Council Members in this Study Group: 28
This study group may include professors, attorneys, former regulatory officers, and consultants knowledgeable on topics such as law and litigation issues, lobbying, policy and government, elections, antitrust, immigration, intellectual property, and legislation, among others.
Leading institutions connect with members of this Study Group through GLG
Jeff StierAssociate Director
American Council on Science and Health![]()
Jeff Stier is an Associate Director at the American Council on Science and Health, a public health and consumer advocacy organization dedicated to promoting sound science in public health. In this position, he is responsible for government relations,...
Partner
DTB Associates, LLP![]()
Kyd Brenner is a Partner at DTB Associates in Washington, DC, where he focuses on international food and feed safety and standards, trade in products of modern biotechnology and the interface between science and trade policy. Previously, he was Vice President...
Partner
DTB Associates, LLP![]()
Kevin Brosch is a Partner at DTB Associates in Washington, DC, where he specializes in international and agricultural policy and law. Previously, he served as special advisor on international trade to the Senate Committee on Agriculture Nutrition and...
Partner
DTB Associates, LLP![]()
Paul Drazek is a Partner at DTB Associates in Washington, DC, where he has over 29 years of experience in the field of international trade policy and an extensive knowledge of domestic and international trade rules and practices. Previously, Mr. Drazek...
Partner
SONNENSCHEIN, NATH & ROSENTHAL, LLP![]()
Fred McClure is Partner at Sonnenschein Nath & Rosenthal in Washington, DC, where he has a national reputation for excellence and extensive legislative experience with Congress. He also has broad advocacy experience with the Executive Branch of the U.S....
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Black Box Warnings: Not Blacklist Warnings
August 6, 2009
UPDATE: FDA: Requires Stronger Warnings For TNF Blocker Drugs | online.wsj.com
The risk highlighted by this new bold warning was a known risk. The questions are: How should physicians and patients respond to a new warning rather than new risks? What are the risks of black box warnings?What are the implications for Johnson & Johnson (JNJ), which makes Remicade and Simponi, Abbott (ABT), maker of Humira and Amgen (AMGN) and Wyeth (WYE), co-marketers of Enbrel, as well as UCB SA's (UCB.BT) maker of Cimzia?
FDA Warning On E-Cigs is Tone Deaf
July 22, 2009
FDA Questions Safety, Quality of Electronic Cigarettes | blogs.wsj.com
Even major tobacco companies are now considering E-cigarettes, but the FDA is dead set against them. This is a harbinger of how FDA will use their new authority to regulate tobacco.
Swine Flu Presents Opportunities for Vaccine Makers And Others
July 21, 2009
Financial Times FT.com | www.ft.com
A relatively small group of pharmaceutical companies includingGlaxoSmithKline, Roche and Sanofi-Aventis which make vaccines have the market cornered when it comes to the front lines of the global fight against swine flu. But well positioned smaller companies could benefit
Sometimes, Breast Cancer Legislation Could Do More Harm Than Good
July 14, 2009
Detecting a Bad Breast Cancer Bill | www.rollcall.com
New legislation calls for more widespread genetic testing for breast cancer as well as other types of breast cancer screening.
Potential Good News for Biosimilars
July 14, 2009
US Senate panel backs 12-year biotech drug shelter | www.reuters.com
This is good news for Amgen Inc (AMGN.O) and Roche Holding AG (ROG.VX) as longer exclusivity passes a major Senate hurdle. While some are calling this a defeat for "generic" (biosimilar) makers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O), it isn't all bad news.