When a Drug Is in Short Supply : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Sometimes FDA must take steps to avoid a drug shortage when the agency takes regulatory action, such as seizure or injunction, against a company. If shutting down a plant while the manufacturer corrects problems could lead to a shortage of a medically necessary drug, the agency may exempt that drug from the ban to keep it available.

To decide whether to make an exception for a certain drug, FDA must balance two risks: the risk from the noncompliance — for example, a manufacturing violation could result in a slightly less potent medication — and the risk of not having the product available at all.

For example, in spite of manufacturing problems, FDA allowed Ciba-Geigy's Desferal (as well as two other medically necessary drugs) into the United States from the firm's Swiss facility. FDA compliance officer Richard Friedman checked the quality of each lot of Desferal entering the country by analyzing extra data submitted by the company. "We worked closely with the firm to assure that products made it to pharmacies without delay and with no sacrifice in quality," Friedman says.

In other cases, a manufacturer may decide to stop making a drug simply because it is not a money-maker. In these cases, FDA or the National Organization for Rare Disorders may speak with other companies about making up the void. "To a big company, a market of $10 million or $20 million usually isn't enough," says NORD president Meyers, "but to a small company, that market might be attractive." (See accompanying article.)

Other times, because of poor planning or an unforeseeable event such as a plant explosion or fire, a company may not have the usual amount of time required to get agency approval of a manufacturing change, such as a move to a new plant. If an interruption in manufacturing may lead to a dangerous drug shortage, FDA can expedite its inspection of the new plant or its review of required applications.

In cases where a company is experiencing a temporary delay in production, FDA may talk to other companies who have the facilities to make the product short-term, or the agency may see if the manufacturer has some extra stock in its plant or warehouse that can help bridge the gap.

Managing the Demand

When a product is in dangerously short supply, the manufacturer or another party may set up an allocation program. That way, the drug is shipped directly to those who need it, rather than being shipped in large quantities to sit in a warehouse.

"Without a controlled allocation program," Goldberger says, "it's kind of like a gasoline shortage. Everyone rushes out and keeps their tanks full, and by keeping their tanks full, there's less gasoline to go around for those who really need it. If people just filled up when they needed to, you might not have a shortage."

To make sure anemic patients possessed only the amount of Desferal they really needed, Ciba-Geigy set up a distribution schedule to ensure that pharmacies only gave out a two-week supply at a time. "The company responded quickly by coming up with a distribution plan to make sure there was no gap in getting patients their drug," says Cioffi.

Shared Responsibility

Usually, dire shortages that require rationing can be avoided. Communication with the company and with specialized organizations such as NORD is the key, according to Goldberger.

The earlier FDA becomes aware of a possible shortage of a critical drug, the more effectively the agency can deal with it. "Part of the responsibility lies with the companies," Friedman says. "They should inform us as soon as possible if they anticipate a shortage of a medically necessary product."

FDA can sometimes help to avert a crisis or minimize the harm to patients if a shortage does occur. But, Goldberger says, "There are certain steps you have to go through to manufacture a product and get a product out on the market. FDA can speed up the process — find bridges — but we can't abolish it altogether or we couldn't be sure of the drug's quality."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.