakers as this critical legislation moves to the President’s desk.”

Since 1992, user fee agreements have given the FDA significant and sustained resources that allow the agency to review new products quickly. In fact, a recent, Pew-funded study published in the New England Journal of Medicine showed that FDA reviews new drugs faster than its counterparts in the European Union and Canada, and that American patients most often enjoy access to new drugs first. While the FDA inspects American manufacturing facilities every two years, it only has enough resources to inspect overseas locations on average every nine years. The landmark user fee agreement between the FDA and the generic drug industry (one of four included in the legislation) will enable the agency to close the gap between domestic and foreign inspections. The legislation also puts greater responsibility on drug makers to ensure the quality of their suppliers’ ingredients and strengthens customs and border protections to keep counterfeit and potentially unsafe drugs out of the country.

As the number of drug-resistant infections rises, not enough new antibiotics are reaching patients. Drug makers brought 29 different systemic antibiotics to market in the 1980s, 23 in the 1990s, and only nine in the 2000s. Thanks to the hard work of Congressmen Phil Gingrey (R-GA) and Gene Green (D-TX), the legislation includes the bipartisan Generating Antibiotic Incentives Now (GAIN) Act, which grants an economic incentive for the development of new antibiotics by extending exclusivity for certain qualified medicines.

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