02/03/1998 17:59 EST
FDA Says Generic Drugs Are As Good
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) -- The Food and Drug Administration, frustrated with a battle over a generic version of the popular
blood thinner Coumadin, has written 200 medical groups with a blunt message: Generic drugs are just as good as the brand
names.
In an unusual letter faxed late last week to doctor organizations and every state board of pharmacy, the FDA insisted
questions about generic drug equality are misplaced.
''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 giant DuPont Merck is waging a fierce battle to protect its $500 million-a-year Coumadin market from Barr
Laboratories' new, cheaper generic version known as warfarin, the active chemical in Coumadin.
DuPont Merck turned to state legislatures, arguing 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 forbid pharmacies from substituting any NTI 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. Those states 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 an NTI 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.''
FDA also examined more than 400 samples of 24 brand-name and generic drugs, and the generics met ''the established
standards of purity and quality,'' Nightingale wrote.
Barr, meanwhile, unveiled a clinical trial Tuesday that examined patients who switched from Coumadin to warfarin. The two
were equal, concluded Dr. Joel Neutel of the Veterans Affairs Medical Center in Long Beach, Calif. His study, published in
the journal Cardiovascular Review & Reports, was funded with a $500,000 Barr grant. |
