Life Sciences and Healthcare Compliance Lawyer Keith Korenchuk Joins Arnold & Porter
Compliance and Enforcement Experience Adds Depth to International FDA and Healthcare Group
Washington, DC, February 5, 2009 -- Arnold & Porter LLP announced today that life sciences and healthcare compliance lawyer Keith Korenchuk has joined the firm as a partner in the Washington, DC office. Mr. Korenchuk has substantial experience advising major pharmaceutical, medical device, and healthcare companies on compliance programs and related enforcement issues.
"We are delighted that Keith is joining us," said Daniel Kracov, head of the US FDA and Healthcare Practice. "Keith is a highly respected leader in the life sciences and healthcare compliance world. His background in global compliance efforts is of growing importance to our clients in the life sciences and healthcare provider industries, and complements the skills and experience of our growing FDA and healthcare team."
"Keith is a leader in developing global regulatory compliance programs for major companies who operate in multiple jurisdictions around the world," said Ian Dodds-Smith, head of the EU Food, Drug and Medical Device and Product Liability Practices. "He is highly regarded on both sides of the Atlantic for his deep understanding of compliance issues that cut across several areas of legal practice, including corporate conduct, anti-bribery issues, and other post-marketing regulatory requirements that can trigger sanctions not only under EU law and industry codes of practice, but also under US law."
Mr. Korenchuk has in-depth experience in US and global compliance systems design, implementation, and ongoing assessment; regulatory matters involving healthcare professionals, including fraud and abuse and issues related to off-label promotion; global anti-bribery legislation, including the US Foreign Corrupt Practices Act; state legislation involving pharmaceutical and medical device marketing and disclosure; and internal and government initiated investigations. He has provided counsel in the negotiation of Corporate Integrity Agreements (CIAs) with the Office of the Inspector General of the US Department of Health and Human Services, as well as providing support of CIA implementation, ongoing operation, and related OIG site visits. He has assisted global pharmaceutical and medical device companies in conducting overall program evaluations for subsidiaries in Europe, the Middle East, Latin America, and Asia, as well as assisting in remediation efforts.
Mr. Korenchuk is a graduate of the University of Virginia Law School and holds a master's degree in public health from Harvard University. He has been in private law practice for the majority of his career, but he also has served as CEO of organizations focusing on pharmaceutical and healthcare sector compliance, as well as technology research and development.
"Arnold & Porter's strong, international reputation in the life sciences industry and its breadth and depth of experience in regulatory, enforcement, and litigation matters is matched by few others in the industry," said Mr. Korenchuk. "I am excited to be joining a firm that demonstrates an integrated and strategic approach in helping clients solve issues critical to their business growth, and one where I can grow my practice."
The firm's healthcare practice has enjoyed notable growth over the past year with the addition of a four-person healthcare regulatory team: Alan Reider, Allison Shuren, Paul Rudolf, and Thomas Gustafson; New York healthcare lawyers Jeffrey Ruggiero and Andrew Bogen; former Associate Chief Counsel in the US Food and Drug Administration's Office of Chief Counsel Vernessa Pollard; and several associates.
With the addition of these healthcare team members, more than 40 lawyers from the firm's FDA and Healthcare group are now practicing in the US and Europe, many of whom have government agency experience or have previously served as medical doctors, nurses, scientists, and public policy specialists. The group serves clients in the pharmaceutical, biotechnology, and medical device industries, as well as hospitals, physician groups, and other healthcare services providers. The team has in-depth experience in advising on complex regulatory and compliance challenges with the ability to handle the regulatory aspects of transactions and commercial litigation.