Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Division at FDA over preemption

This article was originally published in The Gray Sheet

Executive Summary

One week before the Supreme Court is scheduled to decide a major FDA drug law pre-emption case, Wyeth v. Levine, which is expected to result in some implications for devices, the House Government Oversight Committee throws more coals onto the fire of a drug and device law pre-emption dispute Oct. 29 by releasing a report, "1FDA Career Staff Objected To Agency Preemption Policies," stating that key FDA career staff strongly objected to drug labeling regulations generated by Bush administration appointees that would preempt state drug liability lawsuits. The report charges that "the agency's actions have undoubtedly helped shield drug manufacturers from liability," and publicizes an internal memorandum by Jane Axelrad, Associate Director for Policy at FDA's CDER, in which she warns her political appointee superiors that a 2008 drug labeling rule preventing drug makers from adding additional safety information to labels "is not, as it purports to be, consistent with the agency's role in protecting the public health" ("2The Gray Sheet" Oct. 13, 2008, p. 25)
Advertisement

Related Content

Wyeth Supreme Court Case Could Have Impact On Device Suits, Lawyers Say
Wyeth Supreme Court Case Could Have Impact On Device Suits, Lawyers Say
Advertisement
UsernamePublicRestriction

Register

MT026738

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel