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

REP. DINGELL GENERIC DRUG HEARING SET FOR MAY 1: COMMISSIONER KESSLER and HHS Inspector General Richard Kusserow are scheduled to testify at the House Energy & Commerce/Oversight Subcommittee hearing. HHS General Counsel Michael Astrue was invited to testify but will not appear due to a scheduling conflict: he is scheduled to argue a court case for the department on the day of the hearing. An Oversight Subcommittee hearing that had been tentatively scheduled for April 25 has been canceled. That hearing was expected to examine the reasons for FDA's continued slow pace of ANDA approvals. The May 1 hearing is expected to focus on issues issue indicative of sloppy agency regulation of the industry. One such issue reportedly is the lack of legal authority for FDA's "alert list." The agency places companies on the list when inspections show them to be seriously non-compliant noncompliant with GMPs (good manufacturing practice regulations), and it will not approve pending marketing applications of listed firms until they rectify their compliance problems. Presumably because the procedure has no official legal foundation, FDA continues reviewing listed sponsor's sponsors' pending applications that it will not approve. Generic drug enforcement legislation drafted by subcommittee Chairman Dingell (D-Mich.) would codify the alert list procedure by granting FDA authority for "temporary denial of review or approval." Drug companies with clean enforcement records have argued that FDA review of their applications should not be delayed while the agency processes those of alert-listed firms. Dingell and Rep. Waxman (D-Calif.) met on April 16 to discuss their differences on the Michigan Democrat's legislation and resolved to continue negotiations. Waxman reportedly agreed not to oppose out of hand FDA enforcement legislation that is specific to the generic drug industry, although he would prefer a bill that applies to all agency-regulated related industries. On the other hand, Waxman, the Energy & Commerce/Health Subcommittee chairman, believes FDA should have greater discretion in imposing mandatory debarment penalties penalities than a draft of Dingell's bill would allow. Waxman also opposes the measure's retroactivity under which penalties penalities would apply to violations previously committed in the generic drug scandal, and he is said to be wary of the bill's application of corporate debarment based on the actions of one or two employees within a firm. Dingell is believed to have more than enough votes to move his debarment bill through his committee. However, if Dingell can persuade Waxman to sign on to the legislation, schedule a Health Subcommittee subcommittee markup, and refer the measure with a unanimous vote, the bill's prospects for enactment would be greatly enhanced.

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