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Datta, Meenakshi

Meenakshi Datta

Partner
Healthcare
Crisis Management and Strategic Response
Privacy and Cybersecurity

Biography

MEENA DATTA is a member of the firm’s Executive Committee and global co-leader of Sidley’s Healthcare practice. She also serves as a leader in the firm's Global Life Sciences Leadership Council and leads the Chicago Healthcare group and the firm’s Digital Health Initiative. She was recognized as Regulatory Attorney of the Year: Pricing and Reimbursement in LMG Life Sciences 2021 edition, a marquee award for life sciences lawyers. In 2023, Meena was designated as an “Emerging Therapies/Life Sciences Trailblazer” in The National Law Journal, a designation awarded to lawyers assisting the most novel life sciences companies with their most challenging legal issues. Meena manages key strategic regulatory, transactional, litigation, and enforcement matters for life sciences, healthcare, and health technology companies throughout the world. Clients have said the following about Meena:

“Meena is very important to us. She's an excellent problem-solver and capable of being a strong academic who demonstrates extraordinarily strong, big picture work.”
Chambers USA 2025
"Meena is the best of the best. Her experience, knowledge and client-focused service are second to none."
Chambers USA 2025

Offers a Broad Perspective. Meena is highly experienced in representing both Fortune 100 healthcare and life sciences companies as well as small biotech, medtech, and telehealth companies, and regularly advises Boards of Directors and c-suite personnel on sensitive regulatory matters. Her client base includes pharmaceutical and medical device manufacturers and their trade associations and private foundations; manufacturer not-for-profit coalitions; distributors; large healthcare providers; telemedicine and telehealth providers; genetic and early cancer detection screening companies; clinical diagnostic laboratories; private equity firms and public companies focused on healthcare and life sciences investments; health tech companies; and innovators and disruptors.

Litigation and Enforcement Proceedings. Meena aggressively defends clients on healthcare regulatory theories of liability – particularly drug pricing and Anti-Kickback Statute theories – in the context of enforcement initiated by the Department of Justice and Office of Inspector General, Department of Health, and Human Services. She also regularly leads Sidley teams that mount litigation challenges and pursue advocacy strategies in response to controversial regulatory developments, particularly drug pricing and reimbursement issues, including most recently the challenge to the most favored nations reference pricing regulation: Cal. Life Scis. Ass'n v. Ctr. for Medicare & Medicaid Servs., No. 20-CV-08603-VC, 2020 WL 7696050, at *2 (N.D. Cal. Dec. 28, 2020).

Leads Drug Price Reporting Matters. Meena is regarded as a leading government price reporting practitioner in the country. Her experience spans the Inflation Reduction Act, Medicaid Drug Rebate Program, Average Sales Price, the 340B Drug Pricing Program, and non-FAMP and the Federal Ceiling Price. She advises dozens of clients on drug price reporting compliance matters including bona fide service fees, wholesaler fees, line extensions, smoothing, transfer price, and authorized generics issues, and impact of patient access and assistance programs on government pricing. She is frequently sought by clients for review of and updates to internal methodology policies, and she brings a wealth of benchmarking and best practices to her counseling. She has won declinations from DOJ on drug pricing enforcement issues, and has successfully led major disclosures and restatements to the government agencies including CMS, HRSA, and VA. She has cultivated and trained a deep bench of experienced lawyers who support this work and operate efficiently from a time and cost perspective on client projects of all sizes. Meena also leads the firm’s Global Drug Pricing Task Force.

Solves Complex Regulatory Problems. Meena helps clients solve critical business problems and formulate litigation strategy involving drug pricing; healthcare reform; fraud and abuse compliance, particularly in the design and execution of arrangements in compliance with the Federal Anti-Kickback Statute and the Travel Act; the Eliminating Kickbacks in Recovery Act (EKRA); state drug price transparency laws; federal healthcare program coverage and reimbursement issues; healthcare compliance programs; market access; HIPAA and HITECH implementation and compliance; and the Sunshine Act and similar state laws. 

