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FDA Sets Priority on Critical Drug Product Shortages

Kate Traynor

Although the Food and Drug Administration (FDA) investigates all reports of drug product shortages, the agency has limited regulatory authority to respond to shortages and therefore concentrates on resolving problems that pose more than just an inconvenience to clinicians and patients.

FDA focuses its attention on drugs the agency considers to be medically necessary—those needed to treat or prevent a serious medical condition and for which no acceptable alternative product exists. When evaluating shortages, says Lisa M. Hubbard, drug shortages product manager for FDA’s Center for Drug Evaluation and Research, the agency examines the underlying reason for the problem. FDA considers the national availability of alternative dosages and generic versions of the product and the estimates of product demand. If supplies surpass the expected demand, FDA steps aside.

Hubbard, a pharmacist, acknowledges that FDA’s policy on shortages can leave pharmacists searching for safe therapeutic alternatives for drugs not considered medically necessary or working with unfamiliar dosage forms or generic equivalents.

ASHP’s Joseph H. Deffenbaugh, M.P.H., who monitors pharmacists’ reports of drug product shortages, says patient safety is a big consideration. "You have to understand the differences between alternative drugs," he says. "There are subtle differences in potency, onset, and duration of action among drugs in the same therapeutic category."

Manufacturing problems, regulatory issues, raw material supply problems, and economic issues contribute to drug product shortages. According to Hubbard, shortages of raw materials are becoming more frequent as companies merge and the pool of bulk drug suppliers shrinks. And since problems contributing to shortages have grown over the years, Hubbard expects that drug product shortages will continue for some time.

Hubbard, who met with ASHP personnel in March, began working on drug shortages about two years ago and now deals with the issue full-time. FDA, she says, has a "team approach" to solving drug shortages. Dealing with these shortages consumes a growing amount of the agency’s resources.

FDA’s options for resolving shortages include working with alternative manufacturers, expediting the review of marketing applications from new suppliers, and using "discretion enforcement" for regulations that do not compromise public safety. When penicillin G sodium became unavailable in 1999 because FDA stopped production at a facility that had violated regulations, the agency arranged for an Austrian company to temporarily supply vials of the product through another U.S. company.

Although FDA can order the closing of a manufacturing facility, the regulatory agency cannot force a company to increase its production capacity. Likewise, when a company decides to stop making an unprofitable product, FDA’s recourse is limited. Although diplomacy sometimes gets results, Hubbard says, "we can't force a company to continue manufacturing a product."

For additional information, including suggested temporary replacements for certain drug products, visit ASHP’s Drug Product Shortage Management Web page. For a list of medically necessary products in short supply, visit FDA’s Web site.