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

UsernamePublicRestriction
UsernamePublicRestriction

ANDA FAVORITISM GRAND JURY INVESTIGATION

Executive Summary

ANDA FAVORITISM GRAND JURY INVESTIGATION could lead to indictments at the beginning of March, Bolar CEO Robert Schulman indicated at a generic industry conference sponsored by the investment firm Swergold Chefitz and held in New York Feb. 7. In response to a question from the audience on the status of the investigation, Schulman noted: "The gossip was, it was going to happen before Christmas; and, now, I hear February or March." Schulman's comments mirror Washington expectations about the indictment. Rep. Dingell's House Commerce/Oversight Subcommittee is reportedly waiting for the grand jury to finish its work before calling a hearing on the subject. The hearing could come very quickly after the grand jury's investigation is publicly disclosed. The grand jury investigation in Baltimore and the House subcommittee's work are concerned with allegations of payments to gain expedited reviews by FDA for generic drug applications. The probes reportedly have been more revealing than was initially anticipated. When the investigations were first made public, a handful of firms, one FDA reviewer, an industry consultant, and a generic stock analyst were said to be implicated. In addition to the firms that are known to be involved in the investigation -- American Therapeutics, Par, and its injectables subsidiary, Quad -- executives from at least three other generic manufacturers are understood to be associated with the investigation.

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

UsernamePublicRestriction

Register

MT101489

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