Senator to Draft Legislation to Mitigate Drug Shortages

At a press conference in Edina, Minnesota, on Dec. 30, 2010, US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an “unprecedented” shortage of prescription drugs, especially for chemotherapy. “Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no longer be available. That’s not right. There needs to be better coordination between the pharmaceutical industry, the FDA, and healthcare providers so patients don’t lose access to the medications they depend on,” said Klobuchar in a press release.

Klobuchar plans to introduce legislation this month that will give FDA new tools to mitigate future drug shortages. The legislation would enable FDA to require pharmaceutical companies to notify the agency in advance when they decide to limit or discontinue the production of prescription drugs. In the event of an impending shortage of a drug, the legislation would give FDA the authority to establish an expedited process to approve substitute treatments or allow 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 in the press release. “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.”

According to FDA, 150 “medically necessary” drugs currently are in short supply, twice as many as were in short supply five years ago. Such drugs include morphine for pain relief, propofol for sedation, and leucovorin for cancer. Prefilled epinephrine syringes, used in emergencies to treat heart attacks and allergic reactions, also are in short supply. In December 2010, Klobuchar sent a letter to FDA Commissioner Margaret Hamburg, requesting “immediate action” to ensure adequate supplies of essential drugs.

The scarcity of raw materials, limited manufacturing capability, production problems, and unexpected demand have contributed to drug shortages. Business decisions also have helped create shortages. Pharmaceutical companies have stopped producing certain drugs after deciding that production costs are higher than profits. Other companies have reduced their production of low-cost generic drugs to focus on profitable branded drugs.