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

Heparin scare may prompt law

This article was originally published in The Tan Sheet

Executive Summary

The House Committee on Energy and Commerce may propose "emergency legislation" requiring FDA to inspect and approve drug manufacturers before they ship products to the U.S., according to letters sent Feb. 21 to FDA and the Health and Human Services Department by Chairman John Dingell and Rep. Bart Stupak, Subcommittee on Oversight and Investigations chairman. The Michigan Democrats are investigating whether such legislation is necessary "to protect Americans" following FDA's failure to inspect a Chinese manufacturer that may be connected to the roughly 350 adverse events and four deaths related to Baxter Healthcare's injectable blood thinner Heparin (1"The Tan Sheet" Feb. 18, 2008, p. 15). The chairmen lambaste FDA, alleging the agency "abandoned ... its vital pre-approval inspection policy for the U.S. drug supply." In addition, they ask FDA, HHS and Baxter to turn over records related to the Heparin scare for further review...
Advertisement

Related Content

Heparin personal injury suit
FDA Template Good For Firms’ Recall Announcements – Consultant
Advertisement
UsernamePublicRestriction

Register

PS101395

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