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Michelle Butler specializes in the areas of health care fraud and abuse, government contracts and pricing, and general food and drug law. Michelle regularly counsels pharmaceutical companies on health care compliance issues and matters pertaining to government contracts and pricing, including the Veterans Health Care Act federal ceiling price restrictions, negotiation of FSS contracts, the Medicaid Drug Rebate Program, and the 340B program. In the pharmaceutical and biologics areas, Michelle has expertise in areas including PDUFA waivers, particularly small business waivers, combination products, orphan drugs, and 505(b)(2)s. Michelle's practice also includes civil litigation, such as the AWP cases, and matters involving the Federal Trade Commission and the Consumer Product Safety Commission.
Michelle joined the firm in 1998 after graduating from the Georgetown University Law Center where she served on the staff of The Tax Lawyer. Michelle is admitted to practice law in the District of Columbia and Maryland. She received a Bachelor of Arts in Human Biology from Stanford University in 1995.
Blog Posts
CMS Proposes to Withdraw Medicaid Rebate AMP and Federal Upper Limit Regulations,
September 7, 2010
CMS Publishes Final Part D Coverage Gap Discount Agreements With Admonition to Act Quickly,
August 10, 2010
Stipulation of Dismissal in Winston Laboratories Small Business User Fee Waiver Case,
February 3, 2010
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