Senate Bill Would Mitigate Drug Shortages

Last week, US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the Preserving Access to Life-Saving Medications Act, which is intended to help address and prevent shortages of prescription drug medications. The bill would enable FDA to require pharmaceutical companies to provide early notification when specified factors may cause a drug shortage. The bill names factors such as changes to raw-material supplies; adjustments to a manufacturer’s production capabilities; and business decisions such as mergers, withdrawals, or changes in output. In addition, the bill would require FDA to provide up-to-date public notification of shortages and of the actions that the agency would take to address them.

The American Society of Health System Pharmacists lists 151 “medically necessary” drugs that are in short supply, which is double the number of such drugs from five years ago. Many chemotherapy drugs are included on the list. Several factors, including a scarcity of raw materials, manufacturing problems, and unexpected demand, can result in shortages. Pharmaceutical companies’ business decisions, such as reducing the production of low-cost generic drugs in favor of more profitable brand-name drugs, also can lead to shortages.

“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available—that’s not right,” said Klobuchar in a press release. “As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA, and healthcare providers so patients don’t lose access to the medications they depend on.”

On Feb. 10, 2011, in response to reports that Merck’s Zostavax shingles vaccine is in short supply, Klobuchar wrote FDA Commissioner Margaret Hamburg about the problem. In her letter, she urged FDA and the Centers for Disease Control (CDC) “to work with manufacturers, providers, and other stakeholders to find an immediate solution to the shortage of Zostavax.” CDC recently recommended that Americans over the age of 60 be vaccinated to prevent shingles, but many orders will not be filled until April, according to the manufacturer.

In January 2011, Klobuchar called for the pharmaceutical industry to address the shortage of prescription medications at an event at Fairview Southdale Hospital in Edina, Minnesota. Klobuchar spoke to FDA officials about this issue several times and recently asked FDA Commissioner Margaret Hamburg to take immediate action to ensure adequate supplies of essential chemotherapy drugs.

See related PharmTech articles:
Lethal Injections and Foreign Inspections (blog post)

The Executioner’s Drug (blog post)

Senator to Draft Legislation to Mitigate Drug Shortages (ePT)