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



Executive Summary

HHS INSPECTOR GENERAL NO LONGER INVESTIGATING FD&C ACT CRIMINAL VIOLATIONS, Rep. Dingell (D-Mich.) complained in a Nov. 15 letter to FDA Deputy Commissioner Benson. "The memorandum of understanding between yourself and" HHS Inspector General Richard Kusserow "regarding the possible professional assistance in criminal cases was permitted to expire on Sept. 30, 1990," Dingell wrote. HHS Secretary Sullivan testified at a July 18 hearing of Dingell's House Oversight Subcommittee that FDA and the Inspector General had "a new agreement" to "enable experienced [IG] criminal investigators to work with FDA in criminal investigations" with the acceptance of the Justice Department ("The Pink Sheet" July 23, p. 6). However, Dingell considers Sullivan's testimony to have been misleading in that the agreement to which it referred was temporary. "In retrospect, this [FDA/IG] agreement appears to have been done by the department merely to deflect the subcommittee criticism of Secretary Sullivan at our July 18, 1990 hearing into enforcement problems regarding violations of the federal FD&C Act," the letter states. Dingell's letter was prompted by an alleged delay by FDA in initiating a criminal investigation into the Pfizer subsidiary Shiley. Dingell claims that Shiley had made "possible false and misleading statements to the FDA" about its Bjork-Shiley heart valve. According to Dingell, FDA in March indicated it would initiate such an investigation following Oversight Subcommittee hearings regarding Shiley's handling of valve failures. "As you are well aware," Dingell wrote Benson, "the subcommittee has expressed doubts regarding the competence of the FDA to conduct criminal investigations on its own." In July 1989, Sullivan delegated to the Inspector General authority for criminal investigations into felony violations of the FD&C Act. He rescinded that authority last January, Sullivan has testified, because the Justice Department "would be unwilling to defend" in court the legality of such an overlap of FDA/IG investigational authority. The FDA/IG/Justice agreement struck last summer was to have reinstituted the 1989 delegation with modifications. Dingell reportedly is disturbed that even that agreement is defunct and criminal investigations into FD&C Act violations are being abandoned.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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