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.
DOD Official: Sailors Should Fight Somali Pirates Themselves
The most effective way to deal with piracy off of the Somali coast is for the sailors to defend themselves, according to a Defense Department representative testifying to the Senate Armed Services Committee today.
Michele Flournoy, Under Secretary of Defense for Policy, said that of the recent pirate attacks in Somalia the most effective means of fending off the pirates came from actions taken by the crews themselves.
“The single most effective short-term response to piracy will be working with merchant shipping lines to ensure that vessels in the region take appropriate security measures themselves,” Flournoy said. She continued that it is not possible for the U.S. military to prevent or intervene in every pirate attack, but if crews take appropriate measures, “the vast majority of pirate attacks can be thwarted without any need for military intervention.”
There were 122 attempted pirate attacks in 2008, of which only 42 resulted in crewmembers becoming captured. Of the unsuccessful attacks, 78 percent of them were stopped by the crews actions, with the others being stopped by military intervention, according to Flournoy.
Flournoy divided crew countermeasures into two categories: passive and active defense measures. Passive measures are those which don’t necessarily require direct confrontation with the pirates, and can include physical obstructions to boarding points, avoiding high-risk waters, creating fortified “safe rooms” in the ship, posting lookouts at all times, and maintaining contact with maritime security forces. Active defense measures can include using fire hoses and small arms to repel pirates and a military presence on the boat. Both of these defensive measures are important for crews to talk to defend themselves, Flournoy said.
She believes that the complexity of this situation necessitates a multifaceted approach, which is why the aforementioned measures should be combined with greater military patrols and economic development. Additionally, the Defense Department would like to see more states willing to prosecute the pirates. Presently, Kenya is one of the only nations to actually place Somali pirates on trial.
According to Flournoy, since August 2008 36 pirate vessels have been destroyed or confiscated, small arms have been seized, and 146 pirates have been turned over to law enforcement officers.