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 extensive experience counseling across the full product life cycle from pre-market development to post-market compliance. He routinely helps clients respond to FDA inspections and enforcement matters, analyze difficult questions related to complex or ambiguous regulatory requirements, and assess regulatory risks associated with potential acquisitions and investments. Throughout his career, he has helped clients understand and navigate emerging policy and enforcement priorities, such as medical product promotion, digital health, data integrity and sterile compounding. Bolstered by his experience as an in-house counsel at one of the nation’s leading health and well-being companies, Josh provides strategic, practical, and timely advice on pressing regulatory issues.
- Regularly advises drug manufacturers on the latest policy developments and enforcement trends relating to advertising and promotion.
- Updated global pharmaceutical firm’s policies related to communication of scientific and medical information in light of evolving policy and enforcement landscape.
- Advised a specialty pharmaceutical manufacturer regarding compliance with FDA data integrity requirements and responding to FDA inspectional observations.
- 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 pharmaceutical company regarding its compliance obligations under an FDA consent decree.
- 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 performs FDA regulatory diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies.
- Evaluated the overall effectiveness of the FDA and health care compliance program of a global pharmaceutical firm.
- Conducted regulatory review of medical device firm’s advertising and promotional materials, taking into account FDA’s evolving policies relating to medical product 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.
- Regularly performs FDA regulatory diligence for acquisitions and investments in medical device firms on behalf of both private equity firms and strategic buyers.
- Counseled 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 the FDCA and the Clinical Laboratory Improvement Amendments (CLIA).
- 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.
- Conducted FDA regulatory due diligence on behalf of private equity firm investing in health and beauty company marketing CBD-containing cosmetics.
- 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.
- Represented a sterile compounding pharmacy on compliance matters associated with FDA and state regulatory issues, including inspection responses, regulatory correspondence, and new legislation.
- Counseled a sterile compounding pharmacy on evolving United States Pharmaceopeia standards for compounding and their relationship to FDA requirements.
- 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-authored, “Outsourcing Facilities Face Rising Drug Compounding Risks,” Law360 (September 18, 2019)
- Co-author, “How FDA is Refreshing its Recall Readiness Guidance,” Law360 (May 29, 2019)
- Co-author, “What Fed. Circ. False Ad Ruling Means For Section 337 Claims,” Law360 (May 14, 2019)
- Co-author, “FDA Draft Guidance On Medical Device Inspections Is Limited,” Law360 (May 10, 2019)
- 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)
- Presenter, “FDA Promotional Considerations for Pharmacometric Tools,” American Conference on Pharmcometrics Pre-Conference, Orlando, F.L. (October 20, 2019)
- Presenter, “Violations, Enforcement and International Issues” Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Law and Regulation, Washington, D.C. (October 2, 2019)
- Panelist, “Precision Dosing: A Focus on Solutions,” FDA Workshop: Precision Dosing: Defining the Need and Approach to Deliver Individualized Drug Dosing in the Real World Setting, Silver Spring, M.D. (August 12, 2019)
- Speaker, “Regulation of Drug Manufacturing,” Food and Drug Law Institute Introduction to Drug Law and Regulation, Washington, D.C. (November 8, 2018)
- Speaker, “Advertising & Promotion: Compliance Tips from Recent Warning and Untitled Letters,” FDANews Webinar (April 26, 2018)
- JD, with highest honors, The George Washington University Law School, 2012; Order of the Coif; associate, The George Washington University Law Review ; member, Moot Court Board; member, Mock Trial Board; member, Alternative Dispute Resolution Board
- BS (Biological Anthropology & Anatomy), magna cum laude ; with distinction, Duke University, 2008; Phi Beta Kappa