As appeared in Journal of Health & Life Sciences Law, January 2010.
ABSTRACT: Investment and merger activity in the life sciences sector is strong, even in a weakened economy. At the same time, large losses associated with government settlements, investigations, and civil litigation have raised the stakes associated with investments in these companies. This article includes a discussion of the legal and regulatory concerns that differentiate investments in the life sciences sector from those in other industries, and recommendations for conducting due diligence reviews of life sciences companies. Key compliance considerations for life sciences companies include litigation and government enforcement risks; corporate compliance program considerations; U.S. Food and Drug Administration compliance; government rebate, reimbursement, and procurement programs; fraud and abuse; and state law compliance. Recommendations include considerations for preparing for and conducting a due diligence review of a life sciences company and for utilizing due diligence findings to influence the transaction.
J. Health & Life Sci. L., January 2010, at 52. © 2010 American Health Lawyers Association, http://www.healthlawyers.org/JHLSL. All rights reserved.