Counsels on Market Access and Drug and Device Product Launches. Over the years, Meena has served as lead healthcare counsel in 50 new drug and device product launches, where she has effectively partnered with in-house counsel and business teams on a wide variety of critical business issues including clinical trial design; distribution and market access models; value-based arrangements; patient assistance programs; early access and post-trial access programs; drug pricing; and customer interactions in the field. A substantial portion of her work in this area is for novel drug therapy companies focused on rare diseases, gene therapy, cell therapy, and digital therapeutics. She has earned the reputation of being practical and clients appreciate her cost-effective staffing model depending on the nature and complexity of the market access work.

Compliance Investigations, Program Design, and Execution. Meena is one of the leading healthcare compliance program lawyers in the country. She also adds a significant breadth of knowledge across various settings of care in order to help her clients conduct internal investigations and risk assessments where the key considerations are of a regulatory nature and has helped dozens of clients establish effective compliance programs and compliant patient assistance programs. Her clients find her pragmatic and solution-oriented.

Quarterbacks Global Regulatory and Compliance Due Diligences and Reviews. Meena also regularly leads regulatory due diligences for private equity and M&A transactions, compliance program assessments, as well as sensitive internal reviews on a global and programmatic scale, making key recommendations on diligence strategy and areas of potential risk. She is recognized by clients for providing pragmatic and actionable remediation advice.

“[Meena]'s our go-to for high stake, critically important business issues. She's sharp, responsive, and creative. We rely on her intelligent, practical advice daily.”
Chambers USA 2025

Nationally Recognized. Chambers USA has ranked Meena in the areas of USA — Nationwide Life Sciences: Regulatory/Compliance (2023–2025), Illinois Healthcare (2015–2017; 2020–2025), and Illinois Healthcare: Pharmaceutical/Medical Products Regulatory (2022–2025). Chambers Global has ranked her for Nationwide Life Sciences: Regulatory/Compliance (2025). Chambers USA described her in 2020 as having “impressive…regulatory expertise, and is frequently sought after to handle Medicaid reimbursement and price reporting matters” and was described by her clients as “an absolute expert in healthcare.” Underscoring the depth of Sidley's talent, Meena's team was identified in LMG Life Sciences' 2023 and 2022 editions as first tier for Healthcare: Pricing & Reimbursement, and she was individually ranked as a “Life Sciences Star” in the FDA: Medical Device, FDA: Pharmaceutical, and Healthcare Pricing & Reimbursement categories (2020–2024). Meena was also shortlisted as the Women in Business Law Americas 2024 “Life Sciences Lawyer of the Year.” She also was designated in The National Law Journal as a 2020 “Health Care/Life Sciences Trailblazer” and a 2023 “Emerging Therapies/Life Sciences Trailblazer,” each an annual special supplement that spotlights individuals working on a range of life sciences and health care issues, dubbing them “agents of change.” In 2022, Crain’s recognized Meena in its rankings for Chicago Business “Notable Women in Law,” making this the second time she has received this distinction. She was recognized in the 2013 and 2016 editions of Legal 500 United States, which reported in its 2013 edition that Meena is a “pricing and fraud and abuse specialist.” Additionally, Best Lawyers in America® has ranked Meena for Health Care Law (2026). 

Meena received her B.A. from Brown University and her J.D. from the University of Chicago Law School. Meena is regularly quoted by nationally recognized healthcare trade press and is a frequent speaker at key life sciences conferences. Meena has lectured for a Healthcare Management course at Loyola University’s Chicago Graduate School of Business and the Seton Hall Law School Healthcare Compliance Certificate Program. Meena is a proud member of the Board of Directors of the March of Dimes, Chicago Chapter.

