News

Arnold & Porter Expands Pharmaceutical and Medical Device Group

November 7, 2005

Washington, D.C., November 7, 2005 – Arnold & Porter LLP announced today the expansion of its pharmaceutical and medical device practice with the addition of two prominent professionals to its Washington, DC, office. Daniel Kracov will join the firm as a partner and co-head of the Pharmaceutical and Medical Device practice group in the US and Kathleen Means will serve as a non-lawyer senior policy advisor. Both join from a major law firm in Washington.

Mr. Kracov and Ms. Means will enhance the firm’s ability to assist clients with FDA approvals, government investigations, legislative strategies, health insurance benefits, coverage, reimbursement, and pricing issues for manufacturers of biologics, pharmaceuticals, and medical devices. Their work also will interface with such areas of firm strength as product liability, intellectual property, antitrust, and transactions, and will further solidify Arnold & Porter’s position as the “go to” firm for matters at the intersection of public policy, law, and business.

“Dan and Kathy bring great depth, leadership, and energy to the firm,” said Chairman Michael Sohn. “They will broaden our platform for providing comprehensive advice to clients in the pharmaceutical and medical device sector, not in just one area, but in the often inter-related areas of FDA counseling, Medicare and private payer coverage and reimbursement, pricing, fraud and abuse, and public policy.”

Mr. Kracov’s expertise in FDA product approval, strategic advice, and crisis management won him a spot on the recent Legal Times list of “Leading Lawyers in Food & Drug Law” this fall. Mr. Kracov served as the head of the FDA group at his former firm. He has assisted clients on matters involving the regulation of drugs, biologics, medical devices, foods, and cosmetics. He has handled FDA and Congressional investigations and legislative initiatives, including the reauthorization of the Prescription Drug User Fee Act and amendments to the Hatch-Waxman generic drug legislation. He served as counsel to scientific investigators in the aftermath of the death of a clinical subject and represented investigators in five separate governmental and private investigations. He received a JD from the University of Virginia School of Law.

Long a leader in the healthcare policy field, at her former firm, Ms. Means consulted with clients on highly complex public policy matters in the areas of Medicare and Medicaid, healthcare finance, insurance, and prescription drug and medical device issues, including coverage and reimbursement strategies. Prior to that position, she directed the healthcare staff for the Republican majority on the US Senate Finance Committee after serving two years on the House Ways and Means Committee. She also held a Senior Executive Service position at the Center for Medicare and Medicaid (CMS), the agency responsible for administering the Medicare and Medicare programs. She worked on legislative and CMS issues, developing legislative strategies and assisting with the development of launch plans for new drugs. She also worked as National Health Benefits Manager in the Blue Cross Blue Shield system, gaining experience in health insurance contracts, product support, and benefits issues. She regularly lobbies on the Hill and before the Department of Health and Human Services (HHS) on healthcare issues. She has a BS in Economics from Arizona State University.

Arnold & Porter has an international reputation in serving the pharmaceutical and medical technology industries. The US regulatory practice will be jointly led by Daniel Kracov and Dara Corrigan, former Acting Inspector General at the Department of Health and Human Services, who joined the firm last fall. Ms. Corrigan’s career has focused primarily on protecting the integrity of Medicare/Medicaid programs from healthcare fraud and abuse. The firm’s regulatory practice has several attorneys who are also physicians or trained scientists. A number of them have served in federal agencies, including former FDA lawyers Donald Beers, Arthur Levine, and William Vodra.

Mr. Vodra has headed up Arnold & Porter’s FDA group for more than ten years and also was recently named to the Legal Times list of “Leading Lawyers in Food & Drug Law.” Mr. Vodra’s and Mr. Levine’s recent article on the FDA’s renewed use of disgorgement as an enforcement procedure won a 2005 Burton Award for Legal Achievement.

The U.S. group collaborates with Arnold & Porter's European Regulatory and Product Liability practice group, based in London. Headed by Ian Dodds-Smith, this team has 12 professionals, including medical doctors and specialists. The group is recognized throughout the world for their product liability and EU regulatory experience in pharmaceuticals and other medical products.

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