Joanne S. Hawana

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications.

Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:

• Determining regulatory status of novel products like mobile health systems and point-of-care diagnostics;
• Pre-market and post-market requirements for various regulated products;
• Restrictions on advertising and sampling, including for controlled substances;
• State licensing schemes for prescription drug manufacturers and distributors;
• Federal track-and-trace obligations for all members of the prescription drug supply chain, from manufacturers to pharmacies;
• Compliance with drug compounding regulations, both State and Federal;
• Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
• Advising on clients’ written submissions to FDA requests for comments or rulemaking activities, and in some cases preparing those submissions on behalf of private companies or patient advocacy groups;
• Requirements for importing and exporting regulated products; and
• Food safety and labeling advice for human and animal food, including dietary supplements and “functional foods,” as well as alcoholic beverage products.

Joanne frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). In recent years, she has been providing ongoing counseling to clients on the impact of sweeping changes to the U.S. food safety system that are being ushered in by the FDA Food Safety Modernization Act, including foreign supplier verification requirements and preventive controls for registered food facilities.

Joanne also assists the Mintz corporate team by performing regulatory due diligence as part of potential mergers and acquisitions that involve regulated companies, and she often works in conjunction with the Firm’s intellectual property attorneys to ensure that patent and regulatory activities are strategically aligned. Although the day-to-day work for clients may be different, the common thread that she enjoys most is helping companies (both start-up and established) bring their products to market – without heightened risks of enforcement actions as a result of non-compliance with sometimes-opaque regulatory requirements.

Prior to joining Mintz, Joanne was an attorney in the food and drug practice in the DC office of another law firm. She had internship experiences during law school at the Biotechnology Industry Organization and the business incubator-focused Maryland Intellectual Property Legal Resource Center. She also spent a summer as a National Institutes of Health Fellow. Before attending law school, Joanne was assistant managing editor of a biomedical research trade publication, and prior to that she was a lab scientist studying the regulation of gene expression and the molecular basis of cancer.

Joanne is a contributor to the Mintz Health Law & Policy Matters blog and an editor of the Consumer Product Matters blog.

• University of Maryland School of Law (JD, cum laude)
• University of Medicine and Dentistry of New Jersey, Graduate School of Biomedical Sciences (MS, Molecular Genetics & Microbiology)
• College of William & Mary (BS, Biology)

• William P. Cunningham Award for Achievement and Service to the School of Law, University of Maryland (2007)
• Manuscripts Editor, The Journal of Health Care Law and Policy (Vol. 10)

• Member, Food and Drug Law Institute (FDLI)
• Chair, FDLI Update Magazine Editorial Advisory Board
• Member, American Bar Association (ABA), and ABA Health Law Section
• Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
• Member, National Association of Professional Women
• Past Chair, FDLI Primer Committee