FDLI Also Hosts Annual Enforcement, Litigation and Compliance Conference December 6-7
WASHINGTON, Dec. 2, 2011 /PRNewswire-USNewswire/ -- The Food and Drug Law Institute (FDLI) will present its Distinguished Service and Leadership Award December 6, 2011 at The Westin Georgetown in Washington, DC from 5:30-7:00 to four recognized leaders in the food and drug law community:
- F. Alan Andersen, PhD, President, FDA Alumni Association, and Director, Cosmetic Ingredient Review (CIR):
- Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, Food and Drug Administration (FDA);
- Robert P. Brady, Partner, Hogan Lovells; and
- Eugene M. Thirolf, Jr., Consultant
The four recipients will receive their awards at FDLI's Annual Holiday and Leadership Awards Reception. The awards recognize individuals from various areas of the food and drug law community for their notable service and leadership.
F. ALAN ANDERSEN, PhD is President of the Food and Drug Administration Alumni Association, and Director, Cosmetic Ingredient Review (CIR), an independent safety assessment program founded by the Personal Care Products Council (PCPC), with the support of FDA and the Consumer Federation of America. Prior to joining CIR in 1993, Dr. Anderson worked for 22 years in FDA's radiological health/medical devices area, conducting research and later directing the device standards program, the research and testing laboratories and the device evaluation office. He has chaired the ANSI Medical Device Standards Board, and is past president of the clinical lab standards group. At FDA, he received the PHS Superior Service Award, the FDA Award of Merit, an Employees EEO Recognition Award, and has since received the FDA Distinguished Alumni Award and has been made a Penn State Alumni Fellow. Dr. Anderson received his BS from Muhlenberg College and his MS and PhD from Penn State.
DEBORAH M. AUTOR is the Deputy Commissioner for Global Regulatory Operations and Policy, FDA. Ms. Autor's Directorate, one of four created in July 2011, includes the Office of Regulatory Affairs and the Office of International Programs. Previously, she served as the Director of the Office of Compliance at CDER, where she lead a staff of 300 public health professionals in promoting and protecting public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs. She also oversaw the Office's post-market surveillance and risk-based approaches to compliance and enforcement actions, guided the integration of Compliance's review of premarket data integrity and product quality inspections with the new and generic drug approval processes and lead the Office's strategic problem solving and planning activities. Ms. Autor has been with FDA since 2002 and previously served as Associate Director for Compliance Policy in the Office of Compliance. Her work was recently highlighted when she was awarded the 2011 Meritorious Executive Presidential Rank Award. She was named a 2010 finalist for the prestigious Service to America medal for the innovative and strategic action that she has taken to tackle the issue of marketed unapproved drugs. Before joining FDA, Ms. Autor was a Trial Attorney for seven years in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA. Prior to that, she practiced food and drug law at the firms of Weil, Gotshal & Manges and Buc Levitt & Beardsley. Ms. Autor obtained her BA from Barnard College of Columbia University and her JD, magna cum laude, from Boston University School of Law where she was an Article Editor on the Law Review.
ROBERT (BOB) P. BRADY is a Partner in the Washington, DC law firm of Hogan Lovells US L.L.P. He initiated the Hogan Lovells FDA drug/biotechnology practice group in 1995. Mr. Brady focuses his practice on pharmaceutical and biotechnology product law. He has been named one of the leading Food and Drug lawyers in Washington, DC by Legal Times (September 2005); included in The Best Lawyers in America (2010); included in the 2011 edition of Washington DC's Best Lawyers and received a "first tier" ranking from Chambers USA (2009; 2010; 2011). He counsels clients on all aspects of product development and clinical investigation; product approvals; 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, he served as the Executive Assistant to the Commissioner of the 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. Mr. Brady received a BA from the University of Rochester and a JD, with honors, from George Washington University Law School.
EUGENE M. THIROLF, JR. completed his service as the Director of the Office of Consumer Litigation, U.S. Department of Justice in May 2011. Since his retirement earlier this year, Mr. Thirolf has acted as a consultant on legal and regulatory issues involving the Consumer Product Safety Commission, FDA, and the Federal Trade Commission. In 1978, Mr. Thirolf joined the Department of Justice's Office of Special Investigations, which investigated and litigated cases involving Nazis and Nazi collaborators who illegally immigrated to the United States. Mr. Thirolf received an award for his successful prosecution of the Bishop Valerian Trifa case in 1980. He has also received the U.S. Department of Justice's second highest award, the Attorney General's Award for Distinguished Service. He came to the Office of Consumer Litigation in 1984 and was placed in charge of the government's prosecution of black market traffickers of prescription drugs in 1985. Mr. Thirolf was named Director of the Office in 1992. Between 1987 and 2007, Mr. Thirolf was the recipient of four FDA Commissioner's Special Citations. In 2011, he received the HHS Inspector General's Integrity Award. Previously, Mr. Thirolf served as a senior litigator with the Department of Justice's General Litigation and Legal Advice Section, prosecuting complex criminal cases. Mr. Thirolf received his BA in Philosophy from St. Louis University and his JD from its law school.
In addition to the Awards reception, FDLI is holding its annual Enforcement, Litigation and Compliance Conference December 6-7. Speakers will analyze game-changing developments and trends in compliance, enforcement and litigation and provide practical insight and guidance. Presenters include key FDA officials from the Office of Chief Counsel and Office of Regulatory Affairs; hands-on industry compliance, regulatory and legal officials; and experienced practitioners from the private bar. Howard Sklamberg, Deputy Associate Commissioner for Regulatory Affairs at FDA, will deliver the conference's keynote address.
The conference will feature sessions on FDA's new compliance mindset; updates from FDA's product centers; 2012 expectations and hot topics in civil enforcement; consent decrees and qui tam enforcement; 2012 expectations and hot topics in criminal litigation and investigative enforcement; avoiding monetary penalties; international enforcement; and more.
For more information on these events, visit www.fdli.org or call Michael Levin-Epstein, Editor-in-Chief, (202) 222-0897.
FDLI, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. FDLI's scope includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco.
SOURCE Food and Drug Law Institute