Mr. Michael Scott Labson

· The Best Lawyers in America (2010-2013)

· Chambers USA - America's Leading Business Lawyers (2008-2012) ("offers comprehensive services to clients on regulatory and legislative strategy and is a rising star in the practice")

· Washington DC Super Lawyer, FDA (2012)

· LMG Life Sciences, "Life Science Star" (2012)

· PLC Life Sciences, Which Lawyer? Highly Recommended for Regulatory (formerly FDA) - "He is one of the best known FDA practitioners from the younger generation of regulatory lawyers. Can advise on the whole spectrum of regulatory issues for both pharmaceutical and biotech clients" (2003-2012).

Pro Bono

· Mississippi v. Cory J. Maye. Represent defendant in capital murder case in Mississippi.

· State v. Rogers. Represented defendant in capital murder case in Florida.

· Kevin Smith. Represent DC inmate in federal custody seeking parole.

· Outside counsel to the International Biomedical Research Alliance, a nonprofit organization devoted to promoting the advance of biomedical research, including through support of the NIH/Oxford/Cambridge Biomedical Research Scholars Program.

· Coordinated initiative with Washington Lawyers' Committee for Civil Rights to review police misconduct cases in Prince George's County, and brought litigation in two individual cases.

· Represented Special Master in Vaughn G. litigation regarding special education services in the Baltimore City school system.

· Twelve John Does v. District of Columbia. Longstanding counsel for plaintiff inmate class regarding conditions at the former Lorton Central Facility.

Memberships and Affiliations

· Food and Drug Law Institute, Speaker

· Drug Information Association

Publications

· "Summary of FDA Advertising and Promotion Enforcement Activities - November 2012," Covington E-Alert (12/28/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (12/3/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (10/31/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - August 2012," Covington E-Alert (9/28/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - July 2012," Covington E-Alert (8/31/2012), Co-Author

· "Food and Drug Administration Safety and Innovation Act of 2012," Covington E-Alert (8/10/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - June 2012," Covington E-Alert (7/26/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - May 2012," Covington E-Alert (6/11/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - April 2012," Covington E-Alert (5/29/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - March 2012," Covington E-Alert (4/30/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - February 2012," Covington E-Alert (3/22/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - January 2012," Covington E-Alert (2/29/2012), Co-Author

· "2011 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (2/7/2012), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities - December 2011," Covington E-Alert (1/19/2012), Co-Author

· "FDA Releases Draft Guidance on Responding to Unsolicited Requests for Off-Label Information and Seeks Stakeholder Input on Scientific Exchange," Covington E-Alert (1/9/2012), Co-Author

· "How Should FDA Use Naming and Labeling to Communicate Information About Biosimilars?," Food and Drug Law Institute, Food and Drug Policy Forum (11/9/2011), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (6/3/2010), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (4/28/2010), Co-Author

· "2009 End-Of-Year Summary of DDMAC and APLB Enforcement Activity," Covington E-Alert (1/28/2010), Co-Author

· "Summary Of DDMAC And APLB Enforcement Correspondence - October 2009," Covington E-Alert (11/30/2009), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - September 2009," Covington E-Alert (10/30/2009), Co-Author

· "FDA Launches Reportable Food Registry," Covington E-Alert (9/15/2009), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - July 2009," Covington E-Alert (8/31/2009), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - June 2009," Covington E-Alert (7/27/2009), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - May 2009," Covington E-Alert (6/24/2009), Co-Author

· "Trends in DDMAC Enforcement Activity During the Bush Administration," Covington E-Alert (3/30/2009), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - February 2009," Covington E-Alert (3/17/2009), Co-Author

· "Summary Of DDMAC And APLB Enforcement Correspondence - January 2009," Covington E-Alert (2/17/2009), Co-Author

· "FDA Issues Final Guidance on "Good Reprint Practices," Covington E-Alert (1/21/2009), Co-Author

