Monday, August 18, 2008

Preemption: "The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,"

In a brief filed with the US Supreme Court, six current and former editors of the New England Journal of Medicine stated that consumers should be allowed to sue pharmaceutical firms for failing to warn about a drug's dangers, even if its prescribing information was approved by the FDA. The brief was filed in case being reviewed by the Supreme Court in which a jury awarded $6.8 million to a plaintiff who had her arm amputated after being injected with Wyeth's nausea drug Phenergan (promethazine).

The Vermont Supreme Court upheld the jury award in the case, which is now before the Supreme Court, and the lawsuit is expected to test whether federal drug laws should pre-empt state laws. In an interview, journal editor Jeffrey Drazen noted that "even if the FDA is doing the best it can, it simply can't see the future clearly enough to pre-empt manufacturers from litigation. The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public."

"The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the editors noted in the brief. The journal editors added that without the discoveries uncovered during liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

Along with the journal editors, 47 state attorneys general and two former FDA commissioners also support the plaintiff's position in the case. Opening arguments before the Supreme Court are scheduled to be heard on November 3.

by Anna Bratulic


Anonymous said...

Not to defend pharma here and I do recognize the shortcomings of the US FDA, but no group or body could ever guarantee 100% drug safety, even with the inside information of hidden ADRs. The public needs to be better informed that taking any drug entails a balance of risks and benefits. Automobile use results in ~50,000 deaths annually in the US but we don't litigate all the time (except for the Pinto, the Samurai, etc.); instead, we try to make the vehicles safer.

However, I certainly agree that only through litigation have the hidden risks of some drugs become publicly available. But I have to ask patients and docs if they would really be swayed by knowing of severe and potentially fatal side effects if the rate was 1 in 500,000.

Anonymous said...

In the past we have had, at worst, drug companies hide unfavourable drug trial information, or at the best, stick their heads in the sand when hearing of unfavourable data as they try to get their drugs approved. Now they want to hide behind the skirts of the FDA, yet still spend 30% marketing their drugs, including direct to consumers. They obviously want a big cake with lots of icing and be able to eat it too.