Experience
Enforcement Matters
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). Represented client in negotiation of consent decree.
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). Represented client in negotiation of consent decree.
Transactional Matters
Represented Power Plant Partners in its regulatory diligence and investment in Bobbie’s (2023)
Represented Archimed in its regulatory diligence and acquisition of Prollenium Medical (2021)
Represented Archimed in its regulatory diligence and acquisition of American Preclinical Services (2021)
Represented Archimed in its regulatory diligence and acquisition of Clinlogix (2021)
Represented Archimed in its regulatory diligence and acquisition of Syntactx (2020)
Represented Archimed in its regulatory diligence and acquisition of NAMSA (2020)
Represented Montagu Private Equity in its regulatory diligence and acquisition of the RTI Surgical OEM business (2019/2020)
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)
Career
Nathan A. Beaver is a seasoned FDA attorney known for responsive, big-picture advice. He counsels food and drug manufacturers, distributors, and retailers as they navigate federal and state agency compliance and regulatory issues. Whether clients are looking to move products through the FDA approval process, dealing with advertising or regulatory compliance issues, concerned with regulations related to telemedicine, involved in an M&A transaction, or facing FDA emergencies such as product recalls or inspections, Nate utilizes his deep understanding of the food and drug industry to help clients meet their long-term objectives.
A partner and food and drug lawyer with Foley & Lardner LLP, Nathan’s practice focuses on the representation of companies whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), U.S. Department of Agriculture (USDA) and 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. Nate also has significant experience in FDA compliance and enforcement issues including 483s, warning letters and consent decrees.
Nate’s FDA regulatory and compliance experience is valuable to health care and life sciences companies involved in mergers and acquisitions. He regularly advises clients in M&A transactions and IPOs, including due diligence and diligence assessments, negotiations of regulatory issues in asset and purchase agreements, including reps and warranties, and post-transaction licensure issues.
Nate counsels’ telemedicine and digital health companies on federal and state laws governing the prescription of controlled substances via telemedicine. He has advised on state medical and controlled substance licensure, federal DEA controlled substance registrations, as well as requirements to create a valid prescriber-patient relationship. Nathan has represented companies in the digital health space in complying with FDA requirements and determining when FDA jurisdiction is not present.
Nate also advises clients on the marketing of industrial hemp and CBD in food and beverage products as well as other FDA regulated products including cosmetics. Nate has advised retailers, manufacturers, and universities on compliance with the 2018 and 2014 Farm Bills relating to industrial hemp as well as state requirements for marketing hemp and CBD.
Co-chair of the firm’s Food & Beverage Industry Team and its Health Care & Life Sciences Sector – Medical Devices, Nate is a member of Foley’s Government Solutions and FDA Practices and its Cannabis Industry Team.