FDA proposes new rules to curb U.S. drug shortages


WASHINGTONThe Food and Drug Administration announced new proposals aimed at heading off more shortages of crucial medications that have hampered care at hospitals and health clinics nationwide.

Under the proposed rule, companies that make widely-used prescription medicines would have to notify the FDA of any changes in drug production that could disrupt the U.S. supply.

"Drug shortages pose a significant public health treat," FDA commissioner Dr. Margaret Hamburg told reporters Thursday. "As a physician and a mother, there are few situations that frustrate me more."

FDA leaders say the advance warning will help the agency work with companies to resolve supply problems or find alternate sources of drugs that are being phased out. Agency officials told reporters that as recently as two years ago, they wouldn't find out about drug shortages until the products didn't make their way to store shelves and patients complained.

The new proposals will build on the FDA's ongoing efforts to curb these shortages. The U.S. has seen a spike in drug shortages over the past six years, particularly inexpensive generic injected drugs, including powerful antibiotics, painkillers and anesthetics used in surgery. They are the workhorses of hospitals but often produce little profit for companies.

In Oct. 2011, President Barack Obama announced plans to sign an executive order to instruct the FDA to take action on drug shortages.

Following that order, a group effort from the FDA, drugmakers and doctors has led to "important progress" being made against shortages, the agency told reporters.

In 2011, there were 251 drug shortages reported but in 2012, the number dropped to 117 shortages. The FDA said it prevented 195 drug shortages in 2011, but prevented more than 280 last year.

"This is really important progress but more needs to be done," said Hamburg.

There are two new proposals that have been submitted. For the first, the FDA will release a long-term strategy to the public and Congress of how to improve response and mitigate drug shortages. The agency noted 70 percent of drug shortages are caused by breakdowns in manufacturing and processing.

The other proposal would require manufacturers to notify the FDA of any interruption of manufacturing that may affect drug supply, or any permanent discontinuance relating to manufacturing. Instead of being notified by the drug's sole manufacturer, the FDA's new proposal requires all manufacturers to notify the agency of problems, including companies that make biologic products like those involved in blood transfusion.

"The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Penalties against companies that don't comply would not be very severe. FDA officials said Thursday the agency will post on its website "non-compliance" letters to companies that fail to provide enough advance notice.

"We think that putting those up would emphasize the importance the FDA is placing on timely notification," FDA deputy director for regulatory programs, Dr. Douglas Throckmorton, told reporters.

The FDA will take comments on its proposed rule for 60 days, before revising and finalizing it.

The forces behind recent drug shortages include consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs. Many shortages are also caused by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories. Recalls of huge batches of some drugs due to contamination by bacteria, fungi and tiny glass or metal particles have exacerbated shortages.

The recent spate of recalls has forced the FDA to increasingly allow imports from foreign factories that normally don't ship to the U.S.

While once considered an extraordinary step, the agency has been forced to allow the importation of 17 drugs to combat U.S. shortages. Most recently, the agency authorized temporary shipments from Norway of intravenous formula used to feed newborn infants, cancer patients and other frail patients who cannot eat or drink by mouth.