Deborah M. Shelton

Deborah M. Shelton is a partner in the Food and Drug Group in the firm's Washington, D.C. office. She serves as co-leader of the firm's Life Sciences group. Ms. Shelton concentrates her practice in the area of FDA and DEA law, with a particular emphasis on drugs, biological products, and medical devices. Ms. Shelton's practice also focuses on products regulated by other agencies and regulatory bodies, including the CPSC, USDA, U.S. Customs, and NHTSA.

Areas of Practice

Ms. Shelton counsels manufacturers and distributors of drugs, biological products and medical devices on issues related to all phases of product development and approval, from the investigational stage to FDA approval and post-marketing.  As part of her work on the investigational side, Ms. Shelton provides regulatory counseling on all aspects of the FDA approval process, including the conduct of clinical trials, drafting Clinical Trial, Informed Consent, and Master Service Agreements, and advising on clinical trial issues such as adverse event reporting and clinical holds.  On the post-marketing side, Ms. Shelton has extensive experience in evaluating and developing marketing strategies for new products, including labeling review and counseling on advertising and promotional materials and strategies. Ms. Shelton regularly advises clients on the statutory and regulatory standards governing marketing applications for drugs, biological products and medical devices, and related compliance and import-export issues.  As a regular part of her compliance work, she has conducted numerous due diligence audits of clients’ acquisition targets, and has defended against various types of government enforcement actions. Ms. Shelton provides ongoing regulatory counseling on FDA implementation and regulatory requirements pursuant to the Food and Drug Administration Amendments Act of 2007 (FDAAA), including REMS, post-market study and clinical trial requirements, and expanded clinical trial registry and results databank requirements. 

Ms. Shelton devotes a significant portion of her practice to advising pharmaceutical companies on market exclusivities, such as new chemical entity, orphan drug, and pediatric exclusivities. In addition to these non-patent exclusivities, she regularly counsels pharmaceutical companies on the complex array of issues arising under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, including patent listing and patent term extensions. Ms. Shelton has participated in extensive litigation involving these same issues.

Ms. Shelton provides counseling on the DEA regulation of controlled substances and precursor chemicals. In this work, she advises on the Controlled Substances Act and other federal and state laws, regulations, and policies governing the scheduling, manufacturing, distributing, and importing and exporting of controlled substances and precursor chemicals.

She has taken part in numerous civil trials and administrative hearings, as well as agency rulemaking and adjudicatory proceedings before the FDA and DEA, and in federal courts. 

In addition to FDA and DEA, Ms. Shelton's practice focuses on products regulated by other agencies, including the U.S. Department of Agriculture (USDA), U.S. Customs and Border Protection (CBP), the Consumer Product Safety Commission (CPSC), and the National Highway Transportation Safety Administration (NHTSA). This work includes advising clients on the Consumer Product Safety Improvement Act (CPSIA), product recalls, and import-export issues.

Ms. Shelton has spoken and written extensively over the years on a host of FDA and other regulatory issues, including advertising and promotion of drugs and medical devices, import-export, Hatch-Waxman, and more recently, CPSIA.

Education

• J.D., University of Maryland Law School, 1998, with honors
• B.S., University of Maryland, 1994, summa cum laude

Admissions

• District of Columbia
• Maryland
• U.S. District Court of Maryland
• U.S. District Court for the District of Columbia
• U.S. Court of Appeals for the District of Columbia Circuit

Memberships

• Elected to the Steering Committee of the D.C. Bar’s Administrative Law and Agency Practice Section
• Appointed to the Advisory Board of BNA’s Pharmaceutical Law and Industry Report
• Serves on the Food and Drug Law Institute’s Thomas H. Austern Law Student Writing Competition Committee
• Maryland Bar Association
• DC Bar Association, Administrative Law and Agency Practice
• American Bar Association, Administrative Law and Regulation Practice; Health Law; Intellectual Property Law

