Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval process and patent and exclusivity issues related to the Hatch-Waxman Act. Mr. Beaver is a member of the firm’s Government & Public Policy and FDA Practices, and the Food & Beverage Industry and Life Sciences Industry Teams.
Mr. Beaver also has significant experience in FDA and Hatch-Waxman cases involving drug approvals, withdrawals and other types of litigation involving FDA regulated products.
REPORTED AND OTHER CASES
- Zeneca, Inc. v. Shalala, 213 F.3d 161 (4th Cir. 2000). Intervened on behalf of generic drug maker where plaintiff was seeking to have agency withdraw generic approval. Obtained summary judgment dismissal of case at district and appellate level.
- Pharmanex, Inc. v. Shalala, 221 F.3d 1151, (10th Cir. 2000). Filed Amicus brief for National Organization of Rare Disorders, won reversal of adverse district court decision.
- Teva Pharmaceuticals USA, Inc. v. FDA, 182 F. 3d 1003 (D.C. Cir. 1999). Successfully sued the agency to recognize the dismissal of a declaratory judgment action as a "court decision" under Hatch-Waxman statute and approve client’s drug product.
- Pfizer, Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999). Intervened on behalf of generic drug maker where plaintiff was seeking to have agency withdraw generic approval. Obtained summary judgment dismissal.
ADMINISTRATIVE LITIGATION
- In the Matter of: Enrofloxacin for Poultry Withdrawal of Approval for New Animal Drug Application NADA 140-848, FDA Docket 00N-1571 (2003). Defended client in animal drug withdrawal process.
Mr. Beaver was named a 2012 BTI Client Service All-Star, one of only 272 attorneys so honored throughout the United States, as a result of unprompted positive feedback from BTI’s interviews with nearly 300 corporate counsel from Fortune 1000 companies. He was also selected for inclusion in The Best Lawyers in America© since 2015 for his work in food and beverage law. In 2015, Mr. Beaver was recognized by The Legal 500 for his work in health care – life sciences.
Mr. Beaver earned his J.D. from Georgetown University Law Center in 1997. He graduated cum laude in 1994 from the University of Arizona with a Bachelor of Arts degree in interdisciplinary studies.
Mr. Beaver is admitted to practice in the District of Columbia.
He is a frequent speaker at the Food and Drug Law Institute events and the author or co-author of the following published articles:
- “Ten Things That Health Care Lawyers Should be Thinking About,” Association of Corporate Counsel, December 16, 2014
- Book Chapter: "Recent Developments in Food and Drug Law," “Natural” Claims: The Current Legal and Regulatory Landscape, Aspatore Publishing, 2013
- "Trends in ‘All Natural’ Class Actions," Law360, November 2011
- "Certifying to Medical Necessity Under FDA," Law360, April 2011
- "New Legal Pathway for Biosimilars Creates Opportunities and Challenges for Biological Manufacturers – A Guide to the Legislation," Bloomberg Law Reports, August 2010
- "The FDA Stance on High-Fructose Corn Syrup," Law360, October 2009
- "The Future of Drug and Biologics Approvals: Will Congressional Legislation Change the Landscape of Hatch-Waxman," BNA Health Care Policy Report, September 2002
- "Fundamentals of Law and Regulation: An in-depth look at the 1997 Food and Drug Administration Modernization Act of 1997"