Delia Deschaine is a partner in the firm’s Global Corporate Practice, where she advises clients on the US Food and Drug Administration (FDA)’s laws, the US Drug Enforcement Administration (DEA)’s laws and US state-controlled substance and pharmacy laws.
Her practice focuses on providing comprehensive counsel to pharmaceutical, biotechnology, medical device, conventional food, dietary supplement and cosmetic manufacturers on a diverse array of issues, such as:
New product development and approval, regulatory submissions, regulatory exclusivity, formal dispute resolution, controlled substances scheduling, advisory committee review, citizen petition drafting and commentary
Compliance with the FDA’s Current Good Manufacturing Practices (CGMPs), food safety, Quality Management Systems Regulation (QMSR), reporting, recordkeeping, recalls, advertising and promotion, labeling and import and export
Delia possesses a deep understanding of the FDA’s requirements concerning CGMPs and QMSR. She routinely advises clients on their obligations in this regard, encompassing quality systems, data integrity, supply chain management, aseptic processing, hazard analysis, preventive controls, validation and sterilization protocols. Delia utilizes her expertise to assist manufacturers and suppliers in responding effectively to FDA Form 483s, warning letters and import alerts and other administrative enforcement.
Additionally, Delia concentrates her practice on the intricate federal and state regulation of controlled substances. She defends pharmaceutical and biotechnology companies, distributors, pharmacies, hospitals, physician groups, academic medical centers and researchers in controlled substances’ related government investigations and civil and administrative enforcement of the federal Controlled Substances Act (CSA). Her advisory services in this realm include:
Assisting clients in navigating controlled substances scheduling matters
Ensuring compliance with stringent DEA and state law regulatory frameworks
Conducting thorough internal investigations to address potential compliance issues and resolving disputes with the government
Delia further utilizes her subject matter expertise to deftly advise clients in corporate transactions, conduct regulatory diligence and draft and negotiate commercial agreements, including manufacturing services agreements, research agreements and quality agreements.
Delia has been named in DC Super Lawyers Rising Stars (2018-2020) and The Best Lawyers in America (2023-2024).
Represented several food manufacturers on recall related matters involving US Department of Agriculture (USDA) and FDA.
Represented a device manufacturer on a recall matter.
Represented a US infant formula manufacturer on FDA regulatory matters.
Represented a pharmaceutical company on the development of a psychedelic drug.
Represented an academic medical center in negotiating several manufacturing service agreements involving cell and gene therapy.
Represented a pharmaceutical manufacturer on matters involving the DEA and state pharmacy boards.
Represented a hospital system on matters involving the DEA and state pharmacy boards.
Represented a pharmaceutical company in an appeal of a complete response letter, leading to a favorable FDA Advisory Committee Meeting and approval of the drug.*
Drafted citizen petitions for pharmaceutical and biotechnology clients on novel issues of drug approval.*
Assisted a biotechnology client nearing launch on development of an FDA compliance program, including contract manufacturing arrangements, pharmacovigilance, drug registration and listing, National Drug Code (NDC)/labeler code requirements and state licensing matters.*
Drafted and negotiated contract manufacturing agreements, and related quality agreements, on behalf of gene therapy companies and other pharmaceutical and biotechnology clients.*
Revised supply and distribution agreements for a pharmaceutical manufacturer of controlled substances.*
Defended a client in a high-profile government investigation and litigation regarding the client’s compliance with the DEA’s suspicious-order monitoring requirements, leading to a court enjoining the DEA’s immediate suspension order and a favorable outcome of an administrative proceeding.*
Represented several manufacturers in responding to FDA Form 483s and warning letters, in every case resulting in no (or no further) enforcement action from the FDA.*
Supported a private equity company’s acquisition of a global manufacturer of cardiovascular devices, including conducting due diligence on various health regulatory matters involving FDA quality and regulatory compliance; sales and marketing practices; health regulatory corporate compliance; health information privacy and security; and state device manufacturing and distribution licensure, and assessing global health regulatory transition issues related to the transaction.*
Counseled a national telehealth company on compliance with the Ryan Haight Online Pharmacy Consumer Protection Act and related COVID-19 waivers.*
Drafted and submitted a citizen petition to the FDA on behalf of a client, raising safety concerns about a first-in-class drug and asking the FDA to take a closer look at those issues before approval.*
Represented an academic institution in negotiating various agreements related to biological research, including preclinical and clinical material transfer agreements, a clinical manufacturing services agreement and a related quality agreement.*
Represented a US pharmaceutical manufacturer in obtaining a state’s withdrawal of an opiate product registration fee request.*
Represented an academic research institution in negotiating a manufacturing services agreement and related quality agreement.*
Represented a pharmaceutical opioid manufacturer in a civil settlement regarding alleged violations of the Federal Controlled Substances Act.*
Provided legal regulatory guidance to a pharmaceutical company on the commercial launch of a new medication that is a controlled substance subject to DEA regulation.*
Conducted regulatory due diligence of a drug manufacturing business for a private equity transaction, including assessing regulatory matters falling under the FDA, the DEA, and US state-controlled substance and drug distribution laws.*
Supported a private equity sponsor in its sale of a pharmaceutical company, including aiding the company in addressing health regulatory matters involving the FDA, the DEA and state-controlled substances laws, and the Consumer Product Safety Commission.*
*Indicates work completed while at a prior firm.
Presenter, “US Marijuana Rescheduling: What It Means for Global Life Sciences R&D, Controlled Substance Compliance, and International Research Operations,” Pistoia Alliance Controlled Substances Compliance and Shipping Conference, September 30, 2026
Presenter, “Navigating Conflicting Federal and State Laws, Winning Strategies to Stay Compliant in a Fragmented Legal Landscape,” ACI, Controlled Substances Conference, January 2026
Presenter, “IND Manufacturing in the AMC Setting: cGMP, Contracting, Liability, Commercial Partnerships, COI, and Other Challenges,” American Health Law Association’s Advising Providers: Legal Strategies for AMCs, Physicians, and Hospitals Conference, February 7, 2024.
Presenter, “Appreciating the Nuances of the Approval Process for Controlled Substances,” American Conference Institute’s 41st FDA Boot Camp, September 20, 2023.
Presenter, “Introduction to Drug Law and Regulation”, Food and Drug Law Institute (FDLI), April 2023
Presenter, “Appreciating the Nuances of the Approval Process for Controlled Substances,” American Conference Institute’s 40th FDA Boot Camp, March 22, 2023.
Presenter, “CSA Compliance Think Tank: The Critical Components of an Effective Controlled Substances Compliance Program,” American Conference Institute’s 6th Annual Summit on Controlled Substances, March 13, 2023.
Co-presenter, “CSA Compliance Think Tank – Building an Effective Controlled Substances Compliance Program,” American Conference Institute’s 5th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement, July 11, 2022.
Co-presenter, “Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling,” American Conference Institute’s 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement, July 20, 2020.