FDA not getting information on potentially risky drugs, report says

Drugmakers are not providing enough information to the U.S. Food and Drug Administration about how patients and providers are using some of the riskiest drugs on the market, according to a report from the Office of Inspector General of the Department of Health and Human Services.

The FDA is under supervision of HHS. The report was released Wednesday and a link to the full report is here.

The report was done to assess how the FDA is handling what are called Risk Evaluation and Mitigation Strategies (REMS), which are supposed to check on whether potentially-dangerous drugs are actually doing what they are supposed to do after the FDA approves them.

The REMS can include checking on results, producing brochures to warn patients about side effects, limit which hospitals and pharmacies get especially dangerous drugs and special training for doctors.

If the drug is not doing what it is supposed to do - causing death or injury, for example - then the drug could be pulled.

Federal law also authorizes the FDA to require a REMS and enforce the production of that strategy.

But the report highlighted a key flaw in the law:

"The FDA does not have the authority to take enforcement actions against sponsors [drug companies] that do not include all information requested in FDA assessment plans," the report said.

So the drugmaker might have to file a report, but perhaps not a complete report. And there is no requirement on meeting a deadline. If a company gets the drug approved and is generating revenue, there is no financial incentive to hurry to complete a report that might have bad news and eventually lead to limits or a recall of the drug.

"If the FDA does not have comprehensive data to monitor the performance of REMS," the report said, "it cannot ensure that the public is provided maximum protection from a drug's known or potential risk."

While the report noted how the FDA is hamstrung by the parts of the law, it also criticized the agency for not completing its assessments of the drugmakers' plans in a more timely fashion.

The FDA agreed with most of the OIG's recommendations, but did not really respond to the suggestion that it push Congress to give it more authority. (Another sign of Congressional gridlock.)

"Pharmaceutical risk management is a relatively new and emerging scientific discipline. Accordingly regulatory experience with pharmaceutical risk management is also evolving" Peter Lurie, the FDA's acting associate commissioner for policy and planning, wrote in a response that was included in the report.