FDA Offers Soft Response to IOM Critique of Agency

ROCKVILLE, Md., Jan. 30 -- Four months after the Institute of Medicine scolded the FDA for its regulation of drug safety, the FDA countered with a response that sidestepped some of the key recommendations for reform.

For instance, even though the IOM pointedly noted that it can take many years for serious problems with new drugs to surface, and it recommended a re-evaluation of new drugs five years after approval, the FDA suggested a re-evaluation after only 18 months. The heart risks of Vioxx took more that five years to appear.

In its report The Future Drug Safety -- Promoting and Protecting the Health of the Public, the IOM said the FDA should require new drugs to carry a special label marking them as new for the first two years they were marketed. Moreover, the IOM said the FDA should block direct-to-consumer advertising of those drugs during those first two years.

In its response, the FDA said those recommendation was not directed at the agency.

The IOM recommendations said that drug companies should be required to register all clinical trials. This, too, said the agency, "was not directed at the FDA."

The IOM's request for drug-approval transparency, calling for the FDA to post all new drug application review packages on its Web site, was flatly rejected by the FDA.

On the other hand, the FDA said that it has hired management consultants to help its Center for Drug Evaluation and Research and the entire agency improve an organizational culture that the IOM said was "not optimally functional."

What the FDA is willing to do, according to its response, is to share data with large databases such as the prescribing database of the Department of Veterans Affairs and other private databases. By expanding its access to those databases the FDA said it can greatly expand its post-marketing data, which might help it spot potential problems sooner.

Additionally, the FDA has scheduled a public meeting for early next month to investigate the creation of a nationwide virtual, integrated, interoperable medical product safety network.

Without specificity, the FDA said it will also:

• Develop critical path initiatives to help identify cardiovascular risk of drugs
• Prevent drug-induced liver toxicity.
• Actively monitor influenza vaccine safety.
• Enhance long-term safety of gene therapy.
• Enhance blood safety.
• Identify ways to increase input from academia, industry, and the public to improve risk management.