Washington, DC — The House of Representatives today 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 Reform Act (H.R. 5651) was legislation authored by Congressman Tim Murphy (R-PA) to establish the first-ever program bringing life-saving generic medications to market faster and closing a major safety gap in the global drug supply chain.

“Building an affordable healthcare system requires access to safe, cost-effective medications. This bill will save lives and billions of dollars for consumers,” said Rep. Murphy, who serves on the Committee’s Health panel and co-chairs the GOP Doctors Caucus.

Generic medications are estimated to save healthcare consumers $100 billion annually. The typical senior citizen on Medicare saves $1,000 in out-of-pocket expenses annually through access to perfectly safe generic medications.

Murphy’s legislation, the Generic Drug and Biosimilar User Fee Act of 2012 (H.R. 3988), 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 also expedites approvals of generic pharmaceuticals and eliminates a 2,800 generic application backlog within the agency. Currently, the FDA is supposed to make a decision on a generic application within 16 months. But the agency is taking twice that amount of time because it lacks resources for conducting reviews and inspecting factories. The foreign inspection and application review program within Murphy’s bill is funded by $1.5 billion in user fees from generic drug makers.

Murphy’s legislation 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 has passed a similar FDA reauthorization bill. Differences between the Senate and House measures are expected to be resolved sometime this summer before being presented to the President for his signature.

Mr. Murphy’s floor statement is below.

Mister Speaker –

This year, a typical senior will spend 15 percent of their household income on healthcare, including 620 plus dollars on prescriptions.

But that sum would be much higher if there were no FDA-approved generic pharmaceuticals.

Without generics, that same senior might pay $1,000 for medicine. And Medicare would spend some 67 billion more dollars.

We must always assure that any medication — brand name or generic — is of the highest quality. But currently the Food and Drug Administration cannot assure that medicines coming in from overseas factories such as those from China are pure.

The bill includes my legislation, the Generic Drug and Biosimilar User Fee Act, to authorize for the first time an FDA program that will expedite approval of generics and clear a backlog of over 2,800 generic applications.

Currently, the FDA is supposed to make a decision on the application within 16 months. But the agency is taking twice that time because it lacks resources for conducting reviews and inspecting factories.

U.S. factories are inspected perhaps once every two years and more often if the FDA decides; foreign factories perhaps seven to nine years and that means millions of dosages of drugs coming in from overseas without any inspection.

And recall what happened when Heparin ended up killing perhaps one to two hundred people.

Ninety percent of pharmaceutical ingredients are made in foreign factories but we cannot remain dependent from other countries that are below U.S. standards. People of all ages deserve peace and mind and we all want to have the highest trust for all medicines either brand name or generic. This bill will restore and support that trust for Americans and consumers.

And I yield back.

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