Education
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Southwestern University School of Law, LL.M., 2007
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Brigham Young University School of Law, J.D., cum laude, 2001
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Brigham Young University, B.A., 1998
Bar Admissions
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District of Columbia
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Utah
Clerkships
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Hon. James R. Taylor,
Utah Fourth District Court,
2001
- 2002
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Mr. Nuttall advises a diverse array of clients on a wide variety of FDA-related regulatory, public policy and enforcement matters. He routinely counsels clients engaged in the manufacturing, distribution and sale of prescription and over-the-counter drugs (OTC), dietary supplements, foods, medical devices, cosmetics and tobacco. Additionally, Mr. Nuttall advises clients on related FTC regulatory matters. Prior to joining Patton Boggs, Mr. Nuttall was an Associate Chief Counsel for Enforcement in FDA’s Office of the Chief Counsel, where he represented the FDA in enforcement and defensive litigation matters.
Mr. Nuttall counsels clients regarding FDA regulatory compliance obligations and assists clients to appropriately asses risks related to areas of regulatory ambiguity. Mr. Nuttall’s practice includes providing detailed guidance on client interactions with FDA related to agency oversight and enforcement (e.g., FDA inspections and responses to inspectional observations, Warning Letter responses and negotiations with FDA regarding requests for corrective action). Mr. Nuttall also facilitates client participation in the regulatory process by drafting and submitting Citizen Petitions, commenting on agency rulemakings and guidances, submitting trade complaints and making informal agency contacts to gain additional insight into FDA’s current thinking on specific topics of client interest.
Mr. Nuttall frequently provides counsel regarding FDA and FTC drug advertising and promotional issues, including advice related to PhRMA’s Guiding Principles on Direct to Consumer Advertising and Code on Interactions with Healthcare Professionals. In this unique area of emphasis, Mr. Nuttall has prepared and presented valuable training for clients on prescription drug advertising and promotion.
Representative Matters
FDA
- Drafted Citizen Petition regarding the appropriate bioequivalence standard for a topical generic drug.
- Managed client response to FDA-DDMAC Warning Letter and aided in related negotiations regarding FDA requests for extensive corrective actions.
- Submitted Citizen Petition requesting that FDA apply the 30-month stay provisions of the Hatch/Waxman generic drug amendments to certain “old antibiotic” drugs with newly listed patents.
- Provided comprehensive training for client regarding drug advertising and promotion.
- Submitted comments regarding the appropriate use of laboratory testing in the development of drug risk evaluation and mitigation strategies.
- Detailed counsel regarding client responses to FDA Form 483 lists of inspectional observations.
- Submitted trade complaint regarding over-the-counter drug monograph violations.
- Provided comprehensive label review and regulatory compliance analysis for a major dietary supplement.
- Counseled and submitted comments regarding FDA menu and vending machine nutrition labeling requirements.
FTC
- Developed recycling and other environmental benefits claims, as well as performed a final review of related promotional materials for a medical device product (involving the careful analysis of FTC’s “Green Guides” for the use of environmental marketing claims and in-depth consultation with recycling industry experts).
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