Cases
Experience: FDA-Related Experience: Conducted FDA-related due diligence for a client's acquisition of a company that markets cosmetics, dietary supplements,
an OTC drug.
Assisted biotechnology company in successfully challenging FDA's denial of its request for orphan drug designation.
Developed federal preemption arguments that persuaded a potential class action plaintiff to not file suit against an OTC drug manufacturer.
Advised prescription drug manufacturer on responding to an FDA Form 483 regarding CGMP issues.
Advised OTC drug manufacturer on responding to an FDA Form 483
Warning Letter regarding CGMP issues.
Advised generic drug manufacturer on issues relating to an FDA Risk Evaluation
Mitigation Strategy (REMS).
Advised prescription drug manufacturer on issues relating to an FDA inspection of one of its manufacturing facilities.
Advised medical device manufacturer on FDA requirements for investigating possible device malfunctions.
On behalf of FDA, won summary judgment or dismissal in three separate cases where generic prescription drug manufacturers sought Hatch-Waxman marketing exclusivity for their products.
On behalf of FDA, won summary judgment where a drug manufacturer challenged an agency interpretation of the Biologics Price Competition
Innovation Act.
Served on a DOJ/FDA trial team that won a six-day trial in the Central District of California where the government obtained a permanent injunction against a drug manufacturer for selling unapproved new drugs.
Via amicus curiae filings on behalf of FDA, won decisions from the U.S. International Trade Commission
the U.S. Court of Appeals for the Federal Circuit holding that the FDCA precluded a prescription drug manufacturer's Lanham Act
Tariff Act claims against dietary supplement manufacturers.
On behalf of FDA, won dismissal of a public interest group's challenge to an agency decision regarding a food labeling regulation.
On behalf of FDA, won dismissal of a public interest group's challenge to an agency decision regarding a cosmetic product.
On behalf of FDA, won dismissal of a consumer's challenge to an agency decision regarding the labeling of a tobacco product.
Advised FDA's Center for Food Safety
Applied Nutrition on its submission in support of a California administrative agency's proposed state regulation exempting coffee from California's Proposition 65 cancer-warning requirement.
Advised FDA's Office of Dietary Supplement Programs on its response to a New Dietary Ingredient Notification.
Advised FDA's Office of New Drugs in resolving a dispute with a prescription drug manufacturer regarding requirements under a REMS.
Advised FDA's Office of Cosmetics
Colors in responding to a Citizen Petition that requested regulatory action regarding a cosmetic product.
Advised FDA's Center for Devices
Radiological Health in responding to a Citizen Petition that requested the agency withdraw its approval of a Class III medical device.
Products Liability Experience: Wrote post-trial motion that resulted in a 99.6% reduction of a $9 billion punitive damages verdict against defendants in a pharmaceutical products liability trial (reported to be the seventh largest punitive damages verdict in U.S. history).
Had primary responsibility for legal briefing in four federal multi-district (MDL) proceedings, two state-wide coordinated proceedings,
many other federal
state cases throughout the country.
Served as a member of on-site motions
/or witness preparation teams for ten multi-week jury trials (including MDL 'bellwether' trials) in Minnesota, Missouri, New York, New Jersey,
Ohio.
The above representations were h
led by Mr. Fraser prior to his joining Greenberg Traurig, LLP.
Government Experience: Associate Chief Counsel for Litigation, U.S. Food
Drug Administration - Office of the Chief Counsel, 2016-2021
Military Experience: U.S. Air Force - Judge Advocate General's Corps, 1995-2001
Appellate Counsel, Air Force Appellate Counsel Division, Washington, DC, 1999-2001
Trial Defense Counsel, Air Force Trial Defense Division, Dover AFB, DE, 1998-1999
Prosecutor, Office of the Staff Judge Advocate, Dover AFB, DE, 1995-1998
Teaching Experience: Adjunct Professor, Written
Oral Advocacy, The University of Maryl
Francis King Carey School of Law, 2019-2020
