DELIA A. DESCHAINE is a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office. Named to the Washington DC Rising Stars list (2018-2020) in the areas of Food & Drugs and Cannabis Law, Ms. Deschaine understands the most significant U.S. Food and Drug Administration (FDA) and U.S. Drug Enforcement Administration (DEA) legal and compliance risks that her clients face and knows how to address them. Her advice is informed by a background in defending clients in government enforcement actions and challenging unlawful government conduct.
Ms. Deschaine’s experience includes:
- Counseling pharmaceutical and biotechnology companies, such as manufacturers, wholesalers, pharmacies, researchers, and others on their regulatory obligations under the federal Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA), including compliance with current Good Manufacturing Practices (cGMP) and the DEA's expectations related to suspicious order monitoring, registration, recordkeeping, security, and reporting
- Advising clients on the federal and state regulation of cannabis, including hemp and hemp-derived products
- Counseling clients on the federal and state regulation of controlled substances, with a focus on the manufacture, distribution, and dispensing of opioids, and assisting clients in controlled substance scheduling-related matters
- Helping clients respond to problematic FDA inspections, including responding to Form FDA 483s and Warning Letters
- Assisting clients in developing, implementing, and managing corrective action plans
- Counseling on the requirements of cGMP as they apply to aseptic processing, quality risk management, supplier management, and data integrity, and conducting cGMP compliance audits
- Advising clients on compliance with state pharmacy laws, including licensing requirements
- Conducting internal investigations, and defending clients in administrative, civil, and criminal investigations under the CSA, the Combat Methamphetamine Epidemic Act (CMEA), and the FDCA
- Performing regulatory due diligence, and reviewing and revising agreements in corporate transactions
Before joining Epstein Becker Green, Ms. Deschaine was a pharmaceutical and biotechnology regulatory lawyer at an international law firm. Previously, she was an attorney at a prominent boutique FDA regulatory law firm in Washington, DC, where she represented pharmaceutical, medical device, and biotechnology companies in FDA and DEA enforcement actions and litigation. Earlier in her career, through the U.S. Attorney General’s Honors Program, she served as an Attorney Advisor for the DEA, where she received a Performance Award in 2011.
In law school, Ms. Deschaine served as a lawyer advocate for a public interest organization, focusing on remedying the legal and systemic barriers that prevent access to addiction treatment services. She was also a legal intern for Magistrate Judge Susan K. Gauvey of the U.S. District Court for the District of Maryland.