· "Summary Of DDMAC And APLB Enforcement Correspondence - December 2008," Covington E-Alert (1/15/2009), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - November 2008," Covington E-Alert (12/23/2008), Co-Author

· "Summary Of DDMAC And APLB Enforcement Correspondence - October 2008," Covington E-Alert (11/18/2008), Co-Author

· "Summary Of DDMAC and APLB Enforcement Correspondence - July 2008," Covington E-Alert (8/11/2008), Co-Author

· "PhRMA Issues Revised Code on Interactions with Healthcare Professionals," Covington E-Alert (7/11/2008), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - May 2008," Covington E-Alert (6/9/2008), Co-Author

· "FDA Issues Draft Guidance on the Distribution of Journal Articles and Reference Publications on Unapproved New Uses of Approved or Cleared Medical Products," Covington E-Alert (2/19/2008), Co-Author

· "Summary of DDMAC and APLB Enforcement Correspondence - January 2008," Covington E-Alert (2/12/2008), Co-Author

· "Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (1/18/2008), Co-Author

· "FDA Regulation of Biological Products," chapter 5 in The Pharmaceutical Regulatory Process (2nd ed.) (2008), Co-Author

· "Follow-on Biologics V. Hatch-Waxman: What the FOB Market Might Look Like," Regulatory Affairs Focus (Reprinted with Permission From Regulatory Affairs Professionals Society (RAPS) (January 2008), Co-Author

· "Summary of DDMAC Enforcement Correspondence - October 2007," Covington E-Alert (11/6/2007), Co-Author

· "Food and Drug Administration Amendments Act of 2007," Covington E-Alert (10/2/2007), Co-Author

· "Summary of DDMAC Enforcement Correspondence - August 2007," Covington E-Alert (9/5/2007), Co-Author

· "Summary of DDMAC Enforcement Correspondence - July 2007," Covington E-Alert (8/6/2007), Co-Author

· "Learned Intermediary Doctrine: Required By Fed Law?," Health Law 360 (7/17/2007), Co-Author

· "Summary of DDMAC Enforcement Correspondence - May 2007," Covington E-Alert (6/8/2007), Co-Author

· "CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007), Co-Author

· "Summary of DDMAC Enforcement Correspondence - March 2007," Covington E-Alert (4/4/2007), Co-Author

· "Summary of DDMAC Enforcement Correspondence - January 2007," Covington E-Alert (2/6/2007), Co-Author

· "Proposed Rules Regarding Requirements for Expanded Access to Investigational Drugs and Charging for Investigational Drugs," Covington E-Alert (1/26/2007), Co-Author

· "The Food and Drug Administration Amendments Act of 2007," Bio-Science Law Review (2006/2007), Co-Author

· "Summary of DDMAC Enforcement Correspondence," Covington E-Alert (12/7/2006), Co-Author

· "Summary of DDMAC Enforcement Correspondence," Covington E-Alert (11/6/2006), Co-Author

· "California Will Negotiate Drug Prices with Manufacturers in New Discount Drug Program," Covington E-Alert (10/9/2006), Co-Author

· "Summary of DDMAC Enforcement Correspondence," Covington E-Alert (10/9/2006), Co-Author

· "Western District of Texas Compounding Decision on Medical Center Pharmacy v. Gonzales," Covington E-Alert (9/27/2006), Co-Author

· "Proposed Rule Regarding Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs," Covington E-Alert (9/14/2006), Co-Author

· "Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (8/28/2006), Co-Author

· "New HHS Regulations Protect Arrangements Involving Health Information Technology," Covington E-Alert (8/24/2006), Co-Author

· "FDA Approval of Sandoz's 505(b)(2) Application for a Follow-On Recombinant Human Growth Hormone Product," Covington E-Alert (6/5/2006), Co-Author

· "Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach: A Divided D.C. Circuit Finds New Due Process Right for the Terminally Ill," Covington E-Alert (5/9/2006), Co-Author

