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

QUAYLE COMPETITIVENESS COUNCIL HAS "REFORMED THE DRUG APPROVAL PROCESS"

Executive Summary

QUAYLE COMPETITIVENESS COUNCIL HAS "REFORMED THE DRUG APPROVAL PROCESS," the Vice President declared Aug. 20 in his speech at the Republican convention in Houston. Accepting his nomination as the 1992 Republican candidate for Vice President, Quayle used the opportunity to say that his competitiveness council has "worked to save jobs and to save lives...[and] to speed up the availability of new medicines for people with life-threatening diseases like cystic fibrosis, cancer and AIDS." The Vice President also indicated that he will resist attempts by some members of Congress to eliminate the council or drastically change the way it operates. The council "will continue to lead the charge against unnecessary federal regulation," he said. Congressional Democrats, Quayle added, "have tried to kill the Council on Competitiveness, which stands up for the American people against the bureaucrats and the special interests." Sunshine Act legislation (HR 5702), which would require the Office of Management & Budget, the Council on Competitiveness or any White House regulation-reviewing body to make publicly available all records of meetings with lobbyists and government agencies regarding regulations, was passed out of the House Government Operations Committee on Aug. 6 ("The Pink Sheet" Aug. 10, T&G-2). The measure is pending on the House floor. In a recent letter signed by representatives of three major health associations, Quayle's council was accused of catering to special interest groups. The July 31 letter to President Bush from the American Heart Association, American Lung Association and the American Cancer Society calls on Bush to take the "ethically right and morally high ground in restoring the council to a role that it should be playing as an advisory committee." The letter cites the Competitiveness Council's "veto power" over federal regulations as a hindrance to the legal and beneficial operation of government, charging the council with serving as a "back door way to circumvent" the Administrative Procedures Act.

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

PS021377

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