(May 7, 2007, Oakland, CA, and Washington, D.C.) – Two partners at Reed Smith, one of the 15 largest law firms in the world, are celebrating the release of the new edition of Recalls of Prescription Products: A Proactive Primer, recently released by the Food and Drug Law Institute (FDLI).
James M. Wood, a partner in the firm’s Oakland office, and Areta L. Kupchyk, a partner in the firm’s Washington, D.C. office, co-authored the updated work in collaboration with attorney David Bloch. Both Mr. Wood and Ms. Kupchyk are members of Reed Smith’s Food and Drug Administration (FDA) Drug and Device Practice.
The Primer walks readers through the pharmaceutical recall process in concise, understandable language. Working references to statutes, legislative history, guidance documents, websites and regulatory manuals are included to provide the background and resource materials readers need to successfully conduct recalls within their own companies. The work discusses aspects of the recall of prescription products (e.g., medicines, devices, biologics, electronic products, and human tissue) and includes chapters on crisis planning, liability, and insurance realities.
“This is an outstanding contribution to the pharmaceutical practice literature,” said Carol Loepere, Head of Reed Smith’s Health Care Group. “This updated information is important both to pharmaceutical companies and medical device manufacturers, as well as to those of us in the legal profession who represent these corporations’ interests worldwide. It was a significant undertaking to pull all this information together, and readers of the Primer will immediately appreciate the thoroughness and currency of this information.”
Highlights of the new edition include a review of updates to recall procedures in the Compliance Program, Manual for FDA Staff and the FDA/ORA Regulatory Procedures Manual ; review and update of new FDA regulations including the use of electronic notification of recalls; an update and development of insurance coverage available for recalls; suggestions for creating a proactive plan and team before a recall happens ; analysis of product liability issues arising from prescription product recalls as well as a summary of the law to exclude evidence of recalls; and analysis of recall issues for human cell, tissue, and cellular - and tissue-based products.
Mr. Wood has focused his practice on the representation of manufacturers of prescription medicines and medical devices for more than three decades. His practice includes representing and counseling manufacturers of prescription products involving a variety of issues. These have included recalls of prescription products, marketing and promotion of these products, first amendment issues in marketing these products, off-label issues, preemption, product liability issues and the reuse of single use medical devices.
Ms. Kupchyk’s practice focuses on FDA regulatory issues. She counsels on drug, device, biologics, and biotechnology matters and her experience includes product application issues, human cellular and tissue product regulation, xenotransplantation, and fast track approvals. Ms. Kupchyk also has extensive experience with advertising and compliance issues, including GMP inspections, validation requirements, recall orders, application integrity, and debarments.
“This new edition is designed as a guidebook for companies that sell regulated prescription products, who must be prepared to recall those products if a problem arises,” said Mr. Wood.
Ms. Kupchyk added, “To manage the recall process, they have to be aware of the potential repercussions—business, legal and regulatory—of undertaking the recall process. This updated edition will help them navigate the often complex recall labyrinth.”
Ordering information for the 298-page handbook is available from FDLI online at http://www.fdli.org/pubs/recall/.
About Reed Smith
Reed Smith is one of the 15 largest law firms in the world, with more than 1,500 lawyers in 21 offices throughout the United States, Europe and the Middle East. Founded in 1877, the firm represents leading international businesses from Fortune 100 corporations to mid-market and emerging enterprises. Its attorneys provide litigation services in multi-jurisdictional matters and other high stake disputes, deliver regulatory counsel, and execute the full range of strategic domestic and cross-border transactions. Reed Smith is a preeminent advisor to industries including financial services, life sciences, health care, advertising and media, shipping, international trade and commodities, real estate, manufacturing and education. For more information, visit reedsmith.com
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