Current Employment Position(s)

Partner

Lawyer Overview

In September 2005 Bob was named one of the leading food and drug lawyers in Washington, D.C. by Legal Times. In September 2008 he was again selected for inclusion in The Best Lawyers in America. He was also included in the 2009 edition of Washington D.C.'s Best Lawyers. Bob counsels clients, at both the federal and state level, on all aspects of product development and clinical investigation; product approvals involving New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications; and product promotion and post-approval requirements on a wide array of civil and criminal enforcement issues. He regularly counsels clients and conducts assessments of good clinical practices, good manufacturing practices and safety reporting, continuing medical education, research grants, scientific exchange and dissemination of medical information, and post-approval advertising and promotion conduct. He also counsels companies on all aspects of marketing and promoting over-the-counter drug products, as well as cosmetics. From 1981 to 1983, Bob served as the Executive Assistant to the Commissioner of the U.S. Food and Drug Administration (FDA). His government career with the FDA's Office of Chief Counsel began in 1975, when he served in several positions, including Associate Chief Counsel for Biologics, Associate Chief Counsel for Foods, and Associate Chief Counsel for Enforcement.

Areas of Practice

• Pharmaceutical and Biotechnology
• Food, Drug, Medical Device, and Agriculture
• Life Sciences

Bar Admissions

• Maryland
• District of Columbia

Honors and Awards

• Chambers USA, Health Care: Pharmaceutical/Medical Products Regulatory, 2006 - 2008
• Life Sciences: Regulatory/Compliance, 2007 - 2008
• Washington, D.C. Super Lawyers, Food and Drug Administration, 2007 - 2008
• PLC Which Lawyer? Handbook, Recommended Specialist in Life Sciences: Regulatory, 2006
• The Best Lawyers in America, 2006 - 2008
• Food and Drug Administration Award of Merit, 1982

Past Employment Positions

• Commissioner of the U.S. Food and Drug Administration (FDA), Executive Assistant

Education

• The George Washington University Law School, Washington, District of Columbia, 1972
  J.D.
  Honors: with honors
• University of Rochester, 1969
  B.A.

Address

555 Thirteenth Street, NorthWest
Washington, DC 20004

Phones

(202) 637-6969

Faxes

(202) 637-5910

Emails

Contact Us

Websites

http://www.hhlaw.com