D. Kyle
Sampson

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.