Experience

Representative Matters

  • Representing affiliates of WCAS and Managed Market Insights & Technology in connection with MMIT's US$1.6 billion merger with Evaluate.
  • Regulatory diligence for Stonepeak in its debt and equity financing to Akumin in connection with Akumin’s acquisition of Alliance Healthcare Services. Stonepeak’s financing commitment is for US$700 million to be used to fund the acquisition and, to the extent unused for the acquisition, under certain circumstances, may be used to fund future growth equity. The acquisition transaction has an enterprise value of US$820 million.
  • Regulatory diligence for LifePoint Health in its acquisition of Kindred Healthcare. The combination of LifePoint Health and Kindred Healthcare will create a leading diversified healthcare delivery network with expanded services, resources, and expertise to grow and invest in community healthcare while advancing LifePoint’s mission of making communities healthier.
  • Regulatory advice for Fortive Corp. in its US$2.7 billion acquisition of Johnson & Johnson subsidiary Ethicon’s advanced sterilization products (ASP) business.

Credentials

Admissions & Certifications
  • U.S. District Court, N.D. of Illinois - General
  • Illinois
Education
  • The University of Chicago Law School, J.D., 2003
  • Brown University, B.A., 2000

Related Blogs

News & Insights

  • Speaker, “#DrugPricing: Average Sales Price (ASP) Calculation in Focus,” Sidley Austin LLP, November 20, 2025.
  • Speaker, “Mini Summit 32: Government Pricing: Finding Compliance Zen,” Twenty-Sixth Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, October 2025.
  • Speaker, “Pre-Conference Transatlantic Regulatory Briefing — Transatlantic Regulatory Insight: Opportunities for Strategic Life Sciences Investment in the U.S., UK, and EU,” Sidley Healthcare Investment Conference, September 2025.
  • Speaker, “Enforcement Panel — Explore Emerging Trends and Current High-Risk Areas,” PCC West, September 2025.
  • Speaker, “Most Favored for All (or Just for Some)? MFN and the Future of Pharma Pricing,” HBM Biopharma Summit, September 2025.
  • Speaker, “Fireside Chat: External Counsel Roundtable Part I,” Medicaid Drug Rebate Program Summit, September 2025.
  • Speaker, “What’s New in Fair Market Value?,” Medicaid Drug Rebate Program Summit, September 2025.
  • Speaker, “New Product Development Pathways for Success,” Sidley Austin LLP 5th Annual Boston Life Sciences Roundtable, Navigating New Frontiers, May 2025.
  • Speaker, “Breaking Down Silos in Pricing & Contracting, Life Sciences Pricing & Contracting USA,” Cross-Functional Excellence, May 2025.
  • Speaker, “Law Firm Benchmarking Session — Chairs of Life Science Groups in Law Firms,” Pharmaceutical Compliance Congress, April 2025.
  • Speaker, “Pharmaceutical Compliance: Emerging Trends & Best Practices for 2025,” Pharmaceutical Compliance Congress, Complimentary Webcast, March 2025.
  • Speaker, “Ask the Attorneys — What Keeps You Up at Night?,” Medicaid Drug Rebate Program Summit, Chicago, IL, September 2024.
  • Speaker, “What’s New in Fair Market Value?” Life Sciences Pricing & Contracting USA, May 2024.
  • Moderator, “Fireside Chat: External Counsel Roundtable,” Life Sciences Pricing & Contracting USA, May 2024.
  • Speaker, “Industry Guidance for Emerging Trends and Best Practices for the Year Ahead,” Pharma and MedTech Compliance Webinar, April, 2024.
  • Speaker, “Enforcement Panel—Focal Points and Priorities for 2024 and Beyond,” PAP Patient Assistance & Access Programs, March 2024.
