DEEONA GASKIN served as Associate Chief Counsel for Enforcement at the U.S. Food and Drug Administration (FDA) and is now a partner in Sidley’s Food, Drug and Medical Device group. She handles good clinical practice (GCP), current Good Manufacturing Practice (cGMP), Quality System Regulation (QSR), Mammography Quality Standards Act (MQSA), data integrity, product recalls and adverse event reporting matters on several continents, and also represents companies in False Claims Act enforcement actions and investigations.
Her representative matters include:
- Providing strategic guidance concerning marketing applications and CMC issues
- Advising clients regarding GCP and clinical holds
- Providing regulatory and compliance guidance regarding digital health and AI technologies
- Preparing clients for pre-approval and pre-licensing inspections
- Preparing pharmaceutical, medical device, gene therapy, and combination product manufacturers for regulatory inspections through on-site guidance
- Assisting clients on responses to FDA Form 483s, Warning Letters, and import alerts
- Representing clients in government investigations pursuant to the False Claims Act
- Advising clients in internal compliance investigations
- Performing data integrity assessments for clients in Asia, Europe and the United States
- Preparing recall communications for healthcare providers
- Advising clients on strategies to protect trade secrets and confidential commercial information from public disclosure under the Freedom of Information Act (FOIA) and FDA regulations
- Counseling clients on FDA regulatory issues related to corporate sales and reorganizations
Deeona has also provided training to FDA staff regarding inspections. While she was at the FDA as Associate Chief Counsel for Enforcement, she worked in conjunction with the Department of Justice (DOJ) to bring enforcement actions (including injunctions and seizures) involving drugs, medical devices, foods and dietary supplements, and personally negotiated many consent decrees. She also helped to defend the agency against lawsuits involving citizen petitions, import alerts and the Hatch-Waxman Amendments. During her time at the FDA, she received numerous awards, including the Department of Health and Human Services’ Office of the General Counsel Outstanding Newcomer Award.