BUSINESS 2/4/98
FDA Issues Blunt Message: Generic Drugs Are As Good As Brand Names
ÿÿ WASHINGTON -(Dow Jones)- 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.
ÿÿ 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, the Associated Press reported Tuesday.
ÿÿ "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."
ÿÿ Drug company DuPont Merck Pharmaceutical Co. is waging a fierce battle to
protect its $500 million-a-year Coumadin market from Barr Laboratories
Inc.'s
(BRL) new, cheaper generic version known as warfarin, the active chemical in
Coumadin. DuPont Merck is a joint venture between Merck & Co. (MRK)and
DuPont
Co. (DD).
ÿÿ DuPont Merck turned to state legislatures, arguing that the anticlotting
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.
ÿÿ 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, and at least nine others are considering them.
ÿÿ "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."
ÿÿ 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.
ÿÿ "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."
ÿÿ 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.
ÿÿ FDA's McGinnis responeded, "We found no documented cases of therapeutic
inequivalence with the generic product in what was submitted."
ÿÿ 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.
ÿÿ 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.
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ÿÿ All Rights Reserved. |
