After a day-long FDA hearing last week and a published report from NPR this morning, prescription drug shortages have become the latest public health issue with dire consequences.

According to the Food and Drug Administration, federal regulators are asking U.S. drug makers for advance warning of production shortages, saying medicine scarcities are continuing to increase at a rapid pace after reaching a record high in 2010.

The Obama Administration is also looking into stockpiling crucial drugs in short supply, according to a PBSNewsHour video (above).

Meanwhile, FDA officials are working closely with industry, health care providers, and patients to prevent and mitigate shortages of “medically necessary” medicines. Medically necessary drugs are those used to treat or prevent a serious disease or medical condition for which there is no alternative medicine available in adequate supply.

“The federal government should expand its collection of information on the underlying causes of drug shortages. Professionals need better information about shortages and available options.” – Len Lichtenfeld

FDA says shortages have been fueled by many factors, including a lack of raw materials used in the manufacturing process; increased demand for some drugs; and a company’s business decision to stop making some older, less profitable drugs.

Comments and presentations at last week’s hearing included suggestions for protecting the public, including tougher requirements for manufacturers to notify the FDA of drugs expected to be in short supply within the following six months, according to MedPage Today. Companies that are the sole source of a medically necessary drug are legally required to inform FDA six months in advance if they plan to discontinue making that product; however, there is no legal penalty if they choose not to do so.

The same report quoted Len Lichtenfeld, MD, deputy chief medical officer at the American Cancer Society, as saying any solution to the drug shortage problem needs to start with better information.

“The federal government should expand its collection of information on the underlying causes of drug shortages,” he said. “Professionals need better information about shortages and available options.”

DeWayne Pursley, MD, chief of neonatology at Beth Israel Deaconess Medical Center, who spoke on behalf of the American Academy of Pediatrics offered the following:

  • Develop a list of critical medications, including those for pediatric populations; those products should include drugs that come from a sole manufacturer.
  • Once the list is developed, FDA should determine how much of each drug would be necessary to have on hand to meet demand in case of a potential shortage and, based on that list, create a National Critical Medicines Stockpile.
  • Develop a system for two-way exchange of real-time shortage information.
  • Allow drugs in short supply to be imported in time- and quantity-limited amounts

Currently, if FDA gets advance warning that a shortage could occur, the agency works with other firms that make the drug and asks if they can ramp up production to fill any gap in the domestic supply of the product.

In certain situations, when manufacturers of an FDA-approved drug can’t immediately resolve a shortage of a medically necessary drug, FDA sometimes identifies foreign versions of the product with the same active ingredient manufactured by reputable firms. FDA then uses enforcement discretion for the limited importation of the foreign version until the shortage of the FDA-approved drug is resolved.

Last year, FDA was able to help prevent 38 drug shortages because companies notified the agency of issues that could lead to supply disruptions.