  • Speaker, “State of the Industry Panel: The State of National Healthcare Policy and Pricing Webinar,” Informa Connect Webinar, January 2024.
  • Speaker, “IRA Panel Discussion,” KoreaBIO, JPM 2024, January 2024.
  • Speaker, “Editorial Panel: Exploring the Inflation Reduction Act: Pharma’s Legal Battles and the Future of Innovation,” Fierce JPM 2024, January 2024.
  • Speaker, “Policy Outlook: Assessing the Impact of the Inflation Reduction Act,” BIO Investor Forum, October 2023.
  • Moderator, “Reassessing the Relationship Between Medical and Commercial Teams,” Compliance Congress for Specialty Products, September 2023.
  • Speaker, “Fireside Chat: External Counsel Roundtable,” Medicaid Drug Rebate Program Summit, September 2023.
  • Moderator, “Panel: Government Pricing and The Seven Elements of an Effective Compliance Program,” Medicaid Drug Rebate Program Summit, September 2023.
  • Moderator, “Sidley Digital Health East” at MassBIO, May 2023.
  • Speaker, “Inflation Reduction Act,” Boston Life Sciences Roundtable at MassBIO, May 2023.
  • Speaker, “Fireside Chat: External Counsel Roundtable,” Informa Connect Medicaid Conference, May 2023.
  • Moderator, “Enforcement Panel — Understand DOJ Priorities for 2023” and “Beyond, Hub and Specialty Pharmacy Models East,” March 2023.
  • Moderator, “Explore Evolving Regulatory Reform in the Patient Support Services” and “Hub Models Space, Hub and Specialty Pharmacy Models East,” March 2023.
  • Speaker, “Policy Outlook: Understanding the Effects of the U.S. Inflation Reduction Act,” 2023 BIO CEO and Investor Conference, February 2023.
  • Speaker, “Enforcement Update – Explore Rising Oversight and High Priority Risk Areas for Patient Services Compliance,” CBI Patient Support Services Congress, November 2022.
  • Speaker, “Mini Summit 22: Navigating Telehealth Compliance Considerations for Pharma Companies,” Twenty-Third Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, October 2022.
  • Speaker, “Luncheon Table Topic Discussion: Key HCP Agreements for Biotechs: Practical Compliance Approaches,” Twenty-Third Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, October 2022.
  • Speaker, “Prepare to Negotiate: A Manufacturers Guide to New Medicare Drug Pricing Provisions under the Inflation Reduction Act,” ACI Proficiency, October 2022.
  • Speaker, “Establish Compliant Partnerships Across Medical and Commercial Teams” and “Dive into the Legal Implication and Compliance Frameworks of Patient Assistance and Copay Programs,” CBI Compliance Congress for Specialty Product, September 2022.
  • Speaker, “Fireside Chat: Drug Pricing Update, Pricing & Contracting Digital Week,” August 2022.
  • Speaker, “Regulatory Reboot: What You Need to Know About Biopharma Regulation in 2022 and Beyond,” Sidley Austin LLP, May 2022.
  • Speaker, “Fireside Chat: External Counsel Roundtable, The Washington Outlook: Where Do We Stand and What Is Likely to Happen with Current and Proposed Legislation,” Medicaid & Government Pricing Congress, May 2022.
  • Speaker, “Medicare and Medicaid Pricing Fundamentals: Key Terminology and Essential Calculations for an Evolving Payor Market,” ACI, 20th Annual Rx Drug Pricing Bootcamp, May 2022. 
  • Speaker, “Clinical and R&D Trends,” Pharmaceutical Compliance Congress, April 2022.
  • Speaker, “The State of National Healthcare Policy and Pricing,” Informa Connect Webinar, January 2022.
  • Moderator, “Mini Summit 10: What’s the Future of Drug Pricing” and “Response to OIG Special Fraud Alert and Pharma and AdvaMed Update,” Virtual 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, November 2021.
  • Speaker, “Fireside Chat,” CBI Medicaid Drug Rebate Program, October 2021.
