Contact: Brian Davis
202.833.6951
bdavis@healthlawyers.org
Outgoing FDA Counsel Urges Contact with Agency in
Interview with Health Lawyers
WASHINGTON, DC, February 13, 2009 - The American Health Lawyers Association (AHLA) recently released an interview with Gerald Masoudi, outgoing Chief Counsel of the U.S. Food and Drug Administration, discussing his accomplishments, thoughts on how and when to approach the Center and Counsel’s office, and advice for his replacement. AHLA is seeking public responses and perspectives on key issues facing FDA’s next chief lawyer, the role of the Counsel’s office, and other issues raised in the interview.
The interview, conducted in January 2009,is available on AHLA’s website. In the questions and answers, Masoudi characterized the finalization of the reprint guidance, the Changes Being Effected regulation, and the guidance on genetically engineered animals as some of the greatest accomplishments of his term. He also commended his office’s commitment to “deal with legal issues and to leave policy issues to others,” and advised the next Chief Counsel to continue the office’s focus on faithfully interpreting the law.
Masoudi urged companies with legal concerns to contact the Counsel’s office without fear of harming their long term relationship with the agency. He said, “I’ve never seen anyone punished for raising in good faith a genuine legal issue.” However, he also stressed the need to only bring legal and not scientific issues to the Counsel’s office, and advised companies to inform the Center before they bring their issue to the Counsel’s office.
The interview further covers Masoudi’s views about FDA warning letters, the challenges facing the agency, his office’s relationship with Congress and the Department of Justice, his future plans, and other issues.
The interview was conducted on January 26, 2009, by Marc Wilenzick, Esquire, Erika Lietzan, Esquire, and Stefanie Doebler, Esquire. Wilenzick, an assistant general counsel at Pfizer, and Lietzan, a partner with Covington & Burling, are co-chairs of the of the AHLA Life Sciences Practice Group's Regulatory Law Affinity Group. Doebler is an associate in the Food and Drug Group at Covington & Burling.
The full transcript can be accessed at AHLA’s website. Follow up comments of maximum 1,500 words are welcomed and should be sent electronically to Seth Levy, Publications Vice Chair for the Life Sciences Practice Group. Comments are being posted on the AHLA website as they are received. This commentary includes the most recent response from Dan Kracov from Arnold & Porter LLP and will soon feature BIO Deputy General Counsel Sandra Dennis’ response.
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The American Health Lawyers Association (AHLA) is the nation’s largest nonpartisan educational organization devoted to legal issues in the healthcare field. The Association’s 10,000 members practice in a variety of settings in the healthcare community. For information about our resources, publications, and educational offerings, visit www.healthlawyers.org or call (202) 833-1100.