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

REP. DINGELL’s FDA BILL "PRESENTS SERIOUS" THREAT

Executive Summary

REP. DINGELL's FDA BILL "PRESENTS SERIOUS" THREAT to the generic drug industry in that its focus is restricted to generic manufacturers, the National Association of Pharmaceutical Manufacturers maintains. In a May 30 memorandum to the association's membership, Chairman Edward Plymack and Legislative Committee Cochairman Michael Reicher asserted that the legislation introduced by Dingell (D-Mich.) "presents serious threats to the very existence of the entire generic drug industry." Introduced May 15, the Dingell legislation (HR 4810) causes NAPM consternation by "singling out generics as the only wrongdoers." In a May 22 position statement, the association contended that "irregularities are not limited to any specific segment of the pharmaceutical industry." The statement adds that "congressional strategy limiting legislation to the generic industry for fear of otherwise incurring innovator companies' opposition is contrary to the American concept of fair play." NAPM said it will oppose HR 4810 "unless and until inequities in the legislation are corrected." During the week of June 4, Rep. Waxman (D-Calif.), who opposes HR 4810, is expected to decide on a date to hold a hearing on the legislation before his Health Subcommittee. NAPM's memo notes that it also considers the HHS legislative proposal a threat to the industry. The department's version of the legislation would give "political appointees authority to essentially put companies out of business, even if they have not been convicted of a crime," the association said. The position statement acknowledges that HR 4810 "contains major improvements over previous drafts" and over the HHS proposal "in that it provides significant due process rights." The statement adds that "NAPM recognizes the need for legislation addressing irregularities in the drug approval process" and would support legislation "consistent with" the association's May 1 position paper. The May 1 document recommended legislation requiring manufacturers to remit to the government all profits from sales of drug products with "tainted" ANDAs or NDAs ("The Pink Sheet" May 7, T&G-15).

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

GB140150

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