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. In recent years she has been advising clients in different industries regarding FDA’s approaches to precision medicine and the impact of the agency’s policies on product development and marketing plans.
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”). She has also been involved in advising and helping clients respond to Federal Trade Commission investigations related to product advertising and requests for substantiation of certain promotional claims.
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. She has developed a distinctive relationship with Mintz attorneys who negotiate royalty monetization transactions and works closely with them in developing the terms for these unique transactions. 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 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, all valuable experiences that make her more attuned to the technical, business, and policy pressures facing companies on the cutting edge of the biotech and med-tech fields.
Joanne is an editor of and frequent contributor to the firm's Health Care Viewpoints.
- 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)
- Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face shields, face masks, and alcohol-based hand sanitizers in compliance with FDA’s enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
- Guided clients developing COVID-19 diagnostic or serological tests on various promotional risks and regulatory obligations both before and after they secure Emergency Use Authorizations from FDA that allow the test to be distributed and used in the United States.
- Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client and helped another client secure Orphan Drug Designation for its innovative drug product.
- Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics. Also assists various companies that market non-prescription consumer products in structuring and implementing their Advertising Compliance Programs and ensuring ongoing risk mitigation in new promotional activities or when launching new products.
Recognition & Awards
- 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)
- Recognized by The Legal 500 United States for Healthcare: Service Providers (2020)
- Member, Food and Drug Law Institute (FDLI)
- Chair, FDLI Publications Committee
- Member, Drug Information Association (DIA)
- Member, American Bar Association (ABA), and ABA Health Law Section
- Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
- Past Chair, FDLI Primer Committee
- Past Chair, FDLI Update Magazine Editorial Advisory Board
News & Press
April 22, 2020 | Blog | By Joanne Hawana
And Now For Something Completely Different: FDA Actions to Alleviate Regulatory Burdens For Product Sponsors During the COVID-19 Pandemic
April 6, 2020 | Blog | By Joanne Hawana
As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.
March 30, 2020 | Blog | By Elizabeth Conti, Joanne Hawana
March 25, 2020 | Blog
March 24, 2020 | Blog | By Christian Tamotsu Fjeld, Joanne Hawana, Karen Lovitch, Joseph Miller, Aaron Josephson
March 18, 2020 | Blog | By Joanne Hawana, Aaron Josephson, Benjamin Zegarelli
We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.