Overview

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. Nate is a member of the firm’s Government Solutions and FDA Practices, and the Food & Beverage and Life Sciences Industry Teams. He is also co-chair of the Food & Beverage Industry Team.

Nate also has significant experience in FDA compliance and enforcement issues including 483s, Warning Letters and Consent Decrees.

Representative Enforcement Experience

  • U.S. v. Kabco Pharmaceuticals, Inc. - 2:12-cv-03468-JFB-ETB (ED NY 2012). Successfully negotiated with FDA to permit the reopening of dietary supplement manufacturing company after consent decree shut down
  • U.S. v. Wholesome Soy Products, Inc. et al. - 1:15-cv-02974 (ND IL 2015)
  • U.S. v. American National Red Cross, - 1:93-CV-00949 (D.D.C. 2015). Successfully negotiated with FDA for the termination of a longtime consent decree
  • U.S. v. Wa Heng Dou-Fu & Soy Sauce Corp., - 2:16-CV-01358 (ED CA 2016)

Transactional Experience

Nate regularly advises clients in M&A transactions involving health care and life sciences companies. His involvement has included due diligence and diligence assessments, negotiations of regulatory issues in asset and purchase agreements, including reps and warranties, and post-transaction licensure issues.

Representative Transactions

  • Represented a biotherapeutics company in diligence and prospectus drafting for IPO (2018)
  • Represented a spinal device company in diligence and prospectus drafting for an IPO (2018)
  • Represented purchaser in regulatory diligence and purchase of medical device contract manufacturer (2018)
  • Represented a leading pharmaceutical laboratory in the acquisition of HemoSonics LLC, a company specialized in the development of innovative Point-of-Care testing solutions based in Charlottesville, VA (2017)
  • Represented G&W Laboratories in divestiture acquisition of ANDAs from drug manufacturers Gavis Pharmaceutical LLC and Novel Laboratories (2016)
  • Represented Auven Therapeutics in regulatory aspects of sale of Ocular Technologies Sarl including SecieraTM (OTX-101) to Sun Pharma (2016)
  • Representation of a leading food manufacturer in regulatory aspects of acquisition of Corn Fields, Inc. (2016)
  • Representation of a Fortune Global 500 health care distribution company in regulatory aspects of acquisition of the Harvard Drug Group (2015)

Telemedicine and Digital Health

Nate advises companies in the telemedicine space on federal and state laws governing the prescribing of prescription including controlled substances via telemedicine. He has advised on state and federal regulation of controlled substance prescribing, including state medical and controlled substance licensure, federal DEA controlled substance registrations, as well as requirements to create a valid prescriber-patient relationship.

Digital Medicine

Nate has represented companies in the digital health space in complying with FDA requirements and determining when FDA jurisdiction is not present.

Recognition

Nate has been selected for inclusion in The Best Lawyers in America© since 2015 for his work in the area of food and beverage law (2015-2019) and in the area of FDA law (2018-2019). He 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. In 2015, Nate was recognized by The Legal 500 for his work in health care – life sciences.

Education

Nate 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.

Admissions

Nate is admitted to practice in the District of Columbia.

Publications and Presentations

He is a frequent speaker at the Food and Drug Law Institute events and the author or co-author of the following published articles:

  • Presenter, “Top 15 Mistakes a Life Sciences Start-Up Makes,” Maryland Tech Council Roundtable, May 7, 2019
  • “Agricultural Bioengineering and Food Manufacturing: Navigating the Regulatory Terrain,” FoodOnline (2018)
  • Panelist, “M&A Disruption in the Food & Beverage Sector – A Regulatory Guide to Navigating M&A Due Diligence & Pre-Screening,” FoodBev Exchange Conference (2018)
  • Panelist, “Immunotherapy at the Crossroads: Will Shifting Patent and Regulatory Trends Help or Hurt,” (2018)
  • Panelist, “Collaborating With the FDA: What Has Worked and What Hasn't?,” The 5th Annual Business of Personalized Medicine Summit (2018)
  • “FDA Marketing Exclusivity Periods Limited to Same Active Moiety,” PharmaPatents, September 7, 2017
  • “Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps,” Personalized Medicine Bulletin, March 20, 2017
  • “Can FDA Implement the BPCIA as the CAFC Suggested,?” PharmaPatents, July 21, 2016.
  • “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"