Pink Sheet is part 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


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...

You may also be interested in...

Heparin personal injury suit

A personal injury lawsuit was filed against Camden, N.J.-based Baxter Healthcare in federal court in New Jersey, according to New York-based law firm Lieff Cabraser Heimann & Bernstein. The plaintiff in the law suit claims to have suffered a near fatal adverse reaction from Baxter's contaminated heparin prescription blood thinner. The complaint seeks damages for physical pain and medical expenses, along with punitive damages to prevent Baxter from "similar wrongdoing in the future," according to the firm's April 3 release. Baxter came under fire after its failure to inspect a Chinese manufacturer that was the source of an ingredient used in heparin products that may be connected with hundreds of adverse events and four deaths (1"The Tan Sheet" Feb. 25, 2008, In Brief)...

FDA Template Good For Firms’ Recall Announcements – Consultant

FDA should request that firms use a proposed template for the agency's recall announcements to communicate their recalls to the public, a consultant said at the first meeting of the Risk Communications Advisory Committee

QUOTED. 18 June 2021. Harith Rajagopalan.

Fractyl Health closed a $100m financing round to support ongoing development of duodenal mucosal resurfacing (DMR) technology that addresses root causes of type 2 diabetes. CEO Harith Rajagopalan spoke of his hopes for the technology.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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