People

Kyle Sampson focuses on Food and Drug Administration regulatory, compliance and enforcement issues. As a partner in our FDA and Life Sciences practice, Kyle represents companies in the full range of regulatory and enforcement issues.

Kyle advises food, drug, biologics, medical device, cosmetics and dietary supplement companies on FDA compliance, regulatory and enforcement matters. His practice also includes strategic advice and compliance counseling, enforcement, litigation and transactional matters.

Kyle has engaged in extensive public service in every branch of the federal government. He served in the White House as Associate Counsel to the President; at the Department of Justice as a Special Assistant U.S. Attorney and as Counselor and Chief of Staff to two attorneys general; and in the U.S. Senate as Counsel to the Senate Judiciary Committee.

 

 

Full Bio

Credentials

J.D., University of Chicago Law School, with honors

B.A., Brigham Young University

District of Columbia

U.S. Court of Appeals for the D.C. Circuit

U.S. Court of Appeals for the Eleventh Circuit

U.S. Court of Appeals for the Fourth Circuit

U.S. District Court for the District of Utah

Utah

Law Clerk, Hon. Karen J. Williams, U.S. Court of Appeals for the Fourth Circuit

Attorney General’s Award for Outstanding Service to the Attorney General, the Department of Justice, and to America


U.S. Department of Justice, 2005

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Recognition

Attorney General’s Award for Outstanding Service to the Attorney General, the Department of Justice, and to America


U.S. Department of Justice, 2005

Matters

Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions.

Serve as counsel to pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization.

Represent pharmaceutical and medical device manufacturers in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters.

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Matters

Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions.

Serve as counsel to pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization.

Represent pharmaceutical and medical device manufacturers in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters.

Serve as compliance counsel for a pharmaceutical company subject to consent decree resulting from allegation that company provided false scientific data to FDA in regulatory submissions.

Represent a medical device manufacturer in consent decree negotiations with FDA and Department of Justice.

With Monitor appointed by U.S. Attorney’s Office for the District of New Jersey under Deferred Prosecution Agreement (DPA), oversaw orthopedic device manufacturer's compliance with federal Anti-Kickback Statute and other federal healthcare laws and its implementation of comprehensive compliance program.

Review advertising and promotional materials and activities for prescription drugs, biologics and devices for various clients.

Provide advice to manufacturers of controlled substances and listed chemicals regarding compliance with the Controlled Substances Act and Drug Enforcement Administration regulations.

Represent manufacturers of drug, medical device, human food, animal feed and consumer products in negotiations with the FDA over recalls of manufacturers’ products, including proper classification of recall, assessment of health hazard, and development and implementation of recall strategy.

Represent foreign manufacturers and domestic importers in responding to the FDA’s detention of imports and placement of firms on Import Alert, including negotiating firms’ removal from Detention Without Physical Examination (DWPE).

Help pharmaceutical and medical device companies respond to widespread counterfeiting of products and unlawful importation by Internet pharmacies and others in violation of the Federal Food, Drug, and Cosmetic Act and the Lanham Act.

  • Provided advice to two attorneys general on legal and policy issues, coordinated Justice Department positions in criminal prosecutions and civil litigation, and formulated and implemented policy initiatives and legislative proposals.

As Special Assistant U.S. Attorney, conducted trial and appellate litigation, including arguing three cases in the U.S. Courts of Appeals for the Fourth and Ninth Circuits.

Matters

Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions.

Serve as counsel to pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization.

Represent pharmaceutical and medical device manufacturers in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters.

See more
Icon close

Close

Matters

Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions.

Serve as counsel to pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization.

Represent pharmaceutical and medical device manufacturers in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters.

Serve as compliance counsel for a pharmaceutical company subject to consent decree resulting from allegation that company provided false scientific data to FDA in regulatory submissions.

Represent a medical device manufacturer in consent decree negotiations with FDA and Department of Justice.

With Monitor appointed by U.S. Attorney’s Office for the District of New Jersey under Deferred Prosecution Agreement (DPA), oversaw orthopedic device manufacturer's compliance with federal Anti-Kickback Statute and other federal healthcare laws and its implementation of comprehensive compliance program.

Review advertising and promotional materials and activities for prescription drugs, biologics and devices for various clients.

Provide advice to manufacturers of controlled substances and listed chemicals regarding compliance with the Controlled Substances Act and Drug Enforcement Administration regulations.

Represent manufacturers of drug, medical device, human food, animal feed and consumer products in negotiations with the FDA over recalls of manufacturers’ products, including proper classification of recall, assessment of health hazard, and development and implementation of recall strategy.

Represent foreign manufacturers and domestic importers in responding to the FDA’s detention of imports and placement of firms on Import Alert, including negotiating firms’ removal from Detention Without Physical Examination (DWPE).

Help pharmaceutical and medical device companies respond to widespread counterfeiting of products and unlawful importation by Internet pharmacies and others in violation of the Federal Food, Drug, and Cosmetic Act and the Lanham Act.

  • Provided advice to two attorneys general on legal and policy issues, coordinated Justice Department positions in criminal prosecutions and civil litigation, and formulated and implemented policy initiatives and legislative proposals.

As Special Assistant U.S. Attorney, conducted trial and appellate litigation, including arguing three cases in the U.S. Courts of Appeals for the Fourth and Ninth Circuits.

Credentials

J.D., University of Chicago Law School, with honors

B.A., Brigham Young University

District of Columbia

U.S. Court of Appeals for the D.C. Circuit

U.S. Court of Appeals for the Eleventh Circuit

U.S. Court of Appeals for the Fourth Circuit

U.S. District Court for the District of Utah

Utah

Law Clerk, Hon. Karen J. Williams, U.S. Court of Appeals for the Fourth Circuit

Attorney General’s Award for Outstanding Service to the Attorney General, the Department of Justice, and to America


U.S. Department of Justice, 2005

Icon close

Close

Recognition

Attorney General’s Award for Outstanding Service to the Attorney General, the Department of Justice, and to America


U.S. Department of Justice, 2005