The Case for Stringency

By Conlan, Michael F. | Drug Topics, February 2, 1995 | Go to article overview

The Case for Stringency


Conlan, Michael F., Drug Topics


For years, a liberal public interest group founded by Sidney Wolfe, M.D., and Ralph Nader has accused the Food & Drug Administration of being lax on drug safety. Now with a chorus of criticism from conservatives charging that the FDA's over-cautious approach is delaying approval of lifesaving medicines, Public Citizen's Health Research Group has rallied to the agency's defense.

The HRG said that the FDA's stricter safety rules had kept off the U.S. market dozens of dangerous drugs that had to be withdrawn in France, Germany, or the United Kingdom, thus avoiding thousands of deaths and serious injuries here. It also said that there was little evidence that important drugs are being delayed by the FDA.

The HRG based its arguments on a study of 56 drugs withdrawn or safety reasons in at least one of the four countries between 1970 and 1992 Only nine of the drugs had been approved by the FDA, and for three of them, Wolfe said, "manufacturers later pleaded guilty to criminal charges of withholding critical data concerning deaths or serious injuries from the FDA." The study made these comparisons:

* U.K.-U.S.--15 Rxs sold in the United Kingdom and later withdrawn for safety reasons were never marketed in the United States. Two Rxs sold in the United States and withdrawn were never sold in the United Kingdom.

* Germany-U.S.--24 Rxs withdrawn in Germany were never marketed in the United States. Three Rxs withdrawn in the U.S. were never sold in Germany.

* France-U.S.--28 Rxs withdrawn in France were never sold in the United States. Six U.S. Rxs withdrawn were never sold in France.

"It is clear from this study that the more stringent drug safety and efficacy laws and regulations in the United States have saved many lives," Wolfe said. He went on to say that "tens of thousands of deaths or serious injuries of Americans" would have occurred and more would be "a predictable consequence if our drug laws and regulatory policies were weakened as proposed by many . …

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