Regulating the safety of pharmaceuticals: The FDA, preemption, and the public's health

O'Neill Institute for National and Global Health Law, Georgetown University, Washington, DC 20001, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 06/2009; 301(19):2036-7. DOI: 10.1001/jama.2009.680
Source: PubMed
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  • JAMA The Journal of the American Medical Association 09/2009; 302(11):1169; author reply 1169-70. DOI:10.1001/jama.2009.1333 · 35.29 Impact Factor
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    ABSTRACT: On February 22, 2011, the US Supreme Court decided Bruesewitz v Wyeth LLC,1 holding that the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design defect claims against vaccine manufacturers in which the plaintiff seeks compensation for injury or death caused by a vaccine's adverse effects. The public health implications are profound because Congress designed the NCVIA to safeguard a social compact—ensuring access to vaccines by preventing the uncertainty of litigation, while also ensuring vaccine safety and effectiveness.
    JAMA The Journal of the American Medical Association 05/2011; 305(18):1900-1. DOI:10.1001/jama.2011.615 · 35.29 Impact Factor
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    ABSTRACT: Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion. The Rehnquist and Roberts Courts’ pro-business/pro-preemption jurisprudence is distinctly antiregulatory, invalidating major state public health rules, such as in occupational safety, tobacco control, and motor vehicle safety. Apart from the antiregulatory effects, there is maddening inconsistency. Consider three relatively recent Supreme Court cases. In Riegel v. Medtronic, Inc. (2008), the Court held that federal law bars injured consumers from challenging the safety or effectiveness of FDA-approved medical devices. A year later, in Wyeth v. Levine, the Court came to the opposite conclusion, ruling that injured consumers could sue pharmaceutical companies for failing to warn about the risks of taking brand-name drugs. On June 23, 2011 in PLIVA, Inc v. Mensing, the Court found that injured consumers could not bring failure-to-warn claims for injuries caused by FDA-approved generic pharmaceuticals. Thus, in less than four years, the Court barred state health and safety litigation for FDA-approved medical devices, allowed failure-to-warn claims for branded pharmaceuticals, and then barred those claims for generic pharmaceuticals.What is the rational basis for treating branded and generic medicines differently even though, by law, the products must be equivalent? Or treating branded drugs and medical devices differently even though they go through similar approval processes? As Justice Sotomayor (dissenting in PLIVA) put it, this “leads to so many absurd consequences that I cannot fathom that Congress would have intended to preempt state law,” while even Justice Thomas writing for the Court admitted this outcome “makes little sense.” This article examines the Supreme Court’s perversion of the preemption doctrine, the newest ruling on generic medicines, and the public health value of litigation.
    The Hastings Center Report 10/2011; 41(5):11-2. DOI:10.2307/41241299 · 1.68 Impact Factor
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