The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.
Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.
“We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system — what we can’t obtain we will not ask.”
Drug Makers Near an Old Goal: A Legal Shield
By GARDINER HARRIS and ALEX BERENSON
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.
But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.
This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
