Josh Oyster steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Among the many clients Josh counsels are leading life sciences and health care companies, as well as private equity firms and investment banks focused on investing in these sectors.
With a deep command of the subject matter—and a talent for translating complex regulations into practical, strategic advice—Josh is regularly called upon for help with a range of enforcement, regulatory compliance and transactional matters. Josh routinely helps companies navigate FDA inspections, Warning Letters, product recalls, and other compliance and enforcement matters. He is frequently tapped to analyze clients’ toughest questions related to complex or ambiguous regulatory requirements, drawing on his extensive experience with key policy and enforcement priorities, including medical product promotion, digital health, drug compounding, data integrity, CBD, and developments arising from the COVID-19 pandemic. In addition, Josh assists clients in assessing regulatory risks associated with potential acquisitions and investments in FDA-regulated entities.
What clients appreciate most about Josh is his ability to see the big picture, as he seeks to understand not only the legal issues but also a company’s business and products. With prior in-house and secondment experience at leading health care and life sciences companies, Josh can readily connect with clients’ internal teams to offer tailored and timely advice to both lawyers and non-lawyers alike.
Josh frequently writes about FDA-related “hot topics” and presents at industry conferences.
Enforcement and Investigations
- Counseled a global medical device manufacturer regarding responses to FDA inspections, field actions, and internal initiatives relating to regulatory compliance and quality.
- Advised a specialty pharmaceutical manufacturer regarding compliance with FDA data integrity requirements and responding to FDA inspections and Warning Letters.
- Counseled a pharmaceutical company regarding its compliance obligations under an FDA consent decree.
- Counseled a leading device manufacturer and drafted responses to FDA in relation to a field action for an orthopedics device.
- Conducted an internal investigation of in vitro diagnostics manufacturer related to alleged noncompliance with FDA and CLIA requirements.
- Advised in vitro diagnostics manufacturer regarding its response to an FDA Form 483 inspection report related to violations of the quality system regulation.
- Advised multiple medical device manufacturers defending government investigations into their compliance with the quality system regulation and reporting of corrections and removals under 21 C.F.R. Part 806.
Regulatory Compliance and Counseling
- Regularly advises drug manufacturers on the latest policy developments and enforcement trends relating to advertising and promotion.
- Regularly advises medical device and technology firms regarding FDA’s digital health policies, including the regulation of mobile medical applications and clinical decision support tools.
- Evaluated the overall effectiveness of the FDA and health care compliance program of a global pharmaceutical firm.
- Updated global pharmaceutical firm’s policies related to communication of scientific and medical information in light of evolving policy and enforcement landscape.
- Drafted a successful request for a priority review voucher on behalf of a biotechnology firm.
- Supported drug manufacturer with its request to FDA to modify certain post-marketing studies required under the Pediatric Research Equity Act.
- Counseled a drug manufacturer on the FDA approval pathways for new indications for the manufacturer’s drug, as well as regulatory issues under the Hatch-Waxman Act.
- Regularly conducts reviews of medical device and pharmaceutical manufacturers’ advertising and promotional materials.
- Represented a sterile compounding pharmacy on compliance matters associated with FDA and state regulatory issues, including inspection responses, regulatory correspondence, and new legislation.
- Regularly performs FDA regulatory diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies and other acquisitions and investments in FDA-regulated firms on behalf of both private equity firms and strategic buyers.
- Advised private equity firms on multiple transactions involving compounding pharmacies and provided advice regarding the impact of the federal Drug Quality and Security Act.
- Performed FDA regulatory diligence for a private equity firm investing in health and beauty company marketing CBD-containing cosmetics.
- Conducted regulatory due diligence of multiple firms marketing herbal supplements, beauty-focused supplements, and similar products on behalf of private equity client.
- Performed health care regulatory diligence for private equity firm’s acquisition of a clinical laboratory and assessed compliance risks related to fraud and abuse laws, and CLIA.