Our Website Uses Cookies
We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.
For more information, please contact us or consult our Privacy Notice.
Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
Michael Stern advises pharmaceutical companies on their most complex, high-stakes FDA regulatory issues. With over 15 years of experience, he frequently counsels innovative drug and biotechnology companies on Hatch-Waxman, biosimilars, and orphan drug issues, including regulatory exclusivity and life-cycle management strategies. Clients consult Mr. Stern on a broad range of R&D-related issues, including strategies for application submission, engagement with FDA, qualifying for expedited programs and priority review vouchers, and Risk Evaluation and Mitigation Strategies (REMS). Mr. Stern joined Covington from FDA, where he served as an Associate Chief Counsel from 2010 to 2016.
While at FDA, Mr. Stern advised FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) on regulatory issues including the approval of complex generic drugs, citizen petitions, biosimilars, REMS, imports, and user fees. Mr. Stern also worked with the U.S. Department of Justice (DOJ) to prosecute enforcement actions and defend FDA against legal challenges to agency decisions.
Mr. Stern speaks frequently on FDA regulatory issues, both in the U.S. and abroad.
Hatch-Waxman
- Developed life-cycle management strategies for drug and digital health products.
- Advised innovative pharmaceutical companies on exclusivity-related issues.
- Prepared citizen petitions for innovative companies addressing bioequivalence methods, labeling carve-outs, active ingredient sameness, and other abbreviated new drug application (ANDA) approval issues.
- Advised pharmaceutical companies on section 505(b)(2) issues.
- Prepared comments and advised trade association and pharmaceutical industry clients on FDA’s Drug Competition Action Plan.
Biologics and Biosimilars
- Advised innovative clients on life-cycle management, reference product exclusivity, and nonproprietary naming.
- Prepared comments on FDA’s Biosimilars Action Plan and significant FDA draft guidance documents, including guidances on biosimilar labeling, transition products, and interchangeability.
Pharmaceutical Research and Development
- Advised pharmaceutical companies on orphan-drug issues, expedited programs (including breakthrough therapy and fast track), and priority review vouchers; assisted in securing related designations from FDA.
- Developed strategies for application submission and selection of an appropriate approval pathway.
- Advised pharmaceutical companies on interactions with FDA during the application review process, including through formal dispute resolution.
- Advised drug developers on REMS and access to samples of innovative products by follow-on developers.
Memberships and Affiliations
- Food and Drug Law Institute: Publications Peer Review Committee; Curriculum Advisor for Training Courses
Previous Experience
- U.S. Food and Drug Administration, Associate Chief Counsel (2010-2016)
Regulation of Biological/Drug Development
March 10, 2021, Food and Drug Law Institute (FDLI) Introduction to Biologics and Biosimilars Law and Regulation, Washington, DC
The U.S. Patent Linkage System: Strategic and Practical Considerations
November 12, 2020, USPTO/FDA―CNIPA/NMPA Joint Seminar
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
June 27, 2020
WASHINGTON—Covington represented Piramal Enterprises Limited (PEL) in the sale of a 20% stake in Piramal Pharma Limited (Piramal Pharma), a wholly owned subsidiary of PEL that will contain its pharmaceutical businesses, to CA Clover Intermediate II Investments, an affiliated entity of CAP V Mauritius Limited, an investment fund managed and advised by affiliated ...
Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process
November 15, 2019, American Conference Institute's Life Sciences IP Due Diligence Summit, Boston, MA
Regulation of Biological/Drug Development
October 1, 2019, Food and Drug Law Institute (FDLI) Introduction to Biologics and Biosimilars Law and Regulation, Washington, DC
Preparing for the Worst: Adverse Event Monitoring, Pharmacovigilance, Risk Management, and Recalls
September 20, 2019, American Conference Institute's FDA Boot Camp, Boston, MA
Regulation of Biological/Drug Development
July 23, 2019, Food and Drug Law Institute (FDLI) Introduction to Drug, Biologics, and Biosimilars Law and Regulation, Boston, MA
Understand Critical Regulatory Pathways for Success in Orphan Product Development
June 14, 2019, CBI Rare Disease Innovation and Partnering Summit, Boston, MA
FDA Regulation of Drug Development and Approval
June 11, 2019, Seton Hall University School of Law, U.S. Healthcare Compliance Certificate Program, Newark, NJ
Biologics and Biosimilars
April 12, 2019, Food and Drug Law Institute (FDLI) Introduction to Drug Law and Regulation, Washington, DC
Biologics and Biosimilars
November 8, 2018, Food and Drug Law Institute (FDLI) Introduction to Drug Law and Regulation, Washington, DC
October 29, 2018
President Trump on October 24 signed the SUPPORT for Patients and Communities Act (H.R. 6), which together with the Patient Right to Know Drug Prices Act (S. 2554), signed October 10, expands the scope of pharmaceutical product-related agreements subject to filing requirements under subtitle B of Title XI of the Medicare Prescription Drug, Improvement, and ...
New Drug Research and Development
July 24, 2018, Food and Drug Law Institute (FDLI) Introduction to U.S. Drug Law and Regulation, South San Francisco, CA
November 8, 2017, Covington Alert
On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services (“CMS”) released two final rules addressing changes to Medicare Part B reimbursement policies for biosimilars. These final rules—for the Medicare Physician Fee Schedule (“PFS”) and the Hospital Outpatient Prospective Payment System (“OPPS”)—announced new directions for both the coding and ...
Abbreviated New Drug Applications, 505(b)(2) Applications, and Patent and Exclusivity Issues
November 2, 2017, Food and Drug Law Institute (FDLI) Introduction to U.S. Drug Law and Regulation, Washington, DC
Hatch-Waxman Overview and Case Studies
October 25, 2017, Tsinghua University, Beijing, China
Biosimilar Biological Products
October 4, 2017, Food and Drug Law Institute (FDLI) Introduction to Biologics and Biosimilars Law and Regulation, Washington, DC
Advertising and Promotion of Biological Products Including Biosimilars
September 26, 2017, Food and Drug Law Institute (FDLI) Advertising and Promotion Conference, Washington, DC
New Drug Research and Development
June 14, 2017, Food and Drug Law Institute (FDLI) Introduction to Drug Law and Regulation, Boston, MA
Biosimilars in the United States: Current and Emerging Issues
November 10, 2016, Asia-Pacific Economic Cooperation (APEC) Biotherapeutics Program, Seoul National University, Seoul, Korea
Biologics and Biosimilars
November 3, 2016, Food and Drug Law Institute (FDLI) Introduction to Drug Law and Regulation, Washington, DC
Assessing Biosimilarity: Insights into FDA’s Legal and Scientific Approach
September 14, 2016, APEC Biotherapeutics Program, Northeastern University, Burlington, MA