Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

REP. DINGELL's OVERSIGHT SUBCMTE. DEC. 19 GENERIC HEARING AND REPORT: FOLLOW-UP

Executive Summary

PHARMAKINETICS FORMER PRESIDENT/CEO STEVEN WOODMAN IS NOT SUBJECT of a Baltimore grand jury investigation, Woodman's lawyer Robert Plotkin (D.C. firm of Washington Perito & Debuc) maintained in a Jan. 10 letter to "The Pink Sheet." Woodman "was not, and has never been, a target of the Baltimore grand jury investigation or of any other grand jury investigation," Plotkin said. Furthermore, he continued, "Mr. Woodman has never received any written or oral communication, directly or indirectly, advising that he is a target of such an investigation, and no law enforcement official has ever reported to the contrary." A chart in "The Pink Sheet" (Dec. 24, p. 6-10) summarizing both hearing testimony from FDA Generic Compliance Chief Paul Vogel and a subcommittee report mistakenly implied that Woodman is under investigation. The subcommittee briefing paper, released at Rep. Dingell's Dec. 19 generic drug hearing, states that PharmaKinetics and its "former chief scientific officer have both been informed that they are targets of the Baltimore grand jury investigation." Woodman stepped down from the president and CEO positions in November ("The Pink Sheet" Nov. 12, T&G-10) and is no longer a full-time employee of PharmaKinetics; however, he has been a "business development" consultant for the firm during its transition period. PharmaKinetics disclosed in a press statement last August that the company and then-Chief Scientific Officer Mark Perkal, PhD, "are now targets" of the criminal investigation relating to the generic drug scandal ("The Pink Sheet" Aug. 13, T&G-1). Perkal resigned from PharmaKinetics in November and is no longer either an officer or a full-time employee, although he has worked with the firm on a consulting basis.

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS018639

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

Cancel