As residents, we live in what many now call a medical mecca—there are health care facilities galore, and more under construction.
The House of Representatives Wednesday approved a major reauthorization of Food and Drug Administration programs related to approval of pharmaceuticals and medical devices.
Included in the Food and Drug Administration Safety and Innovation Act (S. 3187) was legislation authored by Congressman Tim Murphy (R-PA) to establish the first-ever program bringing life-saving generic medications to market faster and to close a major safety gap in the global drug supply chain.
“Real reform of the nation’s broken health care system begins with promoting quality and affordability," he stated. "Life-saving drugs are only useful if you can afford them, and with this critical legislation the FDA will finally have a system in place to bring more generics to the marketplace and inspect all overseas factories."
Murphy serves on the committee’s health panel and co-chairs the GOP Doctors Caucus.
Generic medications are estimated to save health care consumers $100 billion annually, according to a release. The typical senior citizen on Medicare saves $1,000 in out-of-pocket expenses annually from access to perfectly safe generic medications.
Murphy’s legislation, the Generic Drug and Biosimilar User Fee Act of 2012 (H.R. 3988), clears a backlog of 2,800 generic applications awaiting FDA review and factory inspection.
His bill will provide the resources needed for the agency to approve generic medications in a timely manner. The bill also addresses a major safety gap in the global drug supply chain illustrated by the 2007 contaminated heparin outbreak.
A Government Accountability Office study found the FDA had not inspected the Chinese plant responsible for producing counterfeit heparin, which killed nearly 200 people, and was only visiting foreign facilities on average once every nine years.
The Murphy bill moves the FDA toward inspecting foreign factories with the same rigor and biennial frequency that it does with domestic plants.
Murphy’s bill, which is funded by $1.5 billion in user fees from generic drug makers, is based on a historic user fee program agreement crafted by the FDA and generic drug stakeholders led by Mylan, which is headquartered at the business park Southpointe in Murphy’s district.
The Senate is expected to approve S.3187 as soon as this week. The legislation will then be presented to the president for his signature.