  • Speaker, “Provider Relief Fund: What Providers Need to Know,” Sidley Austin LLP & KPMG,  August 2021.
  • Speaker, “Cell and Gene Therapies — Compliance Considerations for Highly Complex, Potentially Curative Treatments,” CBI Compliance Congress for Specialty Products, June 2021.
  • Speaker, “C-Suite Roundup! A Candid Discussion with Exceptional Business Leaders,” Sidley Austin LLP,  May 2021.
  • Speaker, “Legal and Compliance Fireside Chat,” CBI Medicaid and Government Pricing Congress, May 2021.
  • Speaker, “Optimizing Compliant Patient Interactions,” Pharmaceutical Compliance Congress, Spring Update, April 2021.
  • Speaker, “Navigate and Analyze COVID-19 and PAP Support”, CBI, PAP Critical Update Meeting, March 2021.
  • Speaker, “Explore Industry Response to OIG Special Fraud Alert on Speaker Programs”, 2021 Virtual Speaker Programs Summit, February 2021.
  • Speaker, “Update on Travel and Lodging Programs for Prescribed Medicines,” CBI 2021 PAP Conference, February 2021.
  • Speaker, “Legal and Compliance Closing Fireside Chat”, 22nd Annual Medicaid and Government Pricing Congress, December 2020. 
  • Speaker, “PBM Accumulators and GP Implications”, MDRP 2020, September 2020.
  • Speaker, “Fireside Chat — External Counsel Roundtable”, MDRP 2020, September 2020.
  • Speaker, “State Drug Pricing Transparency Legislation —What’s New and What to Do”, 6th Annual Compliance Congress for Specialty Products, September 2020.
  • Moderator, “Hub and Specialty Pharmacy Contract Oversight and Risk Assessment”, 17th Annual Pharmaceutical Compliance Congress, August 2020.
  • Speaker, “Medical Affairs Compliance”, 17th Annual Pharmaceutical Compliance Congress, August 2020.
  • Moderator, “Compliance Trends in Nurse Educator Programs”, 21st Annual Patient Assistance & Access Programs, August 2020.
  • Speaker, “Looking Ahead: Telehealth and Patient Engagement Platforms,” 5th Annual Lifesciences Roundtable, June 2020.
  • Speaker, The Hill's Virtual Roundtable, May 2020.
  • Co-Chair, ACI’s 19th Annual Forum on Rx Drug Pricing, American Conference Institute, October 2019.
  • Speaker, “Shifting Safe Harbors: Analyzing Medicare Parts B and D Pricing Reforms Under the CMS Proposed Final Rule,” ACI’s 19th Annual Forum on Rx Drug Pricing, October 2019.
  • Speaker, “Fireside Chat: External Counsel Roundtable,” Medicaid Drug Rebate Program, September 2019.
  • Speaker, “Reimbursement Part D and Market Access Update,” Medicaid Drug Rebate Program, September 2019.
  • Speaker, “Strategies for Working Across Departments Successfully,” Medicaid Drug Rebate Program, September 2019.
  • Co-Chair, 5th Annual Life Sciences Compliance Congress for Specialty Products, CBI, September 2019.
  • Speaker, “Legal and Compliance Issues for Companies Exploring Value-Based Models,” 5th Annual Life Sciences Compliance Congress for Specialty Products, CBI, September 2019.
  • Moderator, “Navigating the Political Landscape in Life Sciences: A Discussion of Politics, Policy and Consequences,” 2019 Women Leaders in Life Sciences, ACI, July 2019.
  • Speaker, “Navigate the Grey Zone of Corporate Conduct, Business Ethics and Compliance,” MedDevice MedTech Compliance Congress, CBI, June 2019.
  • Moderator, “Current Environment of State Drug Pricing Transparency,” 21st Annual Medicaid and Government Pricing Congress, CBI, May 2019.
  • Speaker, “Maintain Compliance during Patient Advocacy Initiatives,” World Congress’ 7th Annual Patient Advocacy Summit, March 2019.
  • Speaker, “Legal Risks Associated with Measuring Performance,” CBI PAP 2019, March 2019.