Healthcare: Pharmaceutical/Medical Products Regulatory
USA Guide 2024 : District of Columbia
Band 3
Email address
[email protected]Contact number
+1 202 739 3000About
Provided by Morgan, Lewis & Bockius LLP
Morgan Lewis provides sophisticated, integrated, and cost-effective counsel to businesses and organizations across the full spectrum of the healthcare industry. Our healthcare provider clients include hospitals and health systems; long-term care, home health, and hospice providers; retail and specialty pharmacies; behavioral health providers; suppliers; distributors; physician practices; medical societies; and private equity and venture capital investors, as well as the vendors that support these providers.
Our team includes some of the most respected healthcare law practitioners in the United States and a number of former senior US government officials. Leveraging our lawyers’ intimate knowledge of the inner workings of the government’s executive branch, and the regulatory agencies most critical to healthcare businesses, we bring special insight and savvy to the complex challenges and opportunities that our healthcare industry clients confront in the post–healthcare reform era.
Chambers Review
Demonstrates extensive capabilities in health law compliance matters, including investigations and other regulatory challenges. Attracts a broad roster of clients, including healthcare service providers, pharmaceutical and biotech companies. Frequently acts on civil and criminal litigation, as well as representing private equity firms in high-value healthcare acquisitions. Offers notable expertise in advising on complex coverage and reimbursement issues. Also noted for its FDA regulatory capabilities.
Work Highlights
- Morgan Lewis represented Spire Orthopedic Partners in its partnership with Poughkeepsie.
Strengths
Provided by Chambers
"Morgan Lewis is an incredibly strong firm with a deep bench of excellent lawyers."
"Morgan Lewis is an incredibly strong firm with a deep bench of excellent lawyers."
Notable Practitioners
Howard Young offers impressive skills in complex fraud and abuse mandates, as well as advising on compliance and data privacy issues.
"Howard does really great work."
Kathleen Sanzo focuses on pharmaceutical and medical products regulatory matters, including genetic testing and innovative drug research.
"She has a strong practice."
"Kathleen is an extraordinary lawyer."
Albert Shay represents a range of healthcare clients, including prominent pharmaceutical companies, in complex FDA compliance matters, investigations and other regulatory issues.
"Albert is a very good lawyer."
Kathleen McDermott offers significant expertise in government investigations, particularly matters brought under the FCA. Her practice is complemented by her notable experience in the DOJ and US Attorney's Office.
"She is a very solid lawyer."
Dennis Gucciardo offers extensive knowledge to a wide range of pharmaceutical and device manufacturers on FDA regulations and compliance. He provides counsel on such issues as licensing agreements.
"Dennis is really proactive and extremely efficient."
Michele Buenafe serves as the firm's digital health team leader and healthcare industry team co-leader. Clients turn to her for FDA regulatory compliance and enforcement issues. She is especially known for her expertise in digital health-related issues.
Ranked Lawyers at
Morgan, Lewis & Bockius LLP
District of Columbia
Members
Provided by Morgan, Lewis & Bockius LLP
Andrew D. Ruskin
Joyce Cowan