Peter V. Lindsay is a partner in the Investigations and White Collar Defense practice, based in the firm’s Washington D.C. office.
Mr. Lindsay focuses his practice on advising clients regarding a range of FDA regulatory, compliance, and enforcement issues, including those related to manufacturing (cGMPs/QSR) and other post-approval requirements. He has conducted significant internal reviews for life science companies addressing promotional activities, supplier management and supply chain risks, manufacturing activities, and safety reporting. His practice also spans crisis management strategy and helping companies address recalls and other significant market actions. He has advised companies in government investigations involving criminal and civil issues regarding alleged violations of the federal Food, Drug, and Cosmetic Act, the federal Anti-Kickback Statute, and the federal False Claims Act.
Mr. Lindsay has defended many clients across the FDA-regulated product spectrum, including medical devices, pharmaceutical manufacturers (API and drug product), and biotech companies. This support includes advising companies on many aspects of FDA regulatory and enforcement actions related to manufacturing quality inspections, warning letters, recalls, seizures/injunctions, and consent decrees. He also supports corporate transactions by conducting regulatory due diligence on FDA-related matters.
- The Legal 500, Healthcare: Life Sciences (2021)
- The Legal 500, Dispute Resolution - Corporate Investigations and White-Collar Criminal Defense: Advice to Corporates (2021)
- Duke University School of Law, J.D. (magna cum laude), 2003
- Duke University, M.A., 2003
- Brigham Young University, B.A. (summa cum laude), 2000
GMP/Quality System Regulation (QSR) Enforcement and Compliance
- Advised pharmaceutical API company on developing comprehensive remediation plans to address Warning Letters related to multiple international sites.
- Represented Asia-based pharmaceutical manufacturer to respond to significant FDA Warning Letter raising data integrity issues and on related investigation and remediation plan.
- Led comprehensive review of supplier management processes and controls for multinational medical device manufacturer.
- Conducted risk assessment of manufacturing site’s data integrity controls for API facility located in India.
- Advised pharmaceutical company in preparation for an FDA inspection of its drug safety reporting program and processes.
- Conducted internal review for medical device manufacturer responding to whistleblower allegations of GMP and data integrity violations.
- Conducted global review of controls related to data management at multiple European and Asian manufacturing facilities for large pharmaceutical company.
- Led review of controls and practices related to the management of deviations, out-of-specification investigations, complaints, and CAPAs at multiple global sites of pharmaceutical company.
- Assisted medical device company in responding to an FDA Warning Letter for GMP issues, developing corrective action plan, and meeting with FDA District Office; Warning Letter was successfully closed out in less than one year.
- Advised U.S.-based medical device company on response to FDA Warning Letter, execution of related product recalls, and development of quality system remediation plan for imaging device.
- Assisted European-based food manufacturer in responding to FDA inspection observations.
- Conducted GMP readiness reviews and/or prepared many manufacturing sites for FDA inspections in the United States, Canada, Mexico, China, India, Japan, Thailand, Belgium, Croatia, France, Germany, Italy, and other locations for pharmaceutical, medical device, and biotech companies.
Regulatory and Enforcement Counseling
- Advised multinational pharmaceutical company in criminal and civil investigation which resulted in DOJ declination to intervene in a whistleblower action related to allegations of off-label promotion.
- Assisted pharmaceutical manufacturer with review and remediation planning related to device tracking issues.
- Conducted an internal review focusing on potential off-label marketing practices by field sales representatives for pharmaceutical manufacturer.
- Led internal reviews for global pharmaceutical manufacturer regarding field promotional practices, including issues related to product reimbursement and potential off-label promotion.
- Conducted FDA-related due diligence for corporate transactions related to the purchase of multiple pharmaceutical API manufacturing sites.
- Advised pharmaceutical manufacturer in preparing for post-market safety inspections and related communications with FDA.
- Assisted pharmaceutical manufacturers with issues related to drug sampling.
- 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
- Panelist, FDLI Enforcement, Litigation, and Compliance Conference, Continuing Impact of FDA's Inspection Approach on Industry and What Happens Next, December 9, 2021
- Speaker, FDLI Introduction to Drug Law, GMPs and Manufacturing, November 10, 2021
- Warning Letters and What They Mean for Healthcare Lending, Peter Lindsay and Stacy Hopkins, Medical Device and Diagnostic Industry (MDDI), July 9, 2021
- Panelist, FDLI Annual Conference, Supply Chains in a Post-Pandemic World, May 19, 2021
- Key Considerations for Senior Executives Related to Quality Culture, Peter Lindsay and Nathan Sheers, Pharmaceutical Executive, March 9, 2021
- 3 Things To Know About FDA's Evolving Drug Inspections, Peter Lindsay and Nathan Sheers, Law360, Feb. 19, 2021
- Going Up the Chain: Escalation of Significant Issues in Life Sciences Companies, Peter Lindsay, Nathan Sheers, and Jesselyn Pe, FDLI Update Magazine, Spring 2021
- Presenter, "Regulation of Drug Manufacturing," Introduction to U.S. Drug Law and Regulation, Food and Drug Law Institute (Apr. 13, 2018)
- Trainer, DIA course for foreign regulators on "Drug GMPs and Inspections – A Legal Perspective" (March 2013)
- Presenter, DIA Webinar on "Pharmacovigilance and Social Media" (January 2010)
- Presenter, FDA CDER In-House Training Program on "Introduction to Drug Law and Regulation: Regulation of Drug Manufacturing" (Dec. 2009)