Expertise in all things FDA
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Expertise in all things FDA
Overview
For more than 25 years, Michelle Butler has provided counsel on FDA law and government pricing for companies with prescription drugs and biologics. Across these practice areas, she specializes in the interpretation of complex regulations.
Ms. Butler has worked on a range of regulatory matters, focusing on corporate transactions and counseling on prescription drugs/biologics matters. Ms. Butler’s work on corporate transactions frequently involves pharmaceutical and biotechnology companies and includes matters related to financings, including public offerings, mergers and acquisitions, and licensing transactions. She routinely conducts FDA-related diligence, reviews disclosures and agreements, and provides practical advice to assist clients with making acquisition or valuation determinations. Within the area of prescription drugs/biologics counseling, Ms. Butler’s practice includes formal dispute resolution and user fee issues, with the latter focusing on PDUFA waivers and exemptions.
Ms. Butler also advises clients on 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. Ms. Butler also advises clients on changes to those programs, as well as relevant parts of the Inflation Reduction Act, and on contracting with the federal government.