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After Criticism, FDA Will Strengthen Drug Safety Checks

By Marc Kaufman and Brooke A. Masters
Washington Post Staff Writers
Saturday, November 6, 2004; Page A12

Responding to continuing criticism that it mishandled internal warnings that the painkiller Vioxx had deadly side effects and that antidepressants were being misprescribed for children, the Food and Drug Administration announced yesterday that it will strengthen its system for reviewing the safety of drugs already on the market.

Without saying that the agency had done anything wrong, acting Commissioner Lester M. Crawford outlined a series of steps the agency will take to become more aggressive about responding to reports of potentially harmful side effects.

The steps include establishing an internal program to ensure that the views of dissenting scientists are heard, a formal request to the National Academy of Sciences for a study of the FDA's safety monitoring procedures, and a renewed, nationwide search for a new director of the Office of Drug Safety. The position has been vacant for more than a year.

"We don't always understand the full magnitude of a drug's risks before it goes on the market," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, in a teleconference on the initiatives.

Galson rejected criticisms that the Vioxx and antidepressant episodes -- when FDA scientists accused superiors of suppressing warnings about the drugs -- reflected a major problem with the culture of the agency.

"It's a rarity," he said of the highly publicized disagreements. "It doesn't represent the culture, so we don't really think there is a need for an overwhelming cultural change."

Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee and recently a sharp critic of the FDA's actions, called the announcement "welcome, albeit late in coming."

"It's obvious that the leadership of the agency must take on what look like deep-rooted problems when it comes to putting public health and safety first and public relations second," Grassley said. "These initiatives need to take hold in a meaningful way and be more than an attempt to inoculate the agency in the face of alarming revelations."

Vioxx was taken off the market in September by Merck & Co. after a clinical trial was stopped because twice as many people taking the drug experienced cardiovascular disease as those taking a placebo. Several major medical journals have since published commentaries concluding that the drug should have been taken off the market earlier and criticizing the FDA for its role in keeping Vioxx on the market.

The agency also came under sharp criticism for its handling of internal reports about the possible increased risk of suicide among children prescribed antidepressants. After initially dismissing the link, the agency last month ordered all antidepressant drugs to carry a prominent "black box" warning to alert doctors that the medications can increase the risk of suicidal thoughts and behavior among children and adolescents.


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