Pink Sheet 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

Off-label promotion on Waxman’s oversight agenda

Executive Summary

Both drug companies and federal officials are slated to feel the heat as the House Energy and Commerce Committee examines off-label marketing of drugs during the 111 Congress. The item is on the committee's oversight agenda, which was proposed by Chairman Henry Waxman, D-Calif., and approved by the panel Feb. 10. The agenda includes a review of FDA, CMS and Justice Department efforts to investigate and prosecute manufacturers that violate federal standards, as well as a look at drug makers' activities. FDA's January issuance of final guidance on off-label reprints was panned by Waxman as "a long-coveted parting gift" to industry from the Bush Administration (1"The Pink Sheet," Feb. 2, 2009, p. 41). In his previous job as chairman of the Oversight and Government Reform Committee, Waxman had sought an explanation from FDA as to why the reprint policy was considered a priority (2"The Pink Sheet," Sept. 22, 2008, p. 28)
Advertisement

Related Content

Forest Celexa, Lexapro Off-Label Promotion, Kickbacks Alleged In DoJ Suit
Off-Label Reprint Guidance: “Definitely Improved,” But Will Waxman Fight On?
Off-Label Reprint Guidance: “Definitely Improved,” But Will Waxman Fight On?
Waxman Asks FDA To Explain How Its Regulatory Priorities Aid Public Health

Topics

Advertisement
UsernamePublicRestriction

Register

PS050729

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