US advises firms on better drug safety monitoring

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U.S. health officials gave drug companies suggestions on Thursday on ways to improve safety evaluations of medicines during early-stage development and after they are on the market.

The new guidelines are part of broader agency efforts to take a more “proactive” approach to identifying drug hazards, a Food and Drug Administration statement said.

The FDA has been on the defensive after a series of safety problems involving widely used drugs on the market, including Merck & Co. Inc.’s withdrawn pain pill Vioxx, which was linked to heart attacks and strokes.

The guidelines recommend specific tests or analyses companies can do to shed light on possible safety issues. Officials also urged drug companies to discuss safety monitoring with regulators sooner in the development process.

“Our hope is that earlier discussions will lead to better studies and more thorough assessment of safety issues prior to approval,” Dr. Paul Seligman, director of pharmacoepidemiology and statistical science in the FDA’s Center for Drug Evaluation and Research, told reporters.

The agency also encouraged more focus on plans to minimize known risks of certain medicines. For example, companies could develop special training programs for doctors or consent forms for patients that highlight dangers and proper usage.

Seligman said the FDA did not intend for the added safety scrutiny to delay the approval of new medicines.

“What we are really trying to do… is make sure people think about and anticipate as many of these safety concerns as early in development as possible,” he said. 

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