June 19, 2018
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Heavier hand may be needed for drug shortage

Matt Rourke | AP
Matt Rourke | AP
In this June 14, 2011, file photo, bottles of prescription drugs as labeled Lipitor, TriCor, Plavix, Singulair, Lexapro and Avapro are displayed at Medco Health Solutions Inc., in Willingboro, N.J.

When cancer patients can’t get the medications they need and surgeries are delayed because anesthesia is not available, market forces have failed. Government intervention in business dealings is often misplaced, but in the instance of the growing prescription drug shortage, it is critical.

Drug makers can’t keep up with demand for some drugs, including those that are used to treat childhood leukemia and cancer. Last year was the worst on record, with shortages of 267 medications, according to the American Society of Health-System Pharmacists.

From 2006 to 2010, the number of drug shortages in the U.S. grew by more than 200 percent, according to a November report by the Government Accountability Office.

There are myriad reasons for the shortages. The maker of major leukemia and cancer drugs was recently shut down after failing a federal inspection. In other instances, manufacturing problems and a shortage of raw material has delayed production of needed medications. Sometimes, drug makers phase out a drug before ramping up production of its replacement.

As a result, hospitals are delaying surgeries, looking for replacement medication on the gray market and seeking federal permission to import drugs from other countries.

A survey of Maine hospitals, conducted at the behest of Sen. Olympia Snowe, found the shortages to be a top concern.

“We heard from almost every hospital in the state, and what became abundantly clear is that managing drug shortages wastes a phenomenal amount of time and money, and it detracts from patient care,” Sen. Snowe said in a statement.

Nearly every hospital surveyed by the American Hospital Association in June reported dealing with a drug shortage in the previous six months. More than 80 percent delayed treatment as a result.

A bill co-sponsored by Sen. Susan Collins would mandate prescription drug companies to notify the Food and Drug Administration well ahead of drug shortages. Notification is required now only in cases where just one manufacturer makes a particular drug.

The legislation, introduced earlier this month as an amendment to a federal transportation bill, also directs the FDA to provide timely notification to the public of shortages and steps the agency is taking to address them.

These are steps in the right direction.

“The shortages of these vital drugs are causing serious problems around the country, including forcing some medical centers to ration drugs, postpone elective surgeries, or even modify chemotherapy regimens mid-course,” Sen. Collins said in a statement this week.

Under a House bill, drug makers would be subject to a fine of up to $10,000 for each day they violate the notification requirements, with a cap of $1.8 million.

The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from drug makers, according to Sen. Collins’ office. That’s up from 38 in 2010.

If drug makers continue to be unable to better match needed medicine supplies to demand, regulators have no choice but to take a more heavy-handed approach.

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