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

Representatives of the biotechnology industry are meeting with Rep. Waxman (D-Calif.) to forge export legislation limited to biotech products. The negotiations began after efforts toward a broader pharmaceutical export bill came to an apparent dead end in the House. With the remaining legislative days in the congressional calendar dwindling and Waxman and pharmaceutical industry negotiators at an impasse over the issue of a worldwide drug labeling survey, the biotech industry is seeking to negotiate narrower legislation to permit the export of genetically engineered medical products prior to FDA approval. Although biotech companies initially made the decision to join with the pharmaceutical industry in seeking export reform legislation, they reportedly have considered pursuing a bill independent from the drug manufacturers. Earlier in the year there was concern that the Pharmaceutical Manufacturers Association would actively seek to quash attempts to enact biotech-specific export legislation. However, PMA has reportedly indicated it will not try to block such a measure. Waxman has been publicly sympathetic to the biotech industry's need for relief from export restrictions. At a hearing on the issue before his Health Subcommittee last spring, Waxman said he hoped that Congress will "be able to address those very real problems" facing biotech firms ("The Pink Sheet" May 5, p. 10). The key sponsors of the export bill in the Senate, Hatch (R-Utah) and Kennedy (D-Mass.) are watching the House action. As of Oct. 10, Hatch was reportedly waiting to see whether the biotech bill could pass the House before deciding. The major stumbling block to a drug export bill in the House was Waxman's persistence on a provision to require PMA cooperation in the labeling survey while PMA rejected the idea from the start. In an attempt to salvage the legislation, Sen. Kennedy proposed that industry not be required to cooperate beyond an initial submission of labels used worldwide. Pharmaceutical firms indicated that the measure should stipulate that they should not have to justify or present evidence to support country-to-country differences in labeled indications or warnings for their products. PMA also rejected any proposals that would lead to independent judgments about the propriety of such differences.

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