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FDA says generic drugs are just as good as brand names

The Food and Drug Administration has bad news for drug companies trying to fend off cheaper competition: Generic drugs are just as good as the brand names.

A letter faxed last week to doctor organizations and every state board of pharmacy signals the FDA's frustration with a fierce battle between the $500-million-a-year blood thinner Coumadin and its new generic competitor."There are no documented examples of a generic product manufactured to meet its approved specifications that could not be used interchangeably with the corresponding brand-name drug," wrote Dr. Stuart Nightingale, FDA associate commissioner. "Additional clinical tests or examinations by the health-care provider are not needed when a generic drug product is substituted for the brand-name product."

Drug-maker DuPont Merck has turned to state legislatures to fight Barr Laboratories' new, cheaper generic drug warfarin, the active chemical in Coumadin. DuPont Merck argues that the anti-clotting drug is part of a medical class informally called "narrow therapeutic index" drugs, meaning that slightly too high a dose can be dangerous and slightly too little is ineffective.

The idea was to persuade states to prohibit pharmacies from substituting any narrow-therapeutic drug with a cheaper generic unless doctor and patient approved. Three states have passed such laws - North Carolina, Texas and Virginia - and at least nine others are considering them. They are California, Massachusetts, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma and Tennessee.

"We are saying you have a chance of an adverse event when you switch products without knowing what's going on," said DuPont Merck spokeswoman Susan Pritchard. "All we're asking for is informed consent of a switch. We don't understand why people would be opposed to knowing which product you're going to be on."

The FDA says it wrote state medical groups because lawmakers are repeatedly asking the agency to clear up generic drug information. Pennsylvania officials even called the FDA late one evening as the Legislature was debating a narrow-therapeutic bill. The bill failed.

"When the agency approves a generic product, we stand behind the interchangeability of that product," said FDA pharmacologist Tom McGinnis. It "should produce the exact same results you'd expect from the brand-name product."

DuPont Merck argues that it recently reported to FDA more than 100 cases of patient adverse events that it believes were caused by switching from Coumadin.

Responded FDA's McGinnis: "We found no documented cases of therapeutic inequivalence with the generic product in what was submitted."