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People
Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 18 years' experience. Nikki co-chairs the firm’s Life Sciences and Healthcare Industry Group, which is comprised of more than 300 lawyers across the firm. A partner in 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 to good manufacturing practices to labeling, advertising, and promotion of FDA-regulated products. Nikki has been the lead FDA regulatory advisor to her clients on 100+ transactional matters. She is an expert on federal Sunshine, state, and international transparency/disclosure laws and leads two industry compliance coalitions.
Nikki counsels pharma and device companies on FDA 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 noncompliance and presents findings to company executives and board members. She handles company responses to government inquiries and related communications to the government for her clients. 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.
Nikki is a frequent speaker and author on FDA advertising/promotion and transparency law matters. She currently serves on the Advisory Board for FDAnews. 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.
Nikki was elected by her partners to serve a three-year term on the firm’s Policy Committee in 2017. Nikki previously served a three-year term as a member of the firm’s Lateral Partner Committee and a three-year term as a member of the firm's Partners Committee, and served a two-year term as the Hiring Partner for the Washington, D.C. office.
Credentials
J.D., University of Maryland, high honors, Order of the Coif
M.P.A., North Carolina State University, cum laude
B.A., North Carolina State University
District of Columbia
Maryland
Matters
Advised companies on advertising and promotion activities for drugs, devices, and cosmetics, including new product launches, physician and DTC/DTP advertising, social media, broadcast ads, reprint dissemination, and investor communications.
Advised on compliance with the federal Physician Payment Sunshine 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.
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Matters
Advised companies on advertising and promotion activities for drugs, devices, and cosmetics, including new product launches, physician and DTC/DTP advertising, social media, broadcast ads, reprint dissemination, and investor communications.
Advised on compliance with the federal Physician Payment Sunshine 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 100+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.
Set 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.
Insights
Client Alert
October 9, 2018
Cleanup on Title 5: Executive Agencies and Courts Begin to Unpack Lucia, as Litigants Eye Challenges to the Administrative State
Article · Source: American Bar Association Business Law Today
September 26, 2018
Cleanup on Title 5: Executive Agencies and Courts Begin to Unpack Lucia, as Litigants Eye Challenges to the Administrative State
Client Alert
June 21, 2018
FDA Finalizes Guidances for “Consistent Communications” and Payor Communications
Matters
Advised companies on advertising and promotion activities for drugs, devices, and cosmetics, including new product launches, physician and DTC/DTP advertising, social media, broadcast ads, reprint dissemination, and investor communications.
Advised on compliance with the federal Physician Payment Sunshine 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.
See more
Close
Matters
Advised companies on advertising and promotion activities for drugs, devices, and cosmetics, including new product launches, physician and DTC/DTP advertising, social media, broadcast ads, reprint dissemination, and investor communications.
Advised on compliance with the federal Physician Payment Sunshine 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 100+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.
Set 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.
Insights
Client Alert
October 9, 2018
Cleanup on Title 5: Executive Agencies and Courts Begin to Unpack Lucia, as Litigants Eye Challenges to the Administrative State
Article · Source: American Bar Association Business Law Today
September 26, 2018
Cleanup on Title 5: Executive Agencies and Courts Begin to Unpack Lucia, as Litigants Eye Challenges to the Administrative State
Client Alert
June 21, 2018
FDA Finalizes Guidances for “Consistent Communications” and Payor Communications
Credentials
J.D., University of Maryland, high honors, Order of the Coif
M.P.A., North Carolina State University, cum laude
B.A., North Carolina State University
District of Columbia
Maryland