Audrey Crowell

Audrey Crowell is an associate in the Governmental Practice in the firm's Dallas office and a member of the Healthcare and Life Sciences teams.

Areas of Practice

Audrey represents clients in the healthcare and life sciences industries by advising on regulatory compliance matters under federal and state law. Audrey has counseled numerous clients on pre- and post-market requirements for both drugs and devices, healthcare facility licensing, fraud and abuse limitations, and Medicare/Medicaid participation requirements, among other regulatory topics. Audrey also represents clients in business and transactional matters, including mergers & acquisitions and corporate governance.

Audrey earned her J.D. form 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.” Additionally, Audrey served as an editor for the SMU International Law Review, with a focus on global healthcare disparities.

Honors

Healthcare Influencer, GlobeSt’s Real Estate Forum, 2022

Articles

Healthcare Law Blog Posts

• "The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants," June 21, 2023
• "Payor-Led Initiatives to Strengthen Mental Health Resources," March 20, 2023
• "CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs," February 22, 2023

• "Proposed Rule Leverages Section 1557 for Healthcare Equity," August 22, 2022
• "Supreme Court Discrimination Case Narrows Scope of Restitution for Individuals," May 25, 2022
• "Tax Break for Certain Medical Billing Services in Texas," March 1, 2022
• "Debate Continues Around Scope of Practice Expansion for APPs," December 13, 2021

FDA Law Blog Posts

• "FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices," July 26, 2023

• "FDA Clarifies Approach to Pediatric Drug Development," June 5, 2023

• "Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway," April 26, 2023

• "FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices," April 10, 2023

• "FDA Expands Inspection Guidance to Apply to Device Manufacturers," December 27, 2022

• "FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization," November 30, 2022
• "OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies," October 13, 2022

• "FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products," August 8, 2022

• "FDA Issues Final Guidance on Drug and Biological Instructions for Use (IFU)," July 21, 2022

Events