Delia A. Deschaine

Delia A. Deschaine

Senior Associate
Washington, D.C.

Email delia.deschaine@​hoganlovells.com

Phone +1 202 637 5547

Fax +1 202 637 5910

Practice groupGlobal Regulatory

Delia Deschaine understands the most significant U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) legal and compliance risks 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 action. She routinely counsels pharmaceutical and biotechnology companies, including manufacturers, wholesalers, pharmacies, researchers, and others on their regulatory obligations under the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act, including compliance with current Good Manufacturing Practices (cGMP) and the DEA's expectations related to Suspicious Order Monitoring. Delia also advises clients on the federal and state regulation of cannabis, including hemp and hemp-derived products.

Delia has traveled the globe to assist clients in responding to problematic FDA inspections, including responding to Form FDA 483s and Warning Letters. She routinely assists clients in developing, implementing, and managing corrective action plans, and her clients acclaim her leadership and strategic thinking skills in doing so. She is well-versed on the requirements of cGMP as they apply to aseptic processing, quality risk management, supplier management, and data integrity.

Prior to joining Hogan Lovells, Delia was an attorney at a prominent boutique FDA regulatory law firm in Washington, D.C., where she represented pharmaceutical, medical device, and biotechnology companies in FDA and DEA enforcement actions and litigation. She also served as an Attorney Advisor for the DEA, as a fellow in the U.S. Attorney General's Honors Program.

In law school, Delia 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 is active in the firm's Pro Bono practice.

Delia has an undergraduate degree is clinical psychology, was a teaching assistant for Statistics for Social Sciences, and designed and conducted a non-clinical study of the effects of chronic ethanol administration on object recognition and learning.

Awards and recognitions

2011

Performance Award
U.S. Dept. of Justice, DEA

2018-2019

Rising Star, Food & Drugs
Super Lawyers

Education and admissions

Education

J.D., University of Maryland, Francis King Carey School of Law, cum laude, Health Law Certificate, Health Law Moot Court, 2010

B.A., Manhattan College, Board of Trustees Scholar, 2000

Memberships

Member, New to Food and Drug Law Planning Committee, Food and Drug Law Institute (2018-2019)

Bar admissions and qualifications

District of Columbia

Maryland

Representative experience

Held leading role in high-profile government investigation and subsequent litigation involving wholesaler's compliance with the DEA's supicious order monitoring requirements.*

Represented a pharmacy chain in civil, criminal, and administrative investigations regarding compliance with the Controlled Substances Act and Combat Methamphetamine Epidemic Act.

Represented several manufacturers in responding to Form FDA 483s and Warning Letters, in every case resulting in no (or no further) enforcement action from the FDA.

Advised pharmaceutical manufacturer on compliance with the DEA's expectations related to suspicious order monitoring.

Advised several clients on the federal and state regulation of cannabis, CBD, hemp, and hemp-derived products and conducted regulatory diligence in transactions related to same.

Assisted a client in submitting an application to DEA to cultivate cannabis for research in the U.S.

Represented a client in obtaining a letter from the DEA finding that the client's development cannabinoid drug product was not classified as Schedule I.

*Matter handled prior to joining Hogan Lovells.

Loading data