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4/23/2004

FDA Improves Communication About Drug Shortages

Cheryl A. Thompson

In a behind-the-scenes effort by a handful of FDA personnel, the agency has accomplished what stakeholders in the drug shortage problem deemed the most feasible potential solution: establish better communication regarding drug product shortages.

"One of the major areas [undertaken since mid-2002] is ensure our means of communication with other involved groups are as good as we can make them," said Mark J. Goldberger, coordinator of FDA's drug-product shortage team in the Center for Drug Evaluation and Research (CDER).

Representatives of various stakeholders in the ongoing drug shortage problem initially met in July 2002 in Washington, D.C., at a meeting convened by the American Society of Health-System Pharmacists (ASHP) and the American Medical Association. Attendees suggested 33 "potential solutions for preventing or more effectively resolving shortages" and scored them on feasibility and relative impact (see November 15, 2002, AJHP Special Feature).

FDA has increased its contact with drug manufacturers' trade organizations, Goldberger said, and "continues very close communication" with ASHP. The Generic Pharmaceutical Association in particular has been "quite helpful to us," he said.

Some drug product shortages result from corporate decisions to stop a business line when profits drop below a certain level, Goldberger explained. As newer therapies gain in popularity and usage, the manufacturers of the older brand-name therapies—whose patents generally have expired—question whether efforts should be directed at products with greater profitability. But generic drug makers, he said, may view a small market share to be an attractive business venture.

"It's a delicate area for FDA to get too involved in," Goldberger said in describing the agency's role in recruiting generic drug makers to step in where brand-name drug companies have exited. But FDA has been telling the Generic Pharmaceutical Association about products in need of manufacturers.

Perhaps most obvious to the public are the enhancements that Goldberger said have been made to the Drug Shortages Web page, www.fda.gov/cder/drug/shortages.

Goldberger, who is acting deputy center director at CDER, has worked on drug shortage issues for about 12 years. "Initially, there were no full-time people assigned," he said.

But over the years, the project gained dedicated personnel. FDA now has three drug shortage project managers—Valerie E. Jensen, Rene Kimzey, and Jouhayna S. Saliba—who work full-time on problems and their solutions.

Support is also provided, Goldberger said, by the CDER groups in charge of generic drugs and compliance with manufacturing standards.

Jensen said her team hears about shortages internally from compliance and drug information personnel and externally from consumers, ASHP, and, to an increasing extent, the firms themselves. From there, she said, a drug shortage project manager "verifies that it's an actual shortage" then contacts the manufacturer and the appropriate FDA drug-review division to determine whether the product is a medical necessity, that is, used to treat or prevent a serious disease or medical condition and for which there is no other available source or alternative drug or therapy that the medical staff believes is an adequate substitute.

Kimzey said the team monitors the supply status of a growing number of "critical products" and all of the drug products with counterterrorism uses. This latter responsibility started with a handful of pharmaceuticals and now totals about 300—"a considerable workload," she said.

Susan S. Allen, associate director of scientific and medical affairs in the CDER Office of Compliance, said one member of the three-person drug-recalls team focuses on potential shortages resulting from the recall of a product from the market. If a recall may spark a shortage, Allen said, her staff member is "immediately on the phone" with other FDA personnel, such as the Drug Shortage Program staff, to address the issue. When assessing a potential drug shortage, FDA always conducts a risk-benefit analysis to determine how important the particular product is to patient care, she said.

Goldberger said manufacturing flaws involving an excipient may not require the recall of a medically necessary product if a shortage will ensue before the company can release its next batch of product. Likewise, a deviation of one or two percentage points from the allowable content range for the active pharmaceutical ingredient in a medically necessary product may not require a recall from the market if a shortage will result.

But FDA does not concede on manufacturing standards or practices when an injectable product is contaminated. "As a general rule," Goldberger said, "problems with injectable products are more serious" than with oral pharmaceuticals.

Goldberger, Allen, and the drug shortage project managers met March 9 with representatives of ASHP, the American Medical Association, and three other medical societies to discuss drug product shortages. He said FDA wants to convene a meeting with the Parenteral Drug Association and other groups and seeks to meet with the Pharmaceutical Research and Manufacturers of America to learn about manufacturers' views of the marketplace, such as why a firm decides to stop making a product.