Joanne counsels global clients on various regulatory and distribution-related considerations related to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized, including with respect to advertising and promotion. She also advises on the business impact of new US federal and state actions that affect regulated products, such as drugs, biologics, regenerative medicine products, foods, cosmetics, 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, from regulatory exclusivity considerations to arrangements with third-party distributors. Joanne’s regulatory and compliance work include:

• Determining regulatory status of novel products;
• Pre-market and post-market compliance requirements for various regulated products;
• Restrictions on advertising and product sampling, as well as legal obligations associated with the use of social media influencers or patient ambassadors to promote medical and consumer-directed products;
• State licensing schemes for prescription drug and medical device manufacturers and distributors;
• Compliance with prescription drug compounding regulations;
• Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
• Advising on or preparing clients’ written submissions to FDA requests for comments or rulemaking activities;
• FDA’s current requirements for importing and exporting regulated products; and
• Food safety and labeling advice for food, including dietary supplements and functional foods.

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.

As an FDA regulatory specialist, Joanne 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 also collaborates regularly with Mintz attorneys who negotiate royalty monetization transactions and who defend false advertising or product liability litigation brought against FDA-regulated businesses. 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.

Joanne is an editor of and frequent contributor to the firm's Health Care Viewpoints.