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

CLINTON/GORE TICKET PAIRS CANDIDATES WITH EXPRESSED INTEREST IN PHARMACEUTICAL policy issues. The July 9 announcement by putative Democratic Presidential nominee Bill Clinton that he has chosen Sen. Gore (D-Tenn.) as his running mate matches a vice presidential candidate with FDA expertise with a presidential contender who has staked out a position on drug pricing. While Gore has focused primarily on environmental and foreign policy issues in the past year or two, his interest in health care policy dates back to his days in the House of Representatives. For example, FDA Commissioner Kessler was the first commissioner to be confirmed by the Senate under provisions of a Gore-authored law enacted in 1988 that requires such confirmation. The legislation was developed in the midst of debate on whether FDA should be an independent agency so that agency regulations would be less subject to review and hold-ups by HHS and the Office of Management & Budget. The measure also created statutory authority for FDA. During the 1990 Kessler confirmation process, Gore highlighted his interest in FDA's development of biotechnology policy. During his congressional tenure, Gore has through hearings or legislation addressed issues including applications of human gene therapy, release into the environment of genetically-engineered organisms and biomedical ethics. The 44-year old junior senator from Tennessee currently is a member of the Senate committees on Commerce, Science and Transportation; Armed Services; and Rules. Gore is also on the Joint Economic Committee. A native of Carthage, Tenn., Gore was first elected to the House in 1976 and moved to the Senate in 1984, following in the footsteps of his father whose tenure in the House and the Senate spanned more than 30 years. While in the House, Gore joined with Rep. Scheuer (D-N.Y.) to propose establishment of a blue-ribbon panel, subsequently headed by Tulane University pharmacology professor Gilbert McMahon, to review FDA regulatory policies. He also held hearings to examine allegations of favoritism in FDA's review of contact lens products. One of Gore's more notable legislative achievements is the authorship of the 1984 National Organ Transplant Act, which is intended to encourage donation of organs for transplantation and improve the system of allocation. Gore later supported Medicare coverage of immunosuppressive drugs for organ transplantation patients. Gore's work on the transplant act foreshadowed his later interest in health care technology assessment and the types of outcomes research now sponsored by the HHS Agency for Health Care Policy and Research. The transplant law gives Medicare authority to limit reimbursement to providers who have a demonstrated success rate with transplant procedures. More recently, Gore has been a vocal opponent of Oregon's request for a Medicaid waiver allowing the state to implement a list prioritizing the types of medical conditions for which treatment will be covered. The request is still under review by the Bush Administration and Congress. Presidential candidate Clinton's comments on drug pricing include endorsement of fellow Arkansan Sen. Pryor's (D) S 2000, which would trim Sec. 936 Puerto Rico tax credits for pharmaceutical companies whose product prices rise faster than general inflation ("The Pink Sheet" Feb. 3, In Brief). Clinton also has said he would retain R&D tax credits but would try to limit any use of those credits for activities such as marketing. While Gore has never drafted legislation of his own to address pharmaceutical pricing, he did express interest in examining pricing issues during appearances before trade groups in 1988. In his own 1988 presidential run, Gore supported expanded Medicaid benefits for pregnant women and children and the establishment of a basic scope of health benefits that employers must provide.

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

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