Joanne S. Hawana
- Represented a diagnostic developer during an FDA investigation into its alleged distribution of an unauthorized test for COVID-19 and subsequent recall activities.
- Supported Mintz Corporate Team in negotiating and executing the sale of a client’s FDA Priority Review Voucher to another party for over $100 million.
- Negotiated the release of consumer goods by FDA on behalf of a retailer client following the agency’s erroneous conclusion that the shipments contained laser components that did not comply with U.S. law, thereby leading to their detention at the port of entry.
- Counseled a nationally recognized health system regarding the construction of advertising claims for various services involving regenerative medicine-based therapeutic procedures.
- Served as FDA specialist and regulatory team leader on a client’s complex bid for a bankrupt pharmaceutical company’s U.S. and European drug-related assets, including marketing authorizations and distribution permits.
- Handled regulatory due diligence and related contractual negotiations for two acquisitions of independent testing laboratories by a global client.
- 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 secured Emergency Use Authorizations from FDA that allowed 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.
- Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the compliance obligations associated with this form of compounding business, including with respect to applicable COVID-19 enforcement discretion policies.
- Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products was detained by Customs and Border Protection due to non-compliant labeling and assisted company in developing plans for reconditioning the products.
- Counseled a cosmetic company on its response to an FDA Warning Letter related to the use of drug claims to promote cosmetic products and then assisted in the company’s implementation of internal processes and procedures to avoid similar issues in the future.
- Represented an innovative beverage company with a national profile on FDA compliance issues, labeling, promotional activities, and distribution agreements.
Case Study
When Daré Bioscience Operations, Inc. first became a Mintz client, it was a private health care company working to develop innovative product candidates in women’s reproductive health. Due to the significant expenses associated with product development and regulatory compliance for innovative drug, device, and combination products, the San Diego-based company sought to raise capital through entering the public markets. Since becoming a public company, Daré Bioscience has in-licensed multiple exciting product candidates focused on women’s sexual health, vaginal health, fertility, and contraception and prioritized a goal of achieving FDA marketing approval for one or more products.
Case Study
Mintz advised Glia, LLC on its successful bid to obtain orphan drug status from the FDA for its topical gel to treat ocular Graft-versus-Host Disease. The disease can affect stem cell or bone marrow transplant recipients and cause intense eye pain, ocular degeneration, and blindness.
Case Study
Mintz represented Massachusetts General Hospital and Partners HealthCare in a deal that enables them to monetize part of their royalty interests in Entyvio, an antibody used to treat digestive diseases, to invest in research. Royalty Pharma paid $94 million in the true sale roll-up transaction.
Case Study
Mintz represents a company developing new drug therapies to treat neurodegenerative diseases and developmental disorders. Mintz advises the company on FDA issues, presentations to the company's board, and publication and presentation of the data.
Case Study
Mintz represents a major Boston-based health care system that includes academic medical centers, community hospitals, physician practices, and a managed care plan. Mintz attorneys helped the system establish a specialty pharmacy and developed new provider contract templates for the health plan.