Kelly N Reeves (Nikki)

Nikki Reeves is a partner in King & Spalding’s FDA & Life Sciences Practice Group in Washington, D.C.  She counsels pharmaceutical, biotechnology, and medical device companies on a broad range of FDA and healthcare regulatory compliance matters, including clinical trial regulation, product advertising/promotion, quality system regulation/good manufacturing practices, FDA enforcement actions, and federal healthcare compliance programs.  Ms. Reeves is an expert on state aggregate spend disclosure laws targeting the pharmaceutical and device industries and the federal Physician Payment Sunshine provisions recently enacted as part of healthcare reform.  She is lead counsel to the Ad Hoc State Law Compliance Group, a coalition of pharmaceutical and device manufacturers that she advises on these state and federal laws.  Ms. Reeves has also advised clients in the food and cosmetic industries. 

Ms. Reeves is a frequent speaker for the Pharmaceutical Compliance Forum and the Food and Drug Law Institute.  She serves on the FDLI Food and Drug Law Journal Editorial Advisory Board.  She has published several articles on FDA regulation of medical device and prescription drug advertising/promotion and new state laws regulating drug and device industry marketing practices. 

Recent Publications

Speeches

• “Here Comes the (Sun)shine: Understand State and Sunshine Regulations to Meet Aggregate Spend Requirements,” CBI’s 7th Annual Medical Device and Diagnostics Compliance Congress, Tyson’s Corner, VA (June 7, 2011)
  
  
• “2010 DDMAC Letters: Emerging Trends and Lessons Learned,” ACI Advertising, eMarketing & Promotions for the Pharmaceutical Industry, Philadelphia, PA (March 16, 2011)
  
  
• “Navigating Unclear and Conflicting State Laws and Regulations,” ACI Physician Payments Disclosure and Aggregate Spend Conference, New York, NY (October 26, 2010)
  
  
• “Federal Sunshine Act and State Disclosure Laws: Top Challenges and Compliance Best Practices,” Tenth Annual Pharmaceutical and Regulatory Compliance Congress, Washington, D.C. (October 21, 2010)
  
  
• “Federal Physician Payment Sunshine Provisions,”  Pharmaceutical Compliance Forum Fall Meeting, Philadelphia, PA (September 22, 2010)
  
  
• “Sunshine, State Laws, and Aggregate Spend Bootcamp -- A 101 Course,” CBI’s 4th Annual Forum on Tracking State Laws and Aggregate Spend, Washington, D.C. (August 16, 2010)
  
  
•  “Advanced Issues in Clinical Compliance,” Tenth Annual Pharmaceutical and Regulatory Compliance Congress, Washington, D.C. (November 11, 2009)
  
  
• “New Trends in Clinical Research: Increased Oversight and Transparency,” Fourth National FDA Symposium, Washington, D.C. (September 30, 2009)
  
  
• “State Law and Sunshine Act Update,” Pharmaceutical Compliance Forum Annual Meeting, Bridgewater, NJ (September 15, 2009)
  
  
• “Oversight and Transparency in Clinical Research,” (Keynote Speaker) CBI’s Clinical Research Studies Conference - Clinical Compliance for Clinical Operations, Philadelphia, PA (July 14, 2009)
  
  
•  “Recognizing and Reducing Risks Associated with the Dissemination of Clinical Trial Information,” ACI 5th Annual Pharmaceutical and Medical Device Manufacturer’s Guide to Off-Label Communications,  Philadelphia, PA (July 17, 2008)
  
  
•  “How to Conduct a Clinical Research Compliance Assessment,” Eighth Annual Pharmaceutical and Regulatory Congress, Washington, D.C. (November 7, 2007)
  
  
•  “Clinical Research Program Compliance Challenges,” PILLS seminar, San Francisco (September 6, 2007)
  
  
•  “State Laws Targeting Life Sciences Companies,” Life Sciences Law Institute, American Health Lawyers Association, San Francisco (April 25, 2007)
  
  
•  “Medical Device Advertising Promotion” panel, FDLI Advertising and Promotion Conference, Bethesda, MD (September 19, 2006)
  
  
•  “Post-Approval Issues for Marketed Drugs” and “FDA Regulation of Over-the-Counter Drug Products,” Introduction to Drug Law course, Food and Drug Law Institute, Washington, D.C.  (June 27, 2006)
  
  
•  “In the Bull’s Eye: State Laws Target Drug Marketing, Drug Pricing, and Clinical Trials,”Life Sciences Law Institute, American Health Lawyers Association, Baltimore, Maryland (May 2, 2006)
  
  
•  “Legal Perspectives on 505(b)(2) Applications,” Drug Information Association 41st  Annual Meeting, Washington, D.C.  (June 27, 2005)

Articles

• “State Marketing Laws Impacting Medical Device Manufacturers,” Andrews Medical Devices Litigation Reporter, February 1, 2010 (co-author)
  
  
• “FDA Publishes Draft Guidance for Industry on Presenting Risk Information During Prescription Drug and Medical Device Promotion,”  The Metropolitan Corporate Counsel, July 2009 (co-author)
  
  
• “How The New Massachusetts Marketing Code Of Conduct And Disclosure Requirements Will Impact Medical Device Manufacturers,” American Health Lawyers Association, 7 Health Lawyers Weekly 14, Apr. 10, 2009 (co-author)
  
  
• Chapter on “State Regulation of Life Sciences Companies” in The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech published by the American Health Lawyers Association (April 2007)
  
  
•  “New Sheriffs on the Block:  Growing Number of State Laws Target Drug Marketing and Promotion,” FDLI UPDATE magazine (May/June 2005 issue)
  
  
•  “Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or Manipulating a Vulnerable Population?,” 53 Food & Drug L.J. 661 (1998) (won the Food and Drug Law Institute’s H. Thomas Austern Memorial Writing Competition award) (cited by the New Jersey Supreme Court in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999))