On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs. The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request
In early March, the Food and Drug Administration (FDA) issued draft guidance recommending that the “pharmaceutical industry avoid the use of [dibutyl phthalate (DBP)] and [di(2-ethylhexyl) phthalate (DEHP)] in [Center for Drug Evaluation and Research (CDER)]-regulated drug and biologic products,” including prescription and nonprescription products, because of “potential human health risks associated with exposure to…
Late last month, the U.S. Supreme Court ruled on a significant federal preemption case concerning an individual’s right to sue a vaccine manufacturer for injury that is alleged to have resulted from a defect in a vaccine’s design. The 6-2 decision (Justice Kagan recused herself) in Bruesewitz v. Wyeth held that a provision within the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design-defect tort claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. The NCVIA was originally enacted to establish a no-fault compensation program that serves as an alternative to the traditional tort system for resolving vaccine injury claims.
In 1995, the parents of Hannah Bruesewitz claimed that their daughter became disabled after receiving a vaccine manufactured by Lederle Laboratories (now owned by Wyeth). In response, they filed a vaccine-injury petition in the U.S. Court of Federal Claims, which the NCVIA designated to decide which vaccine injury claims should be compensated. After the Bruesewitz’s claim was denied, the parents sued Lederle in Pennsylvania state court alleging that Lederle was subject to strict liability and liability for negligent product design under Pennsylvania common law. The case was removed to the U.S. Third Circuit Court of Appeals, which sided with Wyeth on its summary judgment motion and held that the state law claim was preempted by the NCVIA.
The Supreme Court affirmed the Third Circuit decision based on a textual analysis of the NCVIA preemption provision, which reads: