Magazine article Drug Topics

Firestorm Erupting over Generic Warfarin Release

Magazine article Drug Topics

Firestorm Erupting over Generic Warfarin Release

Article excerpt

The bloody bioequivalence battle over generic warfarin has spilled over into the media, or at least onto reporters' desks, as opposing companies fire off news releases.

"Once again, a branded pharmaceutical company is putting profits ahead of patients and seeking to manipulate the regulatory process to block competition," said Bruce Downey, president of Barr Laboratories. "On the eve of approval of an equivalent generic, DuPont Merck has asked the Food & Drug Administration to change the bioequivalency guidelines for this product, despite the fact that they had found these standards to be acceptable until Sept. 18. Barr intends to fight all attempts to deny hundreds of thousands of patients with heart disease the opportunity to purchase an equivalent generic at a fair price."

Barr's news release also said delayed approval of generic warfarin costs consumers $1.5 million daily.

On the same day (Oct. 1 ) that Barr sent its release, DuPont Merck responded, "It is unconscionable that Barr Laboratories would try to put pressure on the FDA to approve a generic version of an important therapy like Coumadin without the agency's careful consideration of important issues that could effect [sic] patient safety. Barr may be concerned about $1.5 million per day; DuPont Merck is concerned about the safety of 1.8 million patients whose lives depend on Coumadin everyday [sic] .

"DuPont Merck," the release continued, "has asked the FDA to tighten its standards to assure patient safety by adopting an individual bioequivalence test for this and all other 'Narrow Therapeutic Index' drugs. This would require that any generic warfarin product adhere to the same tight standards presently used in the manufacture of Coumadin. Coumadin and a number of other drugs such as phenytoin, theophylline, levothyroxine, digoxin, and carbamazepine have received this classification by the FDA because even slight decreases in medication can result in ineffective therapy, while slight increases may result in toxic effects....The company has been in contact with the FDA for nearly a year on this matter," the release said.

Even though bioequivalency challenges are increasingly common, the eye-poking arguments seldom spill out of FDA committee rooms into evenmore-public pathways such as the media. Jim Swarbrick, Ph.D., D.Sc., said that he's been on the FDA's Advisory Committee for Pharmaceutical Science (formerly the Generic Drugs Advisory Committee) for four years and that he has seen wide media coverage of such issues only a couple of times. …

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