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

The two prosecutors in the continuing Justice Department investigations of the generic drug industry, U.S. Attorney Breckinridge Willcox and Assistant U.S. Attorney Gary Jordan are scheduled to update, Rep Dingell's (D-Mich.) House Oversight Subcommittee in a hearing on Dec. 19. The two Baltimore federal district prosecutors will appear on the first panel of the hearing. Willcox, whose term in office is expiring, is expected to deliver a parting shot against generic manufacturers. The prosecutor has not shied from vitriol in past comments on the industry. In a statement issued when American Therapeutics was sentenced in the Baltimore federal court, Willcox said the "depressing and sinister picture of the generic drug industry...will get even darker" as the investigation reveals that the firm's conduct "was altogether commonplace, and in many ways even benign, when compared to some of its competitors" ("The Pink Sheet" Oct. 22, p. 10). The second panel will comprise three FDA enforcement officials: the agency's Compliance Office Director Daniel Michels, Manufacturing & Product Quality Division Director Edmund Fry, and Compliance Office staffer Paul Vogel. Fry and Vogel have been directing the agency's special task force on generic drug industry investigations. Subcommittee Chairman Dingell cancelled another hearing that had been scheduled for Dec. 12. However, there is a chance that the hearing, which was to have addressed FDA/industry relations and their effect on drug approvals, will be rescheduled for Dec. 14 or 20.

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