FDA Accused of Intentionally Creating Drug Monopolies

By David Gutierrez

The outgoing chief executive officer of pharmaceutical giant Wyeth has accused the FDA of “establishing monopolies” by requiring new drugs to prove that they work better than products currently on the market.

“If you’re the first company to get approved in a certain area and competitors can’t get on the market, the FDA is now establishing monopolies. And that’s certainly not their mandate,” Bob Essner said.

Essner said that the FDA might have overstepped the bounds of its legal mandate, which is only to determine if drugs are safe and effective. “It could well be legally challenged,” Essner said. “Although that may not be a formal standard, it does appear to be a growing practice.”

The FDA denies that it is forcing new drugs to prove that they are more effective than old ones, but acknowledges that it does make such comparisons. “[The FDA] does not have what is called a ‘comparable effectiveness’ standard for drugs,” the agency said. “We do consider other products already available as we make benefit/risk decisions for new products.”

Dan Vasella, chief executive officer of Novartis, agreed with Essner’s comments. “The discussion on what this [drug] brings over and above what’s on the market is a question that’s being asked,” he said. “The FDA doesn’t seem to trust the physicians any more.”

Both Wyeth and Novartis have had drugs approved through FDA assessments that included a comparison of the drug’s effectiveness or place in the market relative to already-approved treatments. Three Wyeth drugs have been rejected or had their approval delayed in 2007: the osteoporosis drug Viviant, the antidepressant and menopause treatment Priztiq, and the schizophrenia medication bifeprunox.

Wyeth’s bifeprunox and Novartis’ Prexige, a painkiller, were the drugs subjected to market comparisons.