Joshua Oyster's practice focuses on a wide range of regulatory and compliance issues faced by life sciences and health care companies regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) and related laws. He has experience counseling across the full product life cycle from pre-market development to post-market compliance.
Josh originally joined the corporate department as an associate in 2012. He then served as an in-house counsel for a leading health and well-being company before returning to Ropes & Gray in May 2017.
- Performed FDA regulatory diligence for numerous IPOs of early and late-stage pharmaceutical and biotech companies.
- Advised a major pharmaceutical company on strategies for working with FDA to resolve a drug shortage stemming from alleged violations of good manufacturing practices by a contract manufacturer.
- 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.
- Counseled an over-the-counter drug firm regarding dispute with competitor over umbrella branding and proprietary naming issues.
- Evaluated the overall effectiveness of the FDA and health care compliance program of a global pharmaceutical firm.
- Regularly advise drug manufacturers on the latest FDA policy developments and enforcement trends relating to advertising and promotion.
- Supported drug manufacturer with its request to FDA to modify certain post marketing studies required under the Pediatric Research Equity Act.
- Conducted an internal investigation of in vitro diagnostics manufacturer related to alleged noncompliance with the FDCA and the Clinical Laboratory Improvement Amendments (CLIA).
- Performed FDA regulatory diligence for orthopedics firm’s acquisition of another orthopedics manufacturer with complementary product portfolio.
- 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.
- Advised a dietary supplement firm regarding labeling requirements under the Dietary Supplement Health and Education Act (DSHEA).
- Counseled a dietary supplement contract manufacturer on an adulteration issue related to ingredients provided by the dietary supplement owner.
- Conducted regulatory due diligence of multiple firms marketing herbal supplements, beauty-focused supplements, and similar products on behalf of private equity client.
- Advised a manufacturer of hair care products regarding compliance with the Poison Prevention Packaging Act and reporting requirements to the Consumer Product Safety Commission (CPSC).
- Advised a cosmetics firm regarding FDA compliance issues relating to the preparation of customized skin care products.
- Regularly advised a sterile compounding pharmacy on compliance matters associated with FDA regulatory issues, including inspection responses, regulatory correspondence, and new legislation.
- Advised a large private equity firm on FDA regulatory challenges associated with a sterile compounding pharmacy transaction, including the impact of the federal Drug Quality and Security Act.
- Performed regulatory diligence for potential securities offering by clinical laboratory performing genetic testing.
- 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.
- Co-author, “Proposed FDA Drug Software Rules Strict On Pharma Companies,” Law360 (December 10, 2018)
- Quoted, “FDA Ad and Promo Enforcement Targets Presentation of Risk Info, Pre-Approval Promotions,” Drug Industry Daily (May 1, 2018)
- Co-author, “Back to first principles: a new model for the regulation of drug promotion,” Journal of Law and the Biosciences (April 2015)
- Co-author, “POM V. Coke May Impact Many FDA-Regulated Products,” Law360 (May 8, 2014)
- Co-author, “Preclusion, Primary Jurisdiction, and Private Enforcement: The Intersection of the Lanham Act and the Federal Food, Drug, and Cosmetic Act,” Bloomberg BNA’s Pharmaceutical Law and Industry Report (April 18, 2014)
- Speaker, “Regulation of Drug Manufacturing,” Food and Drug Law Institute Introduction to Drug Law and Regulation, Washington, DC (November 8, 2018)
- Speaker, “Advertising & Promotion: Compliance Tips from Recent Warning and Untitled Letters,” FDANews Webinar (April 26, 2018)