· "The Impact of the Deficit Reduction Act of 2005 on Pharmaceutical Manufacturers," Covington E-Alert (3/3/2006), Co-Author

· "FDA Final Rule on Prescription Drug Labeling & Statement on Preemption of State Product Liability Laws," Covington E-Alert (1/27/2006), Co-Author

· "CMS Establishes PDP and MA Regions," Covington E-Alert (December 2004), Co-Author

· "Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Final Rule on ASP Calculation Methodology," Covington E-Alert (9/17/2004), Co-Author

· "Medicare Part D: USP Draft Model Guidelines and Public Comment Session," Covington E-Alert (August 2004), Co-Author

· "Average Wholesale Price Reform Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (12/11/2003), Co-Author

· "Drug Import Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington Report (12/8/2003), Co-Author

· "Prescription Drug Benefit Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (11/26/2003), Co-Author

· "The PhRMA Code: A New Roadmap for Industry-Physician Interactions," Virtual Mentor (7/1/2003), Author

· "The PhRMA Code: A New Roadmap for Industry-Physician Interactions," American Medical Ass'n Virtual Mentor (July 2003)

· "Pediatric Priorities: Legislative and Regulatory Initiatives to Expand Research on the Use of Medicines in Pediatric Patients," Journal of Health Care Law & Policy, Vol. 6 No. 1 (11/1/2002), Author

· "Raising Awareness of Regulatory, Legal, and Ethical Issues," Institute of Medicine, Rational Therapeutics for Infants and Children: Workshop Summary (National Academies Press) (2000)

· "The Washington Legal Foundation Decision," (7/30/1999), Author

Presentations and Speeches

· "Build More Effective Manufacturer-Sponsored Copayment Coupons/Coinsurance Assistance Programs," Webinar (11/13/2012)

· "Biosimilars: Regulatory Pathway & Non-Patent Exclusivity," American Conference Institute, 12th Advanced Forum on Biotech Patents, Boston, MA (11/30/2010)

· "New Controversies and Concerns Associated with Orange Book Listings and Labeling Strategies," American Conference Institute, 11th Annual Conference on Maximizing Pharmaceutical Patent Life Cycles, New York City (10/7/2010)

· "PDUFA 4: The Next User Fee Cycle," Windhover's FDA/CMS Summit for BioPharma Executives, Washington, DC (December 2005)

· "FDA's Drug Safety Initiatives," New Jersey Corporate Counsel Association, Bridgewater, NJ (11/21/2005)

· "The Debate on Generic Biologics: The Latest Legislative and FDA Developments and How They Will Impact the Future of Biotech Patents," American Conference Institute, 5th Advanced Forum on Biotech Patents, New York, NY (September 2005)

· "Drug Importation: State and Local Government Initiatives," HDMA Distribution Management Conference (6/16/2005)

· "The New Drug Approval Process: NDA Submission and Review," Food and Drug Law Institute, Introduction to Drug Law and Regulation, Washington, DC (February 2005)

· "Current Regulatory Issues for Medical Devices," Utah Life Science Association (2/18/2005)

· "Update on State, Local and Grass Roots Challenges to FDA Enforcement and Industry Measures Against Importation/Reimportation," American Conference Institute, Legal and Business Forum on Drug Importation and Reimportation, Washington, DC (11/8/2004)

· "Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington Report (12/8/2003)

· "Hatch-Waxman Act and Recent Developments," Regulatory Affairs Professionals Society (RAPS) Annual Conference (10/20/2003)

· "Consent Decrees, Disgorgement of Profits, and FDA's Recent Enforcement Surge," Food and Drug Law Institute's Third Annual Enforcement and Litigation Conference, Washington, DC (September 2003)

Judicial Clerkship

· Hon. David M. Ebel, U.S. Court of Appeals, Tenth Circuit, 1994-1995