Articles

• The FDA's New Reportable Food Registry, Law 360, October 7, 2009

• A National, Uniform Paper Trail for Drugs?, Legal Times, October 9, 2006

• "Follow-on Biologics: Non-Patent Market Exclusivity in the U.S. and EU, " FDLI Update, July/August 2007 (co-author with Melinda Friend)

•  "Follow-on Biologics Defined," ISPE Los Angeles Chapter Newsletter, Vol. 13 (4), May 2006

•  "Biogenerics: Development of U.S. Regulatory Scheme May Soon Gain Traction," Chemistry Today," March/April 2007

•  “Stem Cells: In Search of Global Harmonization,” Pharma & Bio Ingredients, September/October 2005

• SRI Biogenerics Conference [Abstract], Thomas Scientific, (August 2005)

•  “The Continuing Debate Over Follow-On Biologics,” FDLI Update, May/June 2005 

•  “FDA Reaffirms Its Interpretation of FFDCA Section 505(b)(2),” Analysis & Perspective, BNA’s Pharmaceutical Law & Industry Report 1.44 (11/21/03)

Speeches

• Presenter, "Food and Drug Administration Amendments Act of 2007 (FDAAA) – Clinical Trial Databases and Postmarket Safety Requirements," FDLI Introduction to Biotechnology Law and Regulation, Washington, D.C., May 28-29, 2009
• Presenter, "90 Days Until Destruction: How to Release an Import Hold," FDANews Audioconference, January 28, 2009
• Presenter, " FDAAA (FDA Amendments Act of 2007)," FDA-OCRA Educational Conference, Irvine, CA, June 11-12, 2008
• Presenter, "But Wait - Is The U.S. Finally Catching Up With The EU? A Look At Recently Proposed U.S. Legislation As Potential Indicator," Biogenerics 2007, London, UK, May 22, 2007
• Presenter, "Biogenerics" or "Follow-on Biologics" in the U.S.: What does the Future Hold?", ISPE LA Chapter 14th Annual Vendor Night, Burbank, CA, May 16, 2007
• Speaker, Deutsche Bank's Healthcare Conference, "Biogenerics: The Evolving Regulatory Landscape," Washington, D.C., May 2-3, 2007
• Moderator, FDLI's 50th Anniversary FDLI & FDA Conference, "FDA's Center for Biologics Evaluation and Research (CBER) Director Panel," April 13, 2007, Washington, D.C.
• Presenter "Hatch-Waxman: At the Intersection of FDA and Patent Law," FDLI, Washington, D.C., Nov. 8-9, 2006
• Presenter "Biogenerics in the U.S.: Complexities and Challenges," APIs Europe Conference, Cernobbio, Italy, June 20-23, 2006
• Presenter, "Patent and Non-Patent Market Exclusivities for Biological Pharmaceuticals," at FDLI sponsored conference "Introduction to Biotechnology Law and Regulation Workshop: Focusing on Human Biologicals and Drugs," May 1, 2006, Washington, D.C.
• Panel member, "Medical Device Advertising: Lessons Learned from Untitled Letters," February 16, 2006, FOI Services Audioconference
• Co-presenter, "Designing a 'Hatch-Waxman' Protocol for Follow-on Biologics," at ACI's 6th Advanced Forum on Biotech Patents: Constructing the Plan for the Future," Feb. 16-17, 2006 in San Francisco, California
• Co-Presenter, “Off-Label Promotion: What Corporate Counsel Need to Know,” Drug and Medical Device Litigation Conference, New York, NY, 10/25/05-10/26/05
• Speaker, “Import-Export,” FDLI Introduction to Biotechnology, San Francisco, California, 6/15/05
• Workshop Leader, “Brand v. Generic: The Battle for Exclusivity,” FDLI Introduction to Drug Law and Regulation, Washington, D.C., 6/8/05
• Speaker, “Biogenerics? When? How?” Conference on Plant Made Pharmaceuticals, Montreal, Canada, 1/30/05 – 2/2/05