As Klobuchar Testifies in Support of Bipartisan Drug Shortages Legislation, FDA Announces Key Rule Change Advancing Bill

Press Release

As U.S. Senator Amy Klobuchar testified today in support of her legislation to help prevent shortages of critical drugs at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing, the Food and Drug Administration (FDA) announced a key rule change advancing Klobuchar's bipartisan bill, cosponsored by twenty senators including Senators Susan Collins (R-ME) and Bob Casey (D-PA). The FDA will now require sole-source manufacturers to provide early notification on any factor that may lead to possible shortages of medically-necessary drugs -- previously, the FDA only required sole-source manufacturers of "lifesaving" drugs to provide early notification of product discontinuances. Klobuchar's legislation would require early notification for all manufactures, sole-source or otherwise.

"Drug shortages have impacted countless individuals in Minnesota and across the country -- forcing some patients to delay their life-saving treatments or use unproven, less-effective alternatives. No family should have to face that choice," Klobuchar said. "Early notification of potential drug shortages will help the FDA better prepare for impending shortages, more effectively manage shortages when they occur, and minimize their impact on patient care. Both the FDA's announcement and today's hearing are important steps in moving this critical legislation forward."

In February, Klobuchar and Casey introduced the Preserving Access to Life-Saving Medications Act. The bill would require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage, as well as direct the FDA to provide up-to-date public notification of any actual shortage situation and the actions the agency would take to address them. The FDA has prevented nearly 200 drug shortages so far this year due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that the rise in preventions is due to increased pressure from Klobuchar and other members of Congress.

In October, President Obama issued an executive order advancing the key provision in the bill, which urged pharmaceutical companies to notify the FDA of impending prescription drug shortages. Today's FDA action took that order one step further by placing requirements on certain manufacturers of lifesaving, medically necessary drugs.

Klobuchar is a member of a bipartisan drug shortages working group in the Senate, which is aimed at bringing together patients, doctors, pharmacists, manufacturers, and the FDA to stop drug shortages.

A broadcast quality video of Klobuchar's testimony is available here.

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