Those who would question generic drugs' equivalence to the brand-name drugs they mimic are calling into question a stringent FDA review process, said Jaeger. "They do a disservice to our healthcare system," she added. "Consumers deserve better."
But many physicians and pharmacologists interviewed said that with some drugs, the FDA -- an agency that has come in for harsh criticism on matters of drug safety in recent years -- may be overlooking differences that could be important to patients' health.
FDA officials "have adopted a position that is in some respects quite brave," said Peter Meredith, a University of Glasgow pharmacologist who has written extensively about generic drugs and their regulation. "The FDA quite rigidly states that when they say a drug is substitutable, they mean that with no caveats, no qualifications. My concern would be that if you don't look for one, you don't see it."
With about 9,000 generic drugs on the U.S. market, concerns raised about a handful do not suggest a broad failure in the nation's formulary of low-cost medications. But many physicians and pharmacologists caution that with new generics entering the market at a rate of almost 500 per year, and millions of consumers switching to them, their safety and effectiveness will be increasingly critical.
"The reasonable people I know aren't pounding their fists saying all generics are bad," Kowey said. "They're saying to the FDA, 'C'mon guys, there may be some situations in which [these differences] may turn out to be important.' "
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Doctors, users speak out
Dr. Gerald Naccarelli, chief of the Pennsylvania State medical center's division of cardiology, believes a switch to a generic drug to control heart arrhythmia contributed to the death of one patient in Houston early in his career. Recently, he said, another of his patients suffered a life-threatening ventricular arrhythmia after the man was switched from a long-standing regimen of a brand-name medication to a new generic. The patient was hospitalized but lived. When the FDA approved a generic version of an anti-arrhythmia drug that Naccarelli did not believe had been studied properly at higher doses, he wrote a letter to the FDA.
"I'm confused why there's one set of standards for patented trade-name drugs for FDA approval and a separate standard for generic substitutions," he said. "Some generic drugs . . . should be held to higher standards than the FDA now enforces."
