EDINA, Minn. — Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem. The senator said she also is pressing the Food and Drug Administration and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.
Klobuchar revealed her concerns on Dec. 30 while speaking at Fairview Southdale Hospital in this Minneapolis suburb. Noting that pharmacists and other health providers are reporting serious shortages of prescription drugs, especially for chemotherapy, she said she would introduce legislation this month to provide the FDA with new tools to deal with potential drug shortages.
“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available,” Klobuchar said. “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.”
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. In addition, the proposed law would arm the agency with the authority to establish an expedited process to approve substitute treatments or the importation of safe, clinically equivalent drugs from outside the United States when there is an impending shortage of a drug.
“We want to respect the private market, but we also need to protect the public’s health,” Klobuchar said. “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.”
In December, Klobuchar sent a letter to FDA commissioner Margaret Hamburg requesting “immediate action” to ensure adequate supplies of essential drugs. Those in short supply, she noted, include everything from morphine for pain relief to propofol for sedation to leucovrin for cancer.
“There is also a serious shortage of prefilled epinephrine syringes used in emergencies to treat heart attacks and allergic reactions,” Klobuchar’s office reported. “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.”