The House Energy and Commerce Committee, Subcommittee on Health, holds a hearing Tuesday on H.R. 1346, the Medical Device Safety Act, the bill to eliminate federal preemption in civil suits involving FDA-approved medical devices. As described in this earlier post, this bill would invite a flood of suits in state courts, creating a jury-determined, patchwork regulatory regime that would discourage innovation and investment.
The witness list, now out, suggests regulatory policy is being determined based on who makes the best PR pitch.
- David Vladeck, J.D., Professor of Law, Georgetown University Law Center
- William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston
- Gregory Curfman, M.D., Editor, New England Journal of Medicine
- Bridget Robb, Gwynedd, Pennsylvania
- Richard Cooper, Partner, Williams & Connolly LLP
- Michael Kinsley, Seattle, Washington
David Vladeck? He was just appointed to Director of the Bureau of Consumer Protection in the Federal Trade Commission. (FTC news release.) How strange to have him wearing different policy/regulatory hats.
Dr. Curfman's appearance shows the New England Journal of Medicine continuing its transformation into an advocacy organization. The publication submitted an amicus brief in the prominent preemption case, Wyeth v. Levine, so you can't really call it a disinterested journal of science.
Bridget Robb is a Pennsylvania woman who fills the sympathetic Diana Levine role for medical devices. Robb has testified in the Senate before on her defibrillator malfunction; ABC's "Good Morning America" told her story last June under the headline, "Young Daughter: 'Mommy's Dying'"
Michael Kinsley, the liberal columnist, wrote a Washington Post commentary last year, "Drug Regulators in the Jury Box," criticizing the Supreme Court's ruling in Wyeth v. Levine. Litigation is a flawed method of regulating drugs, he argued.
Who will get the bulk of the media coverage, we wonder.