Caitlyn J. Ozier

Counsel
Government Matters & Regulation
Bio

Caitlyn Ozier counsels pharmaceutical, biotechnology, and medical device companies on regulatory, compliance, and enforcement issues affecting sales, marketing, and pricing activities.

Caitlyn advises clients on laws regulating drug pricing decisions. She has extensive experience with key provisions of the Inflation Reduction Act, particularly the Medicare Drug Price Negotiation Program, from initial drug selection through negotiation and maximum fair price effectuation. She also regularly counsels clients on state drug price transparency and prescription drug affordability board laws.

Caitlyn also focuses on federal and state initiatives promoting transparency in financial relationships between manufacturers and health care providers, as well as laws and industry standards governing interactions with health care providers. These include the federal Physician Payments Sunshine Act, gift bans, compliance program mandates, the PhRMA and AdvaMed Codes, sales representative licensing and registration requirements, government ethics laws, and lobbying laws. She also counsels the Ad Hoc State Law Compliance Group, a coalition of pharmaceutical, biotechnology, and medical device manufacturers, on these laws.

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Capabilities
FDA & Life Sciences
Capabilities
Life Sciences & Healthcare
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