Overview
Ropes & Gray’s life sciences regulatory and compliance team advises many of the world’s leading multinational pharmaceutical manufacturers, as well as mid-sized and emerging drug companies, in navigating FDA requirements across the full product life cycle. Knowledge of FDA regulations is critical when developing an initial regulatory strategy, seeking product approvals, developing an effective lifecycle management strategy, and assuring that products are manufactured and marketed in compliance with applicable requirements.
We routinely advise established and development-stage pharmaceutical clients on legal and regulatory matters relating to nonclinical and clinical trials; expedited development and review programs; product approvals, including Rx-to-OTC switches; negotiating and implementing risk evaluation and mitigation strategies (REMS); advisory committee meeting preparation, and appeals from adverse approval decisions; data and marketing exclusivity, including Hatch-Waxman and Orphan Drug issues; advertising and promotion; pharmacovigilance; drug safety and risk management; current Good Manufacturing Practices (cGMPs); FDA inspections; recalls; FDA Warning Letters; and other enforcement actions.
We have deep experience advising pharmaceutical clients on the full range of FDA's expedited pathways that can significantly accelerate the path from bench to bedside, including Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review. Our team helps clients evaluate eligibility, prepare designation requests, and develop regulatory strategies that maximize the benefits these programs offer throughout development and the approval process. We also advise clients on voucher programs established to incentivize the development of treatments for underserved patient populations, including the Rare Pediatric Disease Priority Review Voucher program. We assist clients in assessing eligibility for these voucher programs, structuring transactions involving the sale or transfer of vouchers, and navigating the regulatory requirements associated with their redemption.
We frequently represent pharmaceutical companies in disputes with the FDA and each other involving FDA regulatory matters and assist companies in conducting internal investigations of possible violations of FDA rules. We also advise companies on the policies, procedures, training, and other compliance measures that can help mitigate or avoid the risk of violating FDA requirements.
Experience
Representative matters include:
- Counseling on regulatory incentives for drug development and approval, including assessing eligibility for various FDA regulatory designations (e.g., orphan, breakthrough therapy, rare pediatric disease) and drafting designation requests to the FDA.
- Advising biopharmaceutical companies during the product approval process, including on FDA approval concerns, development of sales and marketing compliance programs, clinical trial matters, and distribution and reimbursement considerations.
- Counseling multinational pharmaceutical companies on issues involving the sale of over-the-counter (OTC) drug products and switching prescription pharmaceuticals to OTC status.
- Providing advice on the Hatch-Waxman Act, including the appropriateness of listing patents in the FDA Orange Book in connection with a company’s ongoing patent litigation.
- Assisting pharmaceutical companies in preparing submissions, including citizen petitions, to the FDA on issues surrounding bioequivalence of generic versions of products including assisting in the development of comments on regulatory requirements governing bioequivalence of other products.
- Assisting in the development of client policies related to activities of medical science liaisons as well as interactions of sales and marketing personnel with health care professionals.
- Representing pharmaceutical companies in internal investigations involving allegations of noncompliance with FDA requirements, including off-label promotion, fraud and abuse violations, manufacturing violations, and failure to comply with internal company policies.
- Investigating alleged Good Manufacturing Practices (GMP) violations at pharmaceutical manufacturer’s overseas plants and drafting responses to FDA that avoid the imposition of import alerts or other enforcement action.
- Providing regulatory counseling in connection with Paragraph IV certification litigation initiated by pharmaceutical company clients against generic manufacturers seeking to market products before patent expiration.
