Rebecca H. Williams
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.
- Routinely assess regulatory compliance of advertising and promotional materials for pharmaceutical, biotech, medical device, cosmetic, and food companies.
- Routinely serve as the legal and compliance reviewer on pharmaceutical and biotech clients’ promotional review committees.
- 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 supported and advised brand teams and senior leadership and drafted 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.
Transactional and Litigation Support
- Routinely provide regulatory counsel for corporate transactions involving drug, medical device, cosmetic, food, and dietary supplement companies.
- Routinely perform FDA regulatory diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies.
- Partnered with litigation teams on government investigations of pharmaceutical and device companies involving alleged FDCA violations.
- Regularly advise on policies and procedures for pharmaceutical, medical device, cosmetic, and food clients, including policies governing GxP and quality activities, product labeling and promotional activities, internal and third party audits, vendor selection, qualification and management, complaint handling, recalls and adverse event reporting.
- Frequently advise pharmaceutical and medical device clients in connection with licensing and supply agreements.
- Advised pharmaceutical clients on issues related to Hatch-Waxman, orphan drug exclusivity, and new chemical entity exclusivity.
- Advised medical device clients regarding issues related to recall and regulatory reporting decisions.
- Assisted a pharmaceutical client in responding to an FDA Warning Letter alleging current Good Manufacturing Practices violations.
- Drafted a successful request for a priority review voucher on behalf of a biotechnology firm.
- Advised a compounding pharmacy on compliance matters associated with the Drug Quality and Security Act and implementing FDA regulations and guidance.
- Co-author, “Kisor May Be A New Dawn For Challenges To FDA Actions,” Law360 (December 2, 2019)
- Co-author, “Outsourcing Facilities Face Rising Drug Compounding Risks,” Law360 (September 18, 2019)
- Co-author, “Proposed FDA Drug Software Rules Strict On Pharma Companies,” Law360 (December 10, 2018)
- Co-author, “How States, Federal Agencies Are Challenging Drug Prices,” Law360 (April 23, 2018)
- Co-author, “The Latest FDA Move To Limit Digital Health Software Regs,” Law360 (December 21, 2017)
- JD, University of Michigan Law School, 2017
- MA (Education), Brooklyn College, 2014
- BA (English and Comparative Literature), Pennsylvania State University, 2012