Senator Klobuchar Urges FDA Action To Deal With 'Unprecedented' Shortage Of Medications

Klobuchar Will Introduce Legislation to Address Drug Shortages

Recently, at Fairview Southdale Hospital in this Minneapolis suburb, U.S. Senator Amy Klobuchar urged the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.

Klobuchar said she will also introduce legislation in January to provide the FDA with new tools to deal with potential drug shortages.

Pharmacists and health care providers are reporting an "unprecedented" shortage of prescription drugs, especially for chemotherapy. The FDA currently lists 150 "medically necessary" drugs that are in short supply, which is double the number from five years ago.

Earlier this month, Klobuchar sent a letter to FDA Commissioner Margaret Hamburg, requesting "immediate action" to ensure adequate supplies of essential drugs.

Klobuchar noted that medications in short supply include everything from morphine for pain relief to propofol for sedation to leucovrin for cancer. There is also a serious shortage of pre-filled epinephrine syringes used in emergencies to treat heart attacks and allergic reactions

Experts cite a number of factors behind the shortages, including scarcity of some raw materials, manufacturing problems and unexpected demand. Business decisions within the pharmaceutical industry are also a factor, such as cutting back on production of low-cost generic drugs in favor of more profitable brand-name drugs.

"Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available," said Klobuchar. "That's not right. There needs to be better coordination between the pharmaceutical industry, the FDA and health care providers so patients don't lose access to the medications they depend on."

Klobuchar said she plans to introduce legislation next month to provide the FDA with better tools to address potential drug shortages in the future.

Specifically, Klobuchar said her legislation would give the FDA the authority to require early notification from pharmaceutical companies when they decide to limit or discontinue production of prescription drugs.

Klobuchar also said that when there is an impending shortage of a drug, the FDA should have the authority to establish an expedited process to approve substitute treatments or the importation of safe, clinically-equivalent drugs from outside the United States.

"We want to respect the private market, but we also need to protect the public's health," said Klobuchar. "This is a common-sense solution. It's not too much to ask to have an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible."

SOURCE: Senator Klobuchar