Deborah M. Shelton

Deborah M. Shelton is a Special Counsel in the Food and Drug Team in the firm's Washington, D.C. office. Ms. Shelton concentrates her practice in the area of FDA and DEA law, with a particular emphasis on drugs, biological products, and medical devices.

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 regulatory compliance and post-marketing. She has extensive experience in evaluating and developing marketing strategies for new products, including 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. Her client work also encompasses a full range of regulatory issues relevant to the pharmaceutical and medical device industries, including listing and registration, user fees, reporting and recordkeeping requirements, import-export issues, cGMPs, and OTC monograph 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.

In addition to counseling clients on FDA regulations, 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.

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. Along with her regulatory counseling, Ms. Shelton has participated in extensive litigation involving these same issues.

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. Most recently, Deborah represented a pharmaceutical company in an administrative hearing before DEA, where she secured for the company a highly contested registration to import certain pharmaceutical raw materials. Following a challenge by competitors, DEA’s grant of registration was upheld by the U.S. Court of Appeals.

Ms. Shelton has spoken and authored numerous FDA-related issues, including non-patent exclusivities, patent listing and certification requirements, patent term extensions, advertising and promotion of drugs and medical devices, import-export issues, as well as on the current debate concerning the possible creation of an abbreviated approval pathway for a generic version of biological products.

Education

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

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

Articles

• A National, Uniform Paper Trail for Drugs?, 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)
• “Biogenerics Update,” Pharma & Bio Ingredients, July/August 2005
• “The Continuing Debate Over Follow-On Biologics,” FDLI Update, May/June 2005
• “Moving Toward Biogenerics?” Pharma & Bio Ingredients April/May 2005
• “Moving Toward Biogenerics in the U.S.,” Pharma & Bio Ingredients, March/April 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, "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
• Panel Moderator, “Intellectual Property of and Market Exclusivity for Biologics,” FDLI Conference on Regulatory Schemes for Follow-On Biologics, Washington, D.C., November 2005
• 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, "Whither Biogenerics," SRI Biopharmaceutical Global Summit, Washington, D.C., 8/3/05
• 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, “The Abbreviated NDA and Patent Exclusivity Issues,” FDLI Introduction to Drug Law and Regulation, Washington, D.C., 6/7/05
• Speaker, “Biogenerics? When? How?” Conference on Plant Made Pharmaceuticals, Montreal, Canada, 1/30/05 – 2/2/05
• Speaker, “Legal and Regulatory Framework for Generic Biologics,” CBI Biogenerics Conference, Washington, D.C., 7/19/04 – 7/20/04
• Panel Moderator, “Investigate How Generic Companies View the Complexities of Biogenerics,” CBI Biogenerics Conference, Washington, D.C., 7/19/04 – 7/20/04
• “Biogenerics and the FDA – Potential Pathways/Legal and Regulatory Challenges,” CBI Biogenerics Conference, Washington, D.C., July 2004
• Workshop Leader, “Brand v. Generic: The Battle for Exclusivity,” FDLI Introduction to Drug Law and Regulation, Washington, D.C., 6/15/04
• Speaker, “The Abbreviated NDA and Patent Exclusivity Issues,” FDLI Introduction to Drug Law and Regulation, Washington, D.C., 6/14/04
• Speaker, “Generic Biologics: Overview of Legal and Regulatory Issues,” Practicing Law Institute’s Biotechnology Law 2003: Biotechnology Patents & Business Strategies, New York, 9/03