Meenakshi Datta

Partner at Sidley Austin LLP

Speaker

MEENA DATTA is a member of the firm’s Executive Committee and global co-leader of Sidley’s Healthcare practice. She also leads the Chicago Healthcare group and the firm’s Digital Health Initiative, and is a member of the firm’s Global Life Sciences Leadership Council. 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. 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 (2020–2023). Meena manages key strategic regulatory, transactional, litigation, and enforcement matters for life sciences, healthcare, and health technology companies throughout the world.

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 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 30 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.

Nationally Recognized. Meena is recognized as a top healthcare lawyer in the U.S. Meena was recognized as “Regulatory Attorney of the Year: Pricing and Reimbursement,” LMG Life Sciences 2021 edition. Chambers USA has ranked her in the areas of USA – Nationwide Life Sciences: Regulatory/Compliance (2023), Illinois Healthcare (2015–2017; 2020–2023), and Illinois Healthcare: Pharmaceutical/Medical Products Regulatory (2022–2023). 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.” LMG Life Sciences also individually ranked Meena as a top regulatory lawyer in its 2020–2023 rankings. 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 The Legal 500 U.S., which reported in its 2013 edition that Meena is a “pricing and fraud and abuse specialist.” In 2016, Chambers USA praised Meena as having “a great depth of subject matter expertise which spans various health law industries.” She was named as a “Rising Star” in Law360 (2018) and the Euromoney LMG 2015 Guide.

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. She 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.