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Better Ways Needed to Track Drug Safety: Report
Date:5/1/2012

TUESDAY, May 1 (HealthDay News) -- A management plan to gather, assess and respond to data about all medications' risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.

The U.S. Food and Drug Administration approves new drugs based on clinical trial evidence that their benefits outweigh their risks. However, the full range of a medication's effects may not become apparent until it is used by a larger, more diverse population over a long period of time, the FDA-sponsored report noted.

A number of drugs approved by the FDA were later found to have problems, including the pain reliever Vioxx, the diabetes drug Avandia and the cholesterol-lowering drug Crestor.

Report recommendations include:

  • The risk- and benefit-assessment and management plan for each drug should be a publicly available document that would gather data about the drug during its entire time on the market.
  • The document should describe known safety concerns at the time of the drug's approval or that become evident as it is used by consumers.
  • The document should also include all FDA regulatory actions taken on a drug, such as restrictions on its use or ordering a manufacturer to conduct further research after approval (postmarket research).

"It is not possible to know what the full range of a drug's benefits and risks will be until it is used by many different kinds of patients over time, so it is critical that FDA continues to monitor and learn about the effects of drugs after they are marketed," said report committee co-chair Ruth Faden, a professor of biomedical ethics and executive director of the Berman Institute of Bioethics, Johns Hopkins University, said in an Institute of Medicine news release.

The FDA already gathers much of this information but it is scattered across multiple records. Collecting this information in a single, publicly accessible format would show the FDA's commitment to this drug "life-cycle" approach and make the process more open, according to the report.

Among its other recommendations, the report also said the FDA should order postmarket studies only if: a regulatory decision cannot be made based on existing safety evidence; the research can sufficiently address concerns about a drug's benefit-risk balance to help lead to a regulatory decision; the results will be used to make a regulatory decision in a timely fashion; and the rights and interests of the research participants can be adequately protected.

In addition, the FDA should ensure that postmarket studies it orders are conducted in ways that are ethically and scientifically sound, the report said.

"Our report focuses on how the agency can be proactive so that situations in which a drug's benefit-risk profile becomes problematic can be detected earlier, and it details how FDA can get the additional information on a drug's safety in the most ethical and scientifically sound ways when questions arise," Faden noted in the news release.

Report committee co-chair Steven Goodman, associate dean for clinical and translational research at Stanford University School of Medicine, added: "We believe that the adoption of a life-cycle approach to drug approval and monitoring will help the agency strengthen its oversight, better tackle these complex decisions, and increase public confidence in the agency's ability to protect public health. This will become increasingly important as FDA looks for ways to safely expedite the drug-approval process."

More information

The U.S. Food and Drug Administration outlines how it manages drug safety issues.

-- Robert Preidt

SOURCE: Institute of Medicine, news release, April 30, 2012


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