Michelle L. Butler
Michelle L. Butler provides counsel on government pricing, health care, and FDA law in the area of prescription drugs and biologics. Across these practice areas, she specializes in the interpretation of complex regulations. Ms. Butler advises clients on changes in health care law and how these changes affect calculation and reporting across government pricing programs, specifically the Medicaid Drug Rebate Program, the 340B Program, the Medicare Part B Average Sales Price calculation, and the Veterans Health Care Act's federal ceiling price restrictions. In the area of fraud and abuse, Ms. Butler provides counsel on structuring financial and incentive arrangements among manufacturers, health care providers, pharmacies, and patients.
Since joining the firm in 1998, Ms. Butler has worked on a range of regulatory and enforcement matters, including corporate transactions, prescription drug matters, and civil litigation, including Average Wholesale Price (AWP) cases. Within the area of prescription drugs and biologics, she focuses on Hatch-Waxman, orphan drug matters, and user fee issues. In particular, Ms. Butler advises clients on key issues related to PDUFA waivers, with a focus on those for small businesses. She provides counsel on biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), which is the biological counterpart to Hatch-Waxman and an evolving part of the Patient Protection and Affordable Care Act (PPACA). Ms. Butler also assists clients with corporate transactions, including work related to financings, mergers, and acquisitions involving pharmaceutical and biotechnology companies. She routinely conducts FDA-related diligence and provides practical advice to assist clients with making acquisition or valuation determinations.
Government Pricing and Contracts
• Counsels clients on the Medicaid Drug Rebate Program, the 340B Program, the Medicare Part B Average Sales Price calculation, and other government pricing and reporting programs, including the implementation of provisions of PPACA.
• Advises clients on the Veterans Health Care Act federal ceiling price restrictions, calculation of Non-FAMP, negotiation of FSS contracts, and small business subcontracting plans.
• Helps clients develop policies and procedures for government pricing programs.
• Conducts due diligence reviews for companies engaged in mergers, acquisitions, and other corporate matters.
• Acts as lead FDA counsel representing issuers or underwriters for IPOs and follow-on offerings.
Prescription Drugs and Biologics
• Advises clients on Hatch-Waxman issues, 505(b)(2) applications, and biosimilars BPCIA.
• Helps clients obtain orphan drug designations as part of a broader product strategy.
• Provides counsel on PDUFA waivers, particularly small business waivers, and combination products.
Articles / Publications
see more articles
• HPM/KPMG Webinar: A Practical Guide to the MDRP Final Rule,
February 19, 2016
• Summary of MDRP Final Rule,
February 01, 2016
• Summary of HRSA 340B Proposed Guidance,
September 3, 2015
• PhRMA Releases Revised "Code on Interactions with Healthcare Professionals" More Restrictive than July 2002 Version; HPM Issues Summary Memorandum,
July 10, 2008
• CMS Final Rule on the Drug Rebate Program,
August 9, 2007
see more speaking engagements
• Webinar: 21st Century Cures Act - Pharmaceutical and Biologic Product Development Provisions, January 12, 2017
• Medicaid Rebate Final Rule Published in Federal Register; HP&M Issues Summary, Schedules Webinar, February19, 2016
• Webinar - A Practical Guide to the Medicaid Drug Rebate Program Final Rule, February 19, 2016
• 2015 FDA-OCRA Annual Educational Conference, Reg Affairs Discussion, New Regulatory Updates for All Regions, June 3-4, 2015
• ACI: RX Drug Pricing Boot Camp, Federal Government Contracts and Pricing: FSS, VA, DOD and More, May 26, 2010
see more blog entries
• 21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary Webinars,
January 5, 2017
• Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two),
December 15, 2016
• The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One),
December 13, 2016
• CMS Issues Release to Manufacturers Regarding Value-Based Purchasing Arrangements,
July 18, 2016
• VA Changes Course to Require Covered Drugs that are TAA Non-Compliant to be Available on the Federal Supply Schedule,
April 21, 2016