Source Pravda.Ru

FDA to strengthen the safety system

The Food and Drug Administration (&to=http:// english.pravda.ru/usa/2001/10/18/18426.html ' target=_blank>FDA) is going to appoint the drug safety director and generally to strengthen the safety system.

As sick and elderly Americans competed in lotteries for scarce &to=http:// english.pravda.ru/main/2003/09/15/49980.html ' target=_blank>flu vaccine, members of Congress chided the FDA for relying on the word of Chiron Corp., a vaccine manufacturer, rather than investigating as aggressively as British regulators did.

Critics also have charged the FDA ignored risks associated with antidepressants and the &to=http:// english.pravda.ru/society/2002/01/19/25861.html ' target=_blank>drug Vioxx (painkiller), then intimidated its own reviewers when they pointed to safety problems in both cases, wrote Detroit Free Press.

"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.

Galson, however, rejected criticisms that the Vioxx and antidepressant episodes — where FDA scientists accused superiors of suppressing warnings about the drugs — reflected a major problem with the agency's culture.

"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. Chuck Grassley, R-Iowa, chairman of the Senate Committee on Finance and recently a sharp critic of the FDA's actions, called the announcement "welcome, albeit late in coming", reports Seattle Times.

According to the San Francisco Chronicle, Larry Sasich, a research analyst with the consumer watchdog organization Public Citizen's Health Research Group, said the FDA's actions miss the mark. "It's a whitewash," he said.

Sasich said the underlying frailty in FDA oversight is that its safety division, charged with catching signs that new drugs have unacceptable risks, lacks independent power to overturn decisions by the FDA staffers who grant drug approvals -- and whose reputations could be hurt by a reversal. The Office of Drug Safety should have independent power to recommend drug withdrawals and add warnings to drug labels, he said.

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