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Partner
Food and Drug
Washington
(202) 955-1575 Phone
(202) 778-7418 Fax
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| Practices |
Food and Drug
Practice
Food Industry
Regulatory Practice
Hatch-Waxman
Practice
Life Sciences
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In October 2007, Sheldon Bradshaw joined Hunton & Williams LLP as a partner and co-chair of the firm's Food and Drug Practice Group. Mr. Bradshaw came to the firm from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel. As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA's senior leadership - including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers - on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA's jurisdiction. At the firm, Mr. Bradshaw advises clients in the same areas in which he worked while Chief Counsel of FDA.
Relevant Experience 
- Advised numerous pharmaceutical companies on drug approval strategies involving new drug applications, 505(b)(2) applications, suitability petitions, and abbreviated new drug applications (ANDAs).
- Counseled clients regarding product life cycle management (including the development of new products and line extensions), Hatch-Waxman issues (including patent and non-patent exclusivities, 30-month stays and FDA's Orange Book); user fees, and risk evaluation and mitigation strategies (REMS).
- Assisted pharmaceutical companies and device manufactures with post-approval issues, including labeling changes, adverse event reporting, good manufacturing requirements (GMPs), and promotional activities.
- Helped clients respond to, and recover from, Warning and Untitled Letters sent by FDA.
- Advised device manufacturers on 510(k) and pre-market approval (PMA) applications.
- Advised clients regarding "intended use" and the types of claims that distinguish drugs and devices from cosmetics and dietary supplements.
- Reviewed labeling of drugs, both Rx and OTC, devices, dietary supplements and cosmetics for compliance with the FD&C Act.
- Counseled clients on legal issues related to the design and implementation of clinical trials, including the preparation of investigational new drug (IND) applications and investigational device exemption (IDE) applications and the submission of information to the clinical trial registry and the new clinical trial results database.
- Provided clients with crisis management counseling on product recalls, government inspections and seizures, and similar issues.
- Represented companies in interactions with regulatory officials from the FDA.
- Assisted companies in criminal, civil, and administrative enforcement actions and related civil litigation involving health care fraud and abuse, qui tam lawsuits, preemption, off-label promotion, misbranding, adulteration, and the anti-kickback statute.
- Retained as an expert witness in a Lanham Act case involving allegations that the advertising for a grandfathered drug product was false or misleading.
- Retained as an expert witness in a Lanham Act case involving allegations that the advertising for a cosmetic rendered the product a drug under the FD&C Act.
- Advised a major pharmaceutical company subject to FDA’s Application Integrity Policy.
- Counseled a client importing food products that were subject to a country-wide Import Alert.
- Assisted a cosmetic company in removing products from an Import Alert.
- Drafted Citizen Petition submitted to FDA.
- Submitted comments on behalf of a major dietary supplement manufacturer to several FDA dockets.
- Represented numerous large, mid-sized, and emerging pharmaceutical, biotechnology, and medical device companies in regulatory matters involving product development and commercialization.
- Represented several clients in disputes with competitors regarding the unlawful advertising and promotion of drug products and medical devices. Submitted trade complaints to FDA objecting to such advertising.
- Provided legal and regulatory advice related to numerous product recalls involving prescription and over-the-counter drug products and food products.
- Counseled clients regarding advertising and promotion issues related to FDA-regulated products, including representing clients before the FDA and reviewing product marketing materials for compliance with FDA regulations.
- Advised client regarding application of FDA's Application Integrity Policy (AIP).
Background
- Chief Counsel, U.S. Food and Drug Administration, 2005-2007
- Principal Deputy Assistant Attorney General, Civil Rights Division, U.S. Department of Justice, 2003-2005
- Deputy Assistant Attorney General, Office of Legal Counsel, U.S. Department of Justice, 2001-2003
- Associate, Howrey Simon Arnold & White, 1999-2001
- Law Clerk, Hon. Karen J. Williams, U.S. Court of Appeals for the Fourth Circuit, 1996-1999
Membership
- Member, District of Columbia and Montana State Bars
- Member, United States Court of Appeals for the Fourth Circuit; United States Court of Appeals for the Fifth Circuit
- Member, Food and Drug Law Institute
Education - J.D., George Washington University Law School, with honors, Managing Editor, The George Washington Law Review, Dean's Fellow, 1996
- B.A., Brigham Young University, Political Science, 1991
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Sheldon Bradshaw
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