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Study Group: U.S. Department of Agriculture Experts: Legal, Economic, and Regulatory Affairs

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.

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Leading Experts in this Study Group

Jeff Stier, Associate Director, American Council on Science and HealthJeff Stier

Associate Director
American Council on Science and Health
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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,...

Kyd Brenner

Partner
DTB Associates, LLP
What is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.

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...

Kevin Brosch

Partner
DTB Associates, LLP
What is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.

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...

Paul Drazek

Partner
DTB Associates, LLP
What is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.

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...

Frederick McClure

Partner
SONNENSCHEIN, NATH & ROSENTHAL, LLP
What is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.

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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GLG NewsSM Analyses by this Study Group's Leading Experts(?)

Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.

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.

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Members in this Study Group include these company types:

  • Policy or Political Consulting Firm
  • Professional or Industry Association*
  • Law Firm (general practice/large)
  • Lobbying Firm
  • Academic Institution*
  • Advocacy Group or Issue Focused
  • Consulting Firm
  • Consulting Firm (ei)
  • Biofuels
  • Meat Products

Members in this Study Group often have these job titles:

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  • President
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  • Owner
  • Professor
  • Economist
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  • Vice President
  • Chief Executive Officer
  • Policy Analyst