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House Passes Legislation to Help Prevent Drug Shortages

FDA Reform Act of 2012 will ensure patient access to life-saving drugs

Washington – Congressman Bill Shuster (PA-09) is pleased to announce that the House of Representatives passed H.R. 5651, the Food and Drug Administration (FDA) Reform Act of 2012, with overwhelming support. This important bipartisan legislation will require manufacturers to provide early notification to the FDA of pending prescription drug shortages. These notifications will keep patients like Amy Hanna of Altoona from dealing with the undue stress of losing necessary drugs that allow them to live their lives. Hanna was recently featured in a story by WTAJ highlighting her struggle to access the drug that keeps a tumor at the base of her pituitary gland under control.

“This bill helps patients, hospitals, doctors and nurses deal with the current drug shortages crisis,” Shuster said. “Drug shortages have been an unfortunate and ongoing problem in this country, with many people unable to get access to life saving medicine they rely on. I am proud that Congress was able to come together in a bipartisan fashion to address this issue and provide key reforms to help prevent and alleviate drug shortages.”

This legislation will also enable the FDA to expedite applications for manufacturing changes for drugs in shortage, and will improve the FDA’s record keeping related to drugs in shortage.

Another important piece of the FDA Reform Act will help incentivize the development of new treatments for children with rare pediatric diseases. These treatments are often less profitable than treatments for more common medical conditions, which keeps manufacturers from looking for cures. This plan expands the priority review voucher program to include treatments for rare pediatric diseases, such as childhood cancers and cystic fibrosis.