Audrey Mercer is an associate who specializes in the life sciences and healthcare industries and works out of the firm's Dallas office.
Audrey represents clients in the life sciences and healthcare industries by advising on regulatory compliance matters under federal and state law, with a primary focus on FDA legal, regulatory, and compliance matters. Audrey regularly counsels clients in the pharmaceutical and medical device industries on a wide range of regulatory and compliance matters relating to the development, manufacture, and marketing of FDA-regulated products – including, but not limited to: (i) product development through various FDA pathways, such as New Drug Applications, Accelerated Approval Applications, 510(k) Clearances, De Novo Classifications, and Premarket Approval Applications; (ii) labeling, advertising, and promotional review; (iii) drug price transparency reporting and related confidentiality issues; (iv) internal and external compliance investigations; (v) transparency reporting, (vi) product-related contracts, including, but not limited to, Clinical Trial Agreements, Quality Agreements, and Product Donation Agreements, (vii) due diligence for related corporate transactions; and (viii) compliance with other FDA post-market requirements, such as current good manufacturing practices (cGMP) and Quality System Regulation (QSR).
Additionally, Audrey has experience counseling clients on broader regulatory issues, such as healthcare facility licensing, state and federal fraud and abuse limitations, Medicare/Medicaid participation requirements, and conducting due diligence in transactional matters, among other regulatory topics.
Audrey is also a contributing member of Sheppard's Pro Bono Committee and regularly assists pro bono clients in completing United States Customs and Immigration Services applications.
Audrey earned her J.D. from Southern Methodist University Dedman School of Law in Dallas, Texas, where she graduated with honors. She was the recipient of the Don Smart Directed Research Award for her article titled, "A Renewed Emphasis on Charity Care: Incentivizing Nonprofit Hospitals to Address the Nation's Indigent Care Needs." Since joining the firm, Audrey has also been published in the New York Law Journal, Bloomberg Law, and Law360 for publications such as "Industry Fights Back Against Restrictions on Pharmaceutical Manufacturers' Ability To Offer Drug Cost-Sharing Subsidies," "New FDA Rules Can Weed Out Drugs Masquerading as Cosmetics," and "Rare FDA Move Shows Stance On Remote Monitoring Devices."