Sarah Blankstein is counsel in Ropes & Gray’s life sciences regulatory and compliance practice. Sarah provides legal and strategic advice to pharmaceutical, biotechnology and medical device companies on a wide array of FDA regulatory matters, with a focus on promotional and post-approval compliance, regulation of digital health tools, product development, and lifecycle management. Sarah also provides regulatory counsel for transactions as well as complex internal investigations and government enforcement matters involving FDA-regulated companies.
Sarah rejoined Ropes & Gray in 2018 from Vertex Pharmaceuticals, where she served as commercial and regulatory legal counsel.
- Routinely review promotional materials for pharmaceutical and medical device companies for both FDA and FTC compliance.
- Developed policies, procedures and trainings for multiple clients addressing promotional and non-promotional communications and activities.
- Regularly counsel life sciences companies in competitive disputes involving product communications.
- Conducted a comprehensive risk assessment of a large pharmaceutical company’s speaker programs.
- Advised a medical device company in its response to an FTC investigation of the company’s promotional practices, resulting in a public closing letter.
- Routinely provide strategic advice and analysis to healthcare provider, pharmaceutical, biotechnology, and medical device clients on evolving FDA regulatory framework for software products and artificial intelligence technologies.
- Developed policies, procedures, trainings and tools for healthcare industry clients to address internally-developed digital tools.
- Counseled large electronic health records company on compliance with software quality standards, development of quality-related policies and procedures, and analysis of FDA regulatory framework applicable to development of clinical decision support tools.
Product Development and Lifecycle Management
- Routinely advise life sciences industry clients on good clinical practices and IND/IDE-related requirements.
- Advised a biotechnology company throughout the BLA process, including in connection with eligibility for priority review, the advisory committee process, and dispute resolution mechanisms.
- Regularly advise clients on Hatch-Waxman issues related to patents, including eligibility of patents for Orange Book listing, completion of FDA Form 3542 and development of “use codes,” and considerations related to patent certifications, Section viii carve-outs, and patent listing disputes.
- Drafted successful request for a rare pediatric disease priority review voucher on behalf of a pharmaceutical client.
- Provided strategic advice to a large pharmaceutical company seeking to amend a pediatric written request (PWR) to obtain pediatric exclusivity.
- Counseled a medical device company on regulatory approval strategy for an over-the-counter device, including assisting with preparation for and participating in a formal pre-submission meeting with the FDA review division.
Transactional and Litigation Support
- Routinely perform regulatory diligence and negotiated key regulatory deal terms in numerous corporate transactions involving pharmaceutical and medical device companies.
- Partnered with litigation teams on government investigations of pharmaceutical and device companies involving alleged FDCA violations.
- Assisted a medical device company with a large internal investigation related to recall and regulatory reporting decisions.
- Advised pharmaceutical company in connection with investigation of data integrity allegations involving preclinical studies for a pipeline product.
- Conducted a comprehensive assessment of a major pharmaceutical company’s clinical trial data sharing policies to support compliance with the PhRMA/EFPIA joint Principles for Responsible Clinical Trial Data Sharing.
- Drafted and reviewed policies and procedures for a range of life sciences industry clients, including policies governing promotional activities and interactions with healthcare providers, scientific communications, clinical trials, grants and sponsorships, investigator initiated research, sampling, GxP and quality activities, and adverse event reporting.
- Advised pharmaceutical manufacturers, medical device companies, and compounding pharmacies during regulatory inspections and in responding to FDA 483s.
- Advised a pharmaceutical company in connection with REMS modifications and implementation.
- Counseled a biotechnology company on a range of issues related to clinical trial transparency, including clinicaltrials.gov requirements, clinical trial data sharing, and lay summaries.