Nikki Reeves

• Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.
• Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.
• Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.
• Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.
• Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.
• Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.
• Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.

Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25 years of experience. Nikki co-chairs the firm's Government Matters & Regulation practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas. Nikki previously co-chaired the firm’s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450 lawyers across seventeen practice areas in the firm. In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence & Power in Law Award for Law Firm Thought Leadership. Nikki is ranked nationally by Chambers USA for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a Law360 Compliance MVP in 2020. 

As Deputy Chair of our FDA & Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products. Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters. She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.  She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions. 

Nikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.  She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance. She routinely advises company executives and board members and represents her clients before federal agencies. She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.

Nikki leads two pharma and device industry coalitions on transparency and disclosure laws. The Ad Hoc Sunshine and State Law Compliance Group is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws. The International Marketing and Disclosure Compliance Group is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.

King & Spalding’s FDA & Life Sciences Practice has been named Law360 Practice Group of the Year from 2017-2020. King & Spalding’s FDA & Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers. According to Chambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA (2022)

Nikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters. Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board and has served on the Advisory Board for FDAnews and the PCF Pharma Congress planning committee. She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the FDLI Food & Drug Law Journal and a member of the FDLI Medical Device Committee. Nikki has also served on the Leadership Advisory Board for the National Women’s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten years.

Nikki was elected by her partners in 2017 to serve for three years on the firm’s Policy Committee, which is the firm's executive management committee. Nikki served for many years on the firm’s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.