Albert F. Cacozza, Jr.

Partner

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  • JD, The University of Chicago Law School, 1982; with honors, Comment Editor, University of Chicago Law Review
  • AB, magna cum laude, Brown University, 1978

Qualifications

  • District of Columbia, 1982
  • Honorable Ruth Bader Ginsburg, U.S. Court of Appeals for the District of Columbia

Albert F. Cacozza, Jr.

Partner

Al provides advice to a variety of life sciences and health care clients on legislative, regulatory and corporate matters. The focus of Al’s practice is FDA regulation of pharmaceuticals, biologics and over-the-counter (OTC) drugs, with special emphasis on issues related to advertising and promotion. He also counsels his life sciences clients on compliance with health care fraud and abuse laws and health information privacy laws. Al provides legal and strategic advice on competitive issues related to product lifecycle management. In recent years, Al has taken a lead role in numerous internal and government compliance investigations.

From 1987 to 1991, Al was Counsel to the Subcommittee on Labor of the U.S. Senate Committee on Labor and Human Resources. Prior to that, he was in private practice focusing on tort liability and administrative law, including extensive work with the special settlement master in the Agent Orange class action litigation.

For nearly 10 years, Al was an adjunct professor at George Washington University Law School, where he taught a course on legislative interpretation.

Experience

  • Assisted a number of pharmaceutical manufacturers in responding to FDA Warning Letters related to false or misleading promotion, including development of corrective action plans and after-event analyses with remedial recommendations.
  • Led an internal safety audit for a national non-profit blood banking organization. 
  • Conducted “deep dive” internal risk assessments of sales and marketing practices for a variety of drug products for numerous pharmaceutical clients. 
  • Managed global health information privacy audits for several large pharmaceutical manufacturers. 
  • Coordinated regulatory due diligence for financial institutions involved in transactions with pharmaceutical, biotechnology and health care companies.
  • Provided legal and strategic advice as part of a multi-disciplinary team advising a pharmaceutical client on switching a prescription drug to OTC status, including preparing the client for an FDA Advisory Committee meeting. 
  • Worked closely with government enforcement litigators as part of a coordinated team conducting internal investigations and addressing government subpoena compliance, including leading witness interviews, analyzing keys document, and developing remedial plans and advocacy responses. 
  • Drafted compliance materials, including standard operating procedures and guidance documents covering fraud and abuse issues, and FDA regulatory issues for a number of pharmaceutical clients manufacturer of specialty pharmaceuticals.

Publications

Presentations