Stefanie Doebler is special counsel in the firm's health care and food and drug practice groups. Her practice focuses on health care compliance matters for pharmaceutical and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
- Advice to trade association regarding implementation of the federal Sunshine Act and related advocacy before the Centers for Medicare and Medicaid Services.
- Assistance to a pharmaceutical company regarding compliance with a corporate integrity agreement, including developing and implementing a comprehensive compliance program.
- Advice on kickback and related issues associated with product support programs for a specialty pharmaceutical product.
- Evaluation of the promotional activities of a medical device company to identify high-risk initiatives.
- Representation of major pharmaceutical company in criminal investigation under the FDCA.
- Internal investigation for a pharmaceutical company regarding its publications policies and practices.
- Representation of a local non-profit organization in legislative and regulatory efforts to ensure that the regional affiliate of a national insurance company fulfills its charitable health care obligation to the National Capital Area.
- Assistance to dual-eligible individuals regarding their Medicare prescription drug benefits
Publications and Speeches