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
- Biosimilar Developments Continue at a Rapid Pace - (Posted On Friday, April 01, 2016)
- Post-Senate Vote, Major Food Manufacturers Choose to Label Genetically Engineered Foods - (Posted On Tuesday, March 29, 2016)
- Fraudulent Dietary Supplements Highlighted in 2016 National Consumer Protection Week - (Posted On Thursday, March 17, 2016)
- Mobile Health Apps Continue to Make Headlines - (Posted On Wednesday, March 16, 2016)
- Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing - (Posted On Friday, March 11, 2016)
- Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March - (Posted On Monday, February 29, 2016)
- New GE Ingredient Labeling Bill Intensifies Food Fight in Congress - (Posted On Friday, February 26, 2016)
- Reminder – Truthful Advertising Is Not Optional - (Posted On Friday, February 12, 2016)
- Positive FDA Advisory Committee Vote for First Monoclonal Antibody Biosimilar – But Will Patent Dispute Delay Launch? - (Posted On Wednesday, February 10, 2016)
- First Monoclonal Antibody Biosimilar in U.S. Gets One Step Closer to FDA Approval - (Posted On Wednesday, February 10, 2016)