Wednesday
Mar042009
Bad day for the drug industry
Wednesday, March 4, 2009 at 10:57AM
The Supreme Court has ruled, 6–3, that states are free to impose their own labeling requirements on drug manufacturers despite the FDA's regulation of drugs. Justice Stevens wrote the majority opinion for himself and Justices Kennedy, Souter, Ginsburg, and Breyer. The case arose after Levine, a professional musician, lost her right arm to gangrene after injecting Wyeth's drug, Phenergan, a nausea drug, into her arm. A Vermont jury found that Wyeth should have provided a warning that direct injection into a vein (as opposed to administration through an IV drip) was dangerous, but Wyeth argued that the FDA had the sole authority to regulate drug warning labels. The Supreme Court rejected Wyeth's argument that it would need to get FDA approval for any label changes, since the FDA allows new information to be added, and that would have included "new analyses of previously submitted data." Further, the Court found that Congress never intended the FDA regulations to preempt state regulations; generally the Court looks for some kind of explicit statement from Congress when it intends to preempt state laws, and it found nothing close in this case, nor is it impossible for Wyeth to comply with both federal and state regulations, the Court found. The FDA itself said that its regulations preempt state law, but the Court requires that Congress authorize the preemption, not just the agency. Thus, states can impose their own drug labeling restrictions, so long as they do not conflict with the federal regulations.
Justice Breyer wrote separately to emphasize that this case does not present the question of what to do when an FDA regulation conflicts with state law. In this case, the Court found it was possible to comply with the FDA regulation and the state law, so there was no opportunity for the Court to consider such a conflict.
Justice Thomas agreed with the outcome. He emphasizes that under our system of government, "the States retain substantial sovereign authority." Further, federal laws only trump state laws when they are constitutional—when they are within Congress's enumerated powers and when they follow the legislative process. Therefore, anything short of an express Congressional mandate, passed and signed by the president, cannot preempt. Neither policies implied by Congressional enactments nor regulations promulgated by an agency rise to this standard, and Wyeth's arguments ascribe to the the drug labeling regulations more power than they have. He further notes that even if there were a direct conflict between state and federal regulations, Wyeth would still have a legal option: don't sell the drug at all.
Justice Alito wrote a dissent, joined by Chief Justice Roberts and Justice Scalia. Alito reviews the FDA's approval process and finds that the FDA's proclamation of a drug as "safe" should bind the states. He says that the agency has the power to find a balance between competing interests, and that finding should preempt state law. Citing a 1988 case that imposed Department of Transportation motor vehicle safety regulations on the states, Alito criticizes the majority's attempt to draw lines between that case and the current one. Alito also notes that stronger warning labels might not have helped Levine anyway: Levine's doctor ignored at least six other warnings on the drug label.
The case was Wyeth v. Levine, No. 06–1249.
Justice Breyer wrote separately to emphasize that this case does not present the question of what to do when an FDA regulation conflicts with state law. In this case, the Court found it was possible to comply with the FDA regulation and the state law, so there was no opportunity for the Court to consider such a conflict.
Justice Thomas agreed with the outcome. He emphasizes that under our system of government, "the States retain substantial sovereign authority." Further, federal laws only trump state laws when they are constitutional—when they are within Congress's enumerated powers and when they follow the legislative process. Therefore, anything short of an express Congressional mandate, passed and signed by the president, cannot preempt. Neither policies implied by Congressional enactments nor regulations promulgated by an agency rise to this standard, and Wyeth's arguments ascribe to the the drug labeling regulations more power than they have. He further notes that even if there were a direct conflict between state and federal regulations, Wyeth would still have a legal option: don't sell the drug at all.
Justice Alito wrote a dissent, joined by Chief Justice Roberts and Justice Scalia. Alito reviews the FDA's approval process and finds that the FDA's proclamation of a drug as "safe" should bind the states. He says that the agency has the power to find a balance between competing interests, and that finding should preempt state law. Citing a 1988 case that imposed Department of Transportation motor vehicle safety regulations on the states, Alito criticizes the majority's attempt to draw lines between that case and the current one. Alito also notes that stronger warning labels might not have helped Levine anyway: Levine's doctor ignored at least six other warnings on the drug label.
The case was Wyeth v. Levine, No. 06–1249.
Reader Comments (2)
Let's just talk about who IT'S GOOD FOR. How 'bout doctors that prescribe everything earning them a great big $Thousands of Dollars commission checks monthly. Also HMO's get kickbacks. Something's gotta be done to curtail the money paid for selfinterest. Patients have boot boxes full of pills and can tell you how each interacts with the other. And to top it off patients can even pronounce the prescriptions names. Gad zukes. Hold the doctors accountable too.
Drug companies like Pfizer and Wyeth can run but cannot hide. It is simply untrue that, as Wyeth attorney Rein asserts in a written statement:
"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label."
Drug companies 'negotiate' vigorously with the U.S. Food and Drug Administration (FDA) over the text of the warning label which accompanies each drug to the marketplace. Drug companies such as Pfizer and Wyeth hold the results of their clinical trials close, keeping from the public AND the FDA analysis of clinical data which link the use of their drugs to serious adverse events and deaths. Is it still true that potential tragedies for a 'few' American consumers become the 'cost of doing business' for Pfizer and others as they have practiced a strategy of lobbying to dilute FDA enforcement while also hiding behind it's 'expertise' as an insulation against litigation? Answer before today's supreme court ruling: Yes! Today's supreme court decision upholding a cash award for Ms. Levine may be an early warning signal to pharmaceutical companies such as Pfizer and Wyeth to take far more responsibility for what is contained in AND omitted from their warning labels. These drug companies have failed in their attempt to lead the public into believing that a chronically hog-tied Food and Drug Administration maintains ultimate legal and moral responsibility for the safety of the American public from harmful and deadly side-effects. How long did Pfizer think it could succeed with this strategy knowing how many deaths and other serious side-effects are suffered by its 'customers?' To pharmaceutical companies everywhere: If your product maims and kills people, you will be exposed and will pay either in negative publicity or cash or both. And when will either Bush or Cheney, leaders of an failed and embarrassed American administration, finally suffer a drug-company-induced serious adverse event? Sooner rather than later is my fervent hope.