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.

Presentations

Publications

Co-author, “Incentives And Risks From OTC Drug Monograph Revamp” Law360 (May 29, 2020)

Co-author, “Proposed FDA Drug Software Rules Strict On Pharma Companies,” Law360 (December 10, 2018)

Co-author, “A Closer Look At CMS' Drug Price Disclosure Proposal,” Law360 (October 24, 2018)

Co-author, “FDA Clarifies Communication Rules for Medical Product Cos.,” Law360 (June 21, 2018)

Cited, “The New U.S. Department of Health and Human Services: Tom Price and Value-Based Health Care,” JD Supra Business Advisor (January 6, 2017)

Cited, “The New FDA: Product Development, Pricing and Beyond,” JD Supra Business Advisor (January 6, 2017)

Quoted, “Trump ‘Wild Card’ in Drug Price Debate: Attorney,” Dickinson’s FDA Webview (January 3, 2017)

Quoted, “Life Sciences Legislation and Regulation to Watch in 2017,” Law360 (January 2, 2017)

Quoted, “Digital Health Faces Uncertain Federal Oversight,” Bloomberg BNA Health IT Law (August 29, 2016)

Co-author, “FDA And Digital Health: Time For A Cultural Exchange,” Law360 (May 31, 2016)

Co-author, “Big Data and HIPAA Privacy–Threshold Questions to Ask,” Pharmaceutical Compliance Monitor (March 21, 2016)

Co-author, “National Institutes of Health Issues a Notice of Proposed Rulemaking on Clinical Trials Registration and a Draft Policy on Registration and Reporting of Results for NIH-Funded Clinical Trials,” Bloomberg BNA’s Medical Law & Policy Research Report (December 2014)

Contributor, PLI’s Pharmaceutical Compliance and Enforcement Answer Book 2014 (December 2013)

Co-author, “Drug Promotion in the Post-Caronia World,” Food and Drug Law Institute’s (FDLI) Update magazine (March/April 2013)

Presentations

Presenter, “From Innovation to Solutions: Building Strategic Partnership in an Evolving Digital Health Landscape,” Ropes & Gray Digital Health Forum (September 18, 2019)

Speaker, “Outlook 2018 Teleconference: The Trump Administration’s Impact on Life Sciences and Health Care—the First Year,” Ropes & Gray Teleconference (January 23, 2018)

Speaker, “Outlook 2017: The New Administration and Its Impact on Life Sciences and Health Care,” Ropes & Gray Teleconference, January, 2017

Speaker, "FDA & Regulatory Issues Facing Medical and Lifestyle Devices and Apps," Ropes & Gray West Coast Lunchtime Legal Briefing Teleconference, October 2014

focus on:

Health Reform Resource Center