Life Sciences Regulatory & Compliance

We advise on pre-market strategy and implementation, including in areas such as:

• Product development
• Clinical investigations
• Expedited review and approval pathways
• Orphan drug and other designations
• Pre-market applications (e.g., NDAs, 505(b)(2)s, ANDAs, BLAs, biosimilars applications, 510(k)s, de novo requests, and PMAs)
• Dispute resolution and appeals
• Label negotiations
• Commercial launch preparation
• Inspection readiness
• Assessment of exclusivity protections

We advise on a full spectrum of post-market issues, including those related to:

• Labeling
• Advertising and promotion
• Adverse event reporting
• Product recalls
• Good manufacturing practices 
• Agency inspections and remediation of inspection findings
• Responding to agency enforcement actions, including warning and untitled letters
• Patent term extension

We lead internal investigations of regulatory and compliance matters, including those involving allegations of misconduct or wrongdoing raised through confidential reporting hotlines or traditional methods, as well as those that develop into qui tam or whistleblower matters. Our lawyers have led and conducted internal investigations into matters related to sales and marketing practices, interactions with customers and healthcare providers, reimbursement and patient support programs, diagnostic and laboratory billing requirements, and clinical trial data integrity, and many other issues. We also conduct internal regulatory and compliance risk assessments and third-party audits, including audits of physician-industry transparency (Sunshine Act) data, customer interactions, and discounting and rebate practices.

We work with pharmaceutical, biologics, medical technology, diagnostics, laboratory testing, and digital health companies on a host of market access issues, including:

• Addressing critical coverage and reimbursement requirements
• Operating patient support programs
• Negotiating payor agreements
• Handling agreements with pharmacy benefit managers and GPOs

This includes addressing federal and state regulatory requirements as they relate to clients’ medical products. See our Inflation Reduction Act & Medicare Pricing for Drugs and Biologics Resource Page for more details.

Our team includes experienced practitioners who have spent years building and operating global compliance and risk management programs from within at life sciences companies. Drawing on this experience, we help clients build programs that incorporate all the “elements of an effective compliance program” as well as the latest best practices. This involves:

• Drafting policies
• Preparing and conducting training
• Advising on day-to-day business activities
• Addressing industry transparency requirements (e.g., US Physician Payments Sunshine Act and related state laws)

We help clients ensure their commercial contracts and other customer relationships comply with the federal and state healthcare fraud and abuse laws, such as the Anti-Kickback Statute.

Please check out our Late Stage Drug Development Commercialization Roadmap.