Nathan Sheers is an FDA Regulatory and Enforcement partner at Paul Hastings, based in the firm’s Washington D.C. office. Mr. Sheers concentrates his FDA practice on civil, criminal, and regulatory matters. He has led numerous internal corporate investigations involving allegations of FDA violations by global companies in the pharmaceutical, biotech, and medtech industries, including recombinant and gene therapy technologies. Mr. Sheers has defended clients in related civil and criminal proceedings, including grand jury inquiries, whistleblower lawsuits, and employment matters. Mr. Sheers’ practice also supports products throughout their regulatory lifecycles, including product development, clinical practice, product manufacturing, and post-marketing reporting requirements, including field alert reports, medical device tracing, adverse event reports, and product removals, including recalls. Mr. Sheers helps clients prepare for FDA submissions and related meetings, routine and for cause inspections, FDA observations and enforcement action responses, and Regulatory Meetings. Mr. Sheers also regularly counsels clients on effective oversight and compliance systems, the identification of regulatory risk, and proactive steps for mitigating risk.
- The Legal 500, Healthcare: Life Sciences (2021)
- The Legal 500, Dispute Resolution—Corporate Investigations and White-Collar Criminal Defense: Advice to Corporates (2021)
- Columbia University School of Law, J.D. (Harlan Fiske Stone Scholar; Charles Bathgate Beck Prize recipient; Chief Articles Editor, Columbia Law Review), 1992
- West Virginia University, B.A., 1989
- Assisted global pharmaceutical company in successfully addressing an FDA Warning Letter on clinical trial practices, resolving GMP issues at several manufacturing sites, and conducting risk assessments for various company initiatives involving heightened regulatory focus, including aseptic manufacturing and data integrity.
- Partnered with global pharmaceutical company to conduct organizational reviews of the Medical and the Manufacturing groups’ Quality Management Systems.
- Led legal team and supporting consultants conducting an internal investigation into research practices at a global vaccine manufacturer; presented findings and remediation to CBER’s Office of Compliance, resulting in no agency action.
- Led legal team and supporting medical consultants conducting an internal investigation into the clinical trial practices of a company’s clinical research facilities; presented findings to CEO and leadership team and made recommendations for handling issues with relevant FDA offices.
- Supported global pharmaceutical manufacturer on manufacturing site investigations, FDA inspection observations, data integrity reviews, and the oversight of regulatory obligations relating to combination products.
- Led legal team and supporting forensic consultants conducting a significant data integrity investigation at a pharmaceutical company executing a $4 billion merger; regularly briefed Management and Supervisory Boards of client on investigation progress; testified at trial regarding the investigation and its conclusions; and the court found for the first time under Delaware law that the merger could be unwound as a result of a Material Adverse Event under the merger agreement.
- Conducted internal investigation, in cooperation with U.S. Attorney’s Office, of data integrity concerns within the Quality Control laboratory of a foreign manufacturing site; presented findings to U.S. Attorney’s Office’s Health Care and Government Fraud Unit, resulting in declination.
- Advised global vaccine manufacturing regarding Warning Letter responses and led team supporting remediation, inspection readiness, interviewee preparations, FDA inspection monitoring and support, and responses to FDA observations, resulting in return to acceptable compliance status.
- Advised global pharmaceutical manufacturer regarding gene therapy working viral seed stock and treatment to satisfy FDA concerns raised during inspection and in Complete Response Letter.
- Conducted multiple reviews of aseptic manufacturing and related personnel practices in order to provide recommendations for remediation, continuous improvement, risk mitigation, and successful inspection.
- Assisted global pharmaceutical company in successfully addressing an FDA Warning Letter on post-marketing pharmacovigilance practices and promptly integrating reportable information from global sources.
- Successfully defended numerous False Claims Act qui tam cases filed against global life sciences companies, many based on alleged FDA violations.
- Considerations When Using Digital Health Technologies in Clinical Investigations - January 4th, 2022
- Key Legal and Regulatory Considerations Related to Microbiological Risks - October 6th, 2021
- Looking Around the Corner: Prepare for Increasing FDA Oversight and Review - August 2nd, 2021
- Updated FDA Guidance on Sponsor Responsibilities for IND Safety Assessments - June 29th, 2021
- Key Points Related to the FDA’s Guidance on Servicing Versus Remanufacturing Medical Devices - June 24th, 2021
- FDA Releases Long-Anticipated Guidance for Remote Interactive Evaluations of Drug Manufacturers - April 16th, 2021
- FDA’s New Guidance on Cell and Gene Therapy Recommends Assessment of COVID-19 Transmission Risks - February 4th, 2021
- Watching the Backdoor: Planning for and Responding to a Cybersecurity Incident at Medical Device Companies – An FDA Perspective - November 24th, 2020
- FDA Manufacturing Challenges for Gene and Cell Therapy Developers - October 19th, 2020
- Carpe Diem: A Holistic Strategy for Assessing Supply Chain Compliance Risk in a COVID-19 World - September 28th, 2020
Engagement & Publications
- Guest Lecturer, FDLI course for FDA Employees, "Drug Manufacturing Enforcement and Compliance" (multiple times)
- Guest Lecturer, DIA course for visiting China FDA inspectors, "Drug GMPs and FDA Inspections" (multiple times)
- Editor, False Claims Act content, "Health Care Fraud: Enforcement and Compliance" (Law Journal Press)