Rebecca focuses her practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of regulatory and compliance issues under the Food, Drug and Cosmetics Act and related laws. Rebecca routinely provides regulatory counsel for corporate transactions, license and collaboration agreements, manufacturing and supply arrangements, and public and private securities offerings involving drug, device, cosmetic, food, and dietary supplement companies. Rebecca also regularly provides legal and strategic advice to pharmaceutical and biotech clients on advertising and promotion issues. Rebecca maintains an active pro bono practice with a focus on immigration, health care, and child welfare issues.
Transactions and Offerings
- Routinely provide regulatory counsel for corporate transactions involving drug, medical device, cosmetic, food, and dietary supplement companies. Representative transactions:
- Represented Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, in its sale to Sanofi for approximately $2.9 billion.
- Represented Pfizer in its $6.7 billion acquisition of Arena Pharmaceuticals, a biotechnology company developing potential therapies for the treatment of several immuno-inflammatory diseases.
- Represented TPG Capital and Clayton, Dubilier & Rice on regulatory matters in their acquisition of Covetrus, a global leader in animal health technology and services.
- Represented Blackstone Life Sciences in its $2 billion strategic collaboration to support Alnylam’s advancement of innovative RNA interference (RNAi) medicines.
- Represented GHO Capital Partners LLP in its investment in Biocare, a leading developer of world-class immunohistochemistry and in situ hybridization reagents for cancer diagnosis and chromosomal profiling.
- Represented Prevail Therapeutics in its sale to Eli Lilly and Company to establish a gene therapy program at Lilly anchored by Prevail’s portfolio of neuroscience therapeutics to address fatal genetic forms of neurodegenerative diseases including Parkinson’s disease and neuronopathic Gaucher disease, among other disorders.
- Represented Avista Capital Partners in its acquisition of G&W Laboratories, Inc.’s extended topicals and dermatology business unit.
- Represented Blackstone Life Sciences in its acquisition of Clarus, a leading global life sciences investment firm that closed its inaugural fund with $4.6 billion in capital commitments.
- Routinely provide FDA regulatory advice for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies. Representative matters:
- Represented Sigilon Therapeutics, Inc. in its $145 million initial public offering.
- Represented underwriters in the $82.5 million initial public offering of Codiak BioSciences, Inc., a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines.
- Represented lead underwriters in the follow-on offering of Fulcrum Therapeutics, Inc.
- Represented underwriters in several debt and equity offerings for Rhythm Pharmaceuticals, Provention Bio and Seres Therapeutics.
- Frequently advise pharmaceutical and medical device clients in connection with collaboration, licensing, manufacturing, and quality agreements.
Advertising and Promotion
- Routinely assess regulatory compliance of advertising and promotional materials for pharmaceutical, biotech, medical device, cosmetic, and food companies.
- Routinely assist pharmaceutical and medical device clients in developing policies and procedures governing the processes and standards for review, approval, and use of promotional and non-promotional materials.
- Routinely advise pharmaceutical clients on issues related to communications that are consistent with the FDA-approved labeling (CFL) and scientific exchange.
- Frequently serve as the legal and compliance reviewer on pharmaceutical and biotech clients’ promotional and medical review committees, advising on product launch, marketing strategy, digital and print promotional materials, training materials for sales representatives, medical conference presentations and materials, and social media strategy.
- Seconded for four months to global biopharmaceutical company as an associate general counsel responsible for endocrinology and fertility therapeutic areas, leading legal issues relating to advertising and promotional review committees, as well as supporting and advising brand teams and senior leadership and drafting commercial agreements, among other corporate responsibilities.
- Performed an assessment of a pharmaceutical client’s promotional review committee, which involved employee interviews, reviewing SOPs and other internal documents, evaluating a sampling of promotional materials used by the company, and providing recommendations for improvement.
- Regularly advise on policies and procedures for pharmaceutical, medical device, cosmetic, and food clients, including policies governing GxP and quality activities, internal and third party audits, vendor selection, qualification and management, complaint handling, recalls and adverse event reporting.
- Conducted an internal investigation of a pharmaceutical manufacturer related to alleged noncompliance with FDA data integrity and cGMP requirements.
- Drafted a successful request for a priority review voucher on behalf of a biotechnology firm.
- Advised a pharmaceutical client regarding recall strategy and related regulatory and customer communications.
- Advised a medical device client regarding issues related to recall and regulatory reporting decisions.
- Advised pharmaceutical clients regarding compliance with cGMP requirements and responding to FDA Form 483 inspection observations and FDA warning letters.
- Advised pharmaceutical clients on issues related to Hatch-Waxman, orphan drug exclusivity, and new chemical entity exclusivity.
- Advised a compounding pharmacy on compliance matters associated with the Drug Quality and Security Act and implementing FDA regulations and guidance.