Legislation Introduced to Help FDA Prevent and Control Drug Shortages

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By Stephen Spotswood

WASHINGTON — Unless FDA knows of a potential drug shortage in advance, the agency is not very effective in preventing or controlling that shortage, according to a recent government report. The agency also has failed to keep adequate records of past shortages, which could allow for a better understanding of why shortages occur.


Marcia Crosse, PhD

Faced with a mounting problem of drug shortages, the report released last month by the Government Accountability Office (GAO) provides a comprehensive list of the measures that FDA is unable to take, compared with the agency’s relatively small list of powers.

FDA cannot require that manufacturers report actual or potential shortages or require those manufacturers to take action to prevent or alleviate shortages. The agency cannot require companies to increase production of a drug in short supply or control the distribution or pricing of drugs. Nor can it prevent drugs from being sold on the gray market, where drugs are sometimes sold at one hundredfold their usual market price. [The gray market includes ways of buying prescription drugs that, while legal, are unofficial or unauthorized by the manufacturer. ]

According to Marcia Crosse, PhD, GAO’s director of healthcare, who presented the report’s findings at a Senate Health Committee hearing, FDA’s response is almost never proactive due to lack of information.

“Because FDA usually does not know about a shortage until it’s well under way, the agency’s approach to managing drug shortages is predominantly reactive,” Crosse explained.

That approach includes:

* Providing assistance to manufacturers to resolve quality problems;

* Encouraging other manufacturers to increase production;

* Allowing products to be marketed despite labeling or quality problems;

* Permitting the import of foreign versions of drugs; and

* Expediting review of drug applications.

Whether the last approach works to alleviate drug shortages is unknown. The agency currently has a backlog of 8,000 generic drug applications.

“FDA informed GAO that they have expedited the review of several hundred such applications in order to address shortages,” Crosse said. “However, FDA was unable to tell us whether any of the expedited reviews were completed in time to resolve a shortage.”

Foreknowledge Needed

The good news in the report is that, when FDA has information about a potential shortage, those same responses that minimally impact a shortage after it has begun can be used to prevent one.

“When FDA is informed of the possibility of a shortage in advance, the agency has increasingly been able to prevent drug shortages from occurring by taking the same kinds of action the agency used to respond to a shortage,” Crosse said. “FDA has prevented shortages of the majority of drugs where the agency learned of potential shortages in advance.”

In the past two years, FDA has, with early notification by manufacturers, successfully prevented 121 drug shortfalls.

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The majority of shortages occur with little or no warning, however, and that number is increasing. Five years ago, 55 drug shortages were reported. In 2010, there were 178. And, as of November, 231 had been reported in 2011.

In October, President Obama directed FDA to partner with the Department of Justice to focus attention on drug shortage and consumer protection issues. That directive also included a final rule involving sole source manufacturers. White House officials stressed at the time, however, that the order did not change the current law or give FDA more power than it previously had. For that, new legislation would be needed.

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