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FDA Produces New Safety Plan To Speed Drug Risks Detection

By Gardiner Harris
THE NEW YORK TIMES

The Food and Drug Administration announced Tuesday changes to ensure that marketed drugs are as safe as advertised, including the first attempt to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way that it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.

The FDA plan is the latest attempt to fix the agency after a series of missteps. In September 2004, Merck withdrew its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attack. At about the same time, the FDA announced that anti-depressants cause some teens to think more about suicide.

In both cases, the FDA took years to acknowledge risks to millions of patients that had been apparent to some researchers.

“We don’t see this as the only answer,” FDA Commissioner Dr. Andrew C. von Eschenbach said at a news conference announcing the initiatives. “It’s merely a step as we continue a process of improvement that will be ongoing.”

Sen. Christopher Dodd, D-Conn., said in a written statement that far greater changes are needed at the FDA. Dodd promised to introduce on Wednesday two bills that would restructure the FDA and require drugmakers to disclose the results of all clinical trials involving humans. The bills have been co-authored by Sen. Chuck Grassley, R-Iowa, who has called the FDA far too “cozy” with drugmakers.

In many cases, the date that the FDA will undertake the efforts it announced Tuesday is uncertain. For instance, Dr. Steven Galson, director of the agency’s drug center, said at the press conference that the pilot program to systematically assess a drug’s safety 18 months after its introduction will probably take about a year to put into place — with the assessment due 18 months after that.

In a scathing assessment released in September, the Institute of Medicine concluded that the FDA was rife with internal squabbles.