E-DRUG: U.S. FDA says generic drugs as good as brand names

[srahmad@essential.org]

E-DRUG: U.S. FDA says generic drugs as good as brand names
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February 4, 1998 WASHINGTON (AP) -- 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." 

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, California. His study, published in the 
journal Cardiovascular Review & Reports, was funded with a $500,000 
Barr grant. 

Copyright 1998   The Associated Press. All rights reserved.

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