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It wasn’t a banner year for the Food and Drug Administration as far as public image is concerned. Four times, the agency had to publicly pull a drug off the market due to severe reactions among the population taking it. The questions now are: What is going wrong with those drugs? And is it somehow the fault of the FDA? “They are losing the public trust,” says Abbey Meyers, president of the National Organization of Rare Disorders, a patients watchdog group. “It is undermining the faith that people have in new drug approvals. Right now, you could go to the doctor and he says, ‘There is a new allergy drug on the market, but let’s wait a year or so before I prescribe it to see if there are any problems.’ That didn’t used to happen.” The drug industry reaches a different conclusion. “We believe anytime there is a drug withdrawal, it shows the system is working,” says Jackie Cottrell, a spokeswoman for PhARMA, an association that represents pharmaceutical interests. The withdrawals began in March, when the agency decided to pull Rezulin, a very popular and well-known diabetes drug. Rezulin, which had been taken off the market in Great Britain in 1997, had been linked to 63 deaths in this country from liver failure. Propulsid, which was linked to 80 deaths, followed right on its heels. The drug’s manufacturer said it was pulling the heartburn medicine in the summer, but would provide the drug to patients with no other treatment options. In November, the FDA decided to start removing phenylpropanolamine from cold medicines and diet products, due to the increased risk of stroke in certain people taking the drug. Then Glaxo Wellcome Inc. decided at the end of the month to pull Lotronex, a drug for the treatment of irritable bowel syndrome, after meeting with the agency. The drug can cause severe intestinal side effects, including ischemic colitis and constipation. The deaths of several women are being linked to Lotronex. The removal of all these drugs, some just months after they were approved by the FDA, is raising questions about the adequacy of the agency’s approval process. The FDA did a self-assessment of its approval and post-market monitoring of Rezulin. The report concluded that the process “worked well” generally, but found problems with communication, division of responsibility for decisions, and standards for post-market review. But that is the extent of the FDA’s fault finding. The agency says that a review of drug withdrawals for the past several decades has not found inordinate increases. Nevertheless, the FDA is sending a warning signal to doctors. The agency is expressing concerns that drugs are being prescribed to some high-risk patients, despite warning labels. In a recent letter to the Journal of the American Medical Association, Dr. Janet Woodcock wrote that if doctors aren’t more careful about prescribing drugs to the right populations, “additional effective drugs are likely to be withdrawn, and some drugs may never become available in the first place.” The drug withdrawals are giving several public health groups ammunition to criticize the agency and the increased speed with which drugs move through the approval process. And they are placing the blame on the FDA Modernization Act of 1997, which cut the time frames for drug approvals in return for the FDA’s receipt of user fees from drug companies to cover the costs of those approvals. “Drugs shouldn’t be delayed. On the other hand, the first order of business is to ensure they are safe and effective,” says Arthur Levine, director of the Center for Medical Consumers, a nonprofit patients advocacy group. But drug companies say they are not concerned by the withdrawals. “I have seen no evidence that the FDA has lowered its standards in any way or has been less careful than it has been in the past,” says Donald Beers, a former FDA lawyer who now represents drug companies at D.C.’s Arnold & Porter. Ultimately, the issue comes down to risks vs. benefits — a complicated equation that the FDA wrestles with in each drug approval. Drugs cause side effects, sometimes quite severe ones. Even aspirin can cause death. The question is how the FDA balances those competing concerns — and, more important, what the public thinks of that balancing act. “None of these drugs were trivial drugs,” says Nancy Buc, former FDA chief counsel and a partner at D.C.’s Buc & Beardsley. “Even today, there are a lot of people who believe they should not have been removed from the market. Just because something happens later doesn’t make the decision to approve it a mistake. The FDA doesn’t deserve a black eye for this.”

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