Michelle L. Butler

For more than 25 years, Michelle Butler has counseled pharmaceutical and biotechnology companies on FDA law, drug development, and government pricing. She advises clients on developing regulatory strategies for prescription drugs and biologics from early development through commercialization. Across these practice areas, she is recognized for her ability to translate complex statutory and regulatory requirements into practical, business-oriented solutions.

Ms. Butler counsels clients on regulatory strategy for the development of new drugs and biologics, guiding sponsors from pre-IND planning and IND submission through clinical development, marketing application review, and FDA approval. She advises on a broad range of FDA regulatory issues affecting product development, including clinical trial strategy, regulatory pathways, interactions with FDA, and compliance with applicable regulatory requirements. She also represents clients in formal dispute resolution proceedings involving agency actions such as complete response letters, clinical holds, and other significant regulatory decisions. In addition, Ms. Butler advises on user fee matters, with particular experience in obtaining PDUFA waivers and exemptions.

Ms. Butler also serves as regulatory counsel on strategic corporate transactions, including venture financings, public offerings, mergers and acquisitions, and licensing and collaboration agreements. She routinely conducts FDA regulatory due diligence, reviews transaction disclosures and agreements, assesses regulatory risks, and provides practical guidance that supports valuation, investment, and acquisition decisions.

In addition, Ms. Butler advises clients on compliance with federal government pricing and market access requirements. She counsels manufacturers on calculation and reporting obligations under the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, the Medicare Part B Average Sales Price program, and the Veterans Health Care Act’s Federal Ceiling Price requirements. She also advises clients on the implementation of legislative and regulatory changes affecting these programs.