Sunday, August 31, 2008

The FDA, Preemption, and Drug Safety

Two items came to my attention this past week that are worth pondering in tandem. Item #1 I might as well shamelessly lift from the Prescription Project 27 August weekly reader e-mail notice:

Label liability?

And now to Washington, where this week the FDA finalized a rule that will make it tougher to update a drug label to reflect warnings and side effects.

According to the BNA Health Care Daily Report:
“The final rule published in the Aug. 22 Federal Register (73 Fed. Reg. 49603) allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the product.

‘Expressly requiring that a CBE supplement reflect newly acquired information and be based on sufficient evidence of a causal association will help to ensure that scientifically accurate information appears in the approved labeling for such products,’ the FDA said.

Critics are saying that the rule adds up to immunity for drug makers, who would no longer have to warn consumers about drug risks or new side effects without proof of causation and newly acquired information. The American Association for Justice, which holds the new rule protects drug manufacturers, told the BNA the FDA’s decision “leaves the drug and device companies too much discretion in determining when to include safety hazards on warning labels."

Item #2 is the amicus brief filed by the editors of the New England Journal of Medicine in the case of Wyeth v. Diana Levine, opposing federal preemption of state law ( The issue is the pharmaceutical industry's claim before the U.S. Supreme Court that no one should be able to sue them for product liability in a state court, because the FDA law at the federal level preempts state jurisdiction, making drug safety a federal and not a state responsibility. The factual claim put forth by the industry is that the FDA does a splendid job of monitoring new drugs for safety; that no further consumer protection via tort law is needed; that a company that markets drugs in accord with the FDA label for that drug should be immune from tort lawsuits if the drugs later cause harm; and that permitting the current system in which consumers may sue the industry for damages presents a hazard to the industry's financial well-being and a threat to the future public health.

To all of the the NEJM says hogwash, and proceeds to offer a detailed look at several recent drug safety debacles, where the firm clearly connived to suppress data showing safety problems for profitable drugs, particuarly Redux, Vioxx, and Trasylol. The NEJM brief concludes that there is ample evidence that the current FDA review system is flawed and needs as much help as it can get from the possibility of a tort lawsuit (which, as noted on this blog as well as in HOOKED, has the additional virtue of forcing the company to cough up internal documents that otherwise would remain secret, and that are often our only way to see what the companies are really up to). There is no evidence at all that the industry cannot handle the risk of tort suits or that the public health is in danger from overzealous warning about drugs that really are safe. (Indeed, one of the strongest arguments against allowing tort lawsuits for product liability to continue, is that under the current system, these threatened suits obviously do very little to get the industry to shape up.)

The way I put these two items together is to note that one might think that just when the Supreme Court of the U.S. is about to rule on preemption, the pro-industry folks would not want to provide even more blatant evidence of the weakness of the FDA warning and labeling system. Yet as Item #1 shows, that seems to be exactly what is happening right now. I can only make sense of the timing if I suppose that the pro-industry people inside the FDA leadership, or the pro-industry people in the White House, or both, are in a hurry to be sure that industry friendly measures are enacted during the Bush watch--with the prediction that either a McCain or an Obama White House would be rather less industry-friendly.


Anonymous said...

Kinda late here, but, indeed, we are about to go over a public health and civil rights cliff.

It is clear that there are several pieces of the strategy. (As Dylan might have said, you don't need to be paranoid to know which way the wind blows.) The labeling rule change, the CBE change (what warnings companies can/must do independent of prior FDA authorization), and preemption are all prongs in the same pitchfork.

Want to fight it?

The politicans aren't doing it. So it is up to the rest of us.

Anonymous said...

The FDA is of the opinion that, for new data to warrant the extraordinary step of bypassing normal agency pre-review, it must have at least as much causal connection as needed to justify a normal agency-approved warning. Thus, it has now changed this evidentiary standard specifically to require “sufficient evidence of causal association”:

"FDA proposed amending these provisions to affirm that a CBE supplement. . .may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or medical device."

That means that the rationale the court adopted for the time period relevant in Knipe is no longer available – and has been affirmatively rejected by the FDA.

Thanks for posting!