U.S. Sen. Susan Collins is calling on congressional leaders to pass legislation that would help to prevent shortages of life-saving medications.
Many of the drugs in short supply are vital to hospitals and cancer centers, including anesthesia, chemotherapy and infection medications, Collins said in a press release.
“There are also continuing shortages of drugs used in emergency rooms and intensive-care units,” she said. “These shortages are causing serious problems around the country, including forcing some medical centers to ration drugs or postpone elective surgeries. It’s critical that Congress address this crisis as quickly as possible.”
Almost all of the Maine Hospital Association’s members expressed significant concern about drug shortages in a December 2011 poll conducted at the request of U.S. Sen. Olympia Snowe.
Nationally, hospitals report delaying medical treatments because drugs are in short supply. Nearly every hospital surveyed by the American Hospital Association last June reported dealing with a drug shortage in the previous six months and more than 80 percent postponed treatments as a result.
Medications for anesthesia, pain relief, infections and intravenous feeding are being used faster than drug makers can replace them. In February, hospitals were on the brink of running out of a critical drug for treating childhood leukemia called methotrexate.
The principal supplier in Ohio shut down after failing a federal inspection.
Collins urged leaders of the House and Senate committees with oversight of the U.S. Food and Drug Administration to support a provision requiring drug makers to give the FDA early notification of expected drug shortages.
Early notification is required now only in cases when the sole manufacturer of a critical drug plans to permanently discontinue it, which many argue addresses only a fraction of overall drug shortages.
Doctors may not learn of a drug shortage until a pharmacist calls up after the patient tries to fill a prescription.
The early notification provision was part of legislation introduced by U.S. Sens. Amy Klobuchar, D-Minn., and Bob Casey, D-Penn., and co-sponsored by Collins and Sen. Richard Blumenthal, D-Conn., that’s now being considered under the broader Food and Drug Administration Safety and Innovation Act. The act is a $6.4 billion, five-year reauthorization of so-called user fees that industries pay to the FDA to review their drugs and medical devices for safety and efficacy.
The four senators sent a letter last week to congressional leaders outlining their support for the notification provision.
Voluntary early notifications from drug makers helped the FDA to prevent nearly 200 shortages in 2011, up from 38 in 2010, according to the release.
The House and Senate passed bills late last month requiring early notification for anticipated drug shortages and are now working to merge them. Both bills outline enforcement steps the FDA can take to crack down on drug manufacturers that fail to comply with the early notification requirement.
The senators also backed provisions that would speed FDA inspections of manufacturing sites and reviews of new products that could alleviate drug shortages, require the FDA to keep detailed records of previous drug shortages and attempts to prevent them, establish a task force to improve communication within the FDA and with the public, and commission a report on price gouging.
The final FDA bill must be passed by the House and Senate before being signed into law. It’s expected to be sent to President Barack Obama before Congress leaves for its August recess.
The legislation does not address existing drug shortages. 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.
The majority of drugs in short supply are injected medications.
Often, scarce medications are manufactured by just a few companies, magnifying the impact when a plant runs into production problems, can’t obtain raw ingredients or fails an inspection. Unexpected high demand for a drug also can lead to shortages, as well as foreseeable disruptions, such as when drug makers decide to stop manufacturing medicines with poor profit margins.
A report released last week by the U.S. House Committee on Oversight and Government Reform places some of the blame for the shortages on overly aggressive regulation by the FDA. The report faulted FDA Commissioner Margaret Hamburg and the agency for failing “to ensure that ongoing enforcement is conducted in a manner that does not create unnecessary shortages or have unintended consequences.”
A list of current drug shortages is available at fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm.