Joshua Oyster

Enforcement and Investigations

• Regularly advises medical product manufacturers and other FDA-regulated entities regarding responses to FDA warning letters, Form 483s, and similar communications alleging noncompliance with manufacturing and quality requirements.
• Frequently counsels medical product manufacturers regarding product recall considerations, including field action strategy and communications with FDA and other regulatory authorities.
• 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.
• Performed an internal investigation of a generic drug manufacturing facility in Asia related to allegations of data integrity issues and counseled the manufacturer regarding its communications with FDA and its distribution partners.
• Advised a medical device manufacturer regarding its FDA-related compliance and reporting obligations associated with a deferred prosecution agreement.
• Conducted an internal investigation of an in vitro diagnostics manufacturer related to alleged noncompliance with FDA and CLIA requirements.
• Represented a pharmaceutical manufacturer in Lanham Act litigation alleging false advertising and unfair competition by a foreign competitor that resulted in a favorable settlement.
• Represented a medical device company in a dispute related to false advertising by a competitor, which was resolved without litigation.
• Represented a contract research organization in a breach of contract dispute with a pharmaceutical company sponsor involving alleged clinical trial misconduct.
• Advised a snack food manufacturer in connection with a product recall, including the company’s communications with FDA and strategy for resolving a related dispute with a key customer.

Regulatory Compliance and Counseling

• Regularly advises medical product manufacturers on the latest policy developments and enforcement trends relating to advertising and promotion, including scientific communications regarding off-label information and the use of social media influencers.
• 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 company’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 company.
• Supported drug manufacturer with its request to FDA to modify certain post-marketing studies required under the Pediatric Research Equity Act.
• Regularly conducts reviews of medical device and pharmaceutical manufacturers’ advertising and promotional materials.
• 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.
• Advised a specialty drug distributor and third-party logistics provider regarding its compliance obligations under the federal Drug Supply Chain Security Act.
• Represented a sterile compounding pharmacy on compliance matters associated with FDA and state regulatory issues, including inspection responses, regulatory correspondence, and new legislation.
• Advised a large hospital system on DEA and state regulatory issues related to controlled substances, including licensing and diversion reporting.

Transactional Support

• 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.
• Regularly performs FDA regulatory diligence for private equity firms acquiring manufacturers of medical products, foods, dietary supplements, cosmetics, and other FDA-regulated products.
• Frequently advises biopharmaceutical companies on regulatory and clinical considerations for collaboration, licensing, and option agreements and other strategic transactions and negotiates related quality and pharmacovigilance agreements.
• Advised private equity firms on multiple transactions involving contract drug manufacturing organizations and contract research organizations, including FDA regulatory considerations and pharmaceutical industry trends regarding outsourced services.
• Advised a private equity firm on a complex sale and carve-out of a large medical device business, including developing a global strategy for managing regulatory licenses and permits and negotiating a complex transition services agreement to address regulatory and quality-related responsibilities.
• 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.