The New York Times is running coverage of the FDA's enhanced warning, issued Wednesday, on the drug at the heart of Levine v. Wyeth, decided in the Supreme Court's last term, thus:
. . . .The fundamental issue was whether Wyeth or the F.D.A. was most responsible for warning consumers about the potential risks of Wyeth’s drugs. The Bush administration argued that the F.D.A. was the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts.
Had the [Bush] administration strengthened the warning on Phenergan while Ms. Levine’s case was being considered, the action might have undermined Wyeth’s case by confirming Ms. Levine’s argument that the previous warning was inadequate.
The F.D.A.’s new ruling, made Wednesday, resulted from a review of reports of "severe tissue injury, including gangrene, requiring amputation."
The change suggests that the Obama administration may view lawsuits as helpful to its work, a position that had been the policy of the drug agency before the Bush administration. . . .
I think this is accurate -- I think there is merit to allowing some enforcement to occur through the channel of private litigation.
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