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.
More Legal and Business Bylines From Joanne S. Hawana