Kyle is a partner in the Washington office and a member of the firm’s food and drug practice. His practice focuses on FDA regulatory, compliance and enforcement issues. Kyle represents food, drug, biologics, medical device, cosmetics and dietary supplement companies on the full range of regulatory and enforcement issues confronting FDA-regulated firms. His practice also includes strategic advice and compliance counseling, enforcement, litigation and transactional matters.
During his professional career, Kyle has engaged in extensive public service in every branch of the federal government, serving in the White House from 2001 to 2003 as Associate Counsel to the President, and at the Justice Department from 2003 to 2007 as a Special Assistant US Attorney and as Counselor and Chief of Staff to two Attorneys General. Kyle also served as Counsel to the US Senate Judiciary Committee from 1999 to 2001. After law school, Kyle clerked for the Hon. Karen J. Williams of the US Court of Appeals for the Fourth Circuit.
Kyle’s pro bono experience includes representing refugees in asylum proceedings in Immigration Court and before the Board of Immigration Appeals.
- Conducted comprehensive internal review of allegations that pharmaceutical company failed to comply with good laboratory practices (“GLPs”) and committed other wrongful acts that could call into question the integrity of scientific data provided by the company to FDA in regulatory submissions.
- Serve as counsel to several mid-sized and emerging pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization.
- 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.
- With Monitor appointed by US 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.
- Serve as compliance counsel for pharmaceutical company subject to consent decree resulting from allegation that company provided false scientific data to FDA in regulatory submissions.
- Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving federal healthcare program reimbursement and pricing, off-label promotion, anti-kickback violations and false claims actions.
- Advise pharmaceutical manufacturers on compliance with federal and state marketing disclosure laws, including developing in-house systems to identify, aggregate, and disclose firms’ payments to healthcare practitioners in the form of gifts, grants, honoraria, food, consulting fees and travel.
- Represent manufacturers of drug, medical device, human food, animal feed, and consumer products in negotiations with 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 FDA’s detention of imports and placement of firms on Import Alert, including negotiations of 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 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 US Attorney, conducted trial and appellate litigation, including arguing three cases in the US Courts of Appeals for the Fourth and Ninth Circuits.