Regulatory Strategy, Product Development & Product Approvals

FDA Regulatory
Command of FDA regulatory matters and associated issues in patent and antitrust law is critical when seeking product approvals, developing an effective lifecycle management strategy, and preparing for market entry. Ropes & Gray provides clients the strategic and legal advice needed to succeed.

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“This highly regarded firm is considered a significant force due to its broad regulatory expertise which includes advising clients on litigation, transactional and policy matters. Its deep FDA capabilities informed significant First Amendment litigation regarding off-label promotions, and its health care group has worked extensively on matters involving the impact of the Affordable Care Act.” Chambers USA

Overview

Research and Development

We work closely with our clients from the earliest stage of a product’s life cycle – research and development. Our firm’s work representing academic medical centers, research institutes and universities, in addition to global life sciences companies, gives us a wide range of experience and perspective from which to draw when counseling clients on clinical research and development activities. We regularly counsel FDA-regulated companies that sponsor product research on compliance with federal laws relating to clinical research, including FDA investigational new drug and investigational device exemption requirements, human subjects protections, adverse event reporting, clinical trial registration and results reporting, privacy laws, conflicts of interest, and the proper use of federal research funds. We help clinical sites and research sponsors develop and implement research policies, procedures and templates to ensure compliance with legal requirements, protect business interests and facilitate research activities.

Product Approvals

Obtaining FDA approval or clearance to market drugs, biologics, medical devices and food additives – especially those that have encountered difficulties in the approval process – requires experienced counsel. We regularly advise clients on such matters, from the initial development of regulatory approval strategies through implementation of those strategies, including preparing for and participating in advisory committee proceedings, responding to difficult questions from the FDA and appealing adverse decisions.

Competitor Market Entry

Strategic business and legal advice is essential on statutory provisions that confer exclusive marketing rights on qualifying products, including the Hatch-Waxman Act, the Orphan Drug Act, the pediatric exclusivity provisions of the Federal Food, Drug & Cosmetic Act, and the Biologics Price Competition and Innovation Act. We are one of the few firms that combines a top-ranked FDA counseling practice with highly regarded IP rights management and IP litigation practices. This combination of skills and experience gives us an unsurpassed understanding of the relationship between patent and nonpatent exclusivity rights.

Experience

Examples of our product development, product approvals & market access, and competitor market entry representations include:

Research and Development

  • We advised two leading pharmaceutical manufacturers in response to FDA Warning Letters relating to Good Clinical Practices (GCP) noncompliance; our work included investigating the allegations of noncompliance and developing effective remedial actions.
  • One of our partners represented a clinical investigator in disqualification hearings before the FDA involving alleged violations of GCP requirements.
  • Conducted an internal investigation of a pharmaceutical company’s development program for its lead compound to evaluate allegations that the company ignored safety signals from primate studies, mischaracterized human adverse events and delayed reporting others, and compromised patient safety by continuing trials in light of the data. 
  • Drafted policies to govern the registration of clinical trials and reporting of results pursuant to FDAAA.
  • Assisted a multinational pharmaceutical company in an audit of FDAAA compliance.

Product Approvals 

  • Advised a pharmaceutical company with respect to regulatory and public disclosure matters relating to a pending drug application with the FDA.
  • Advised a biopharmaceutical company during the FDA approval process for its first drug to be marketed in the United States, including issues related to FDA approval concerns, development of an initial sales and marketing compliance program, clinical trial matters, and distribution/reimbursement concerns.
  • Represented one of the world’s largest biotech companies in gaining early FDA approval for a drug that represented a major improvement over existing products, despite the strenuous opposition of a competitor.
  • Helped obtain FDA approval through very challenging regulatory proceedings for two of the most significant food additives, Olestra and Splenda, approved by the FDA in recent years.
  • Represented a drug company in addressing pharmacy compounding of its orphan drug product.

Competitor Market Entry 

  • Successfully argued that proposed generic drug products should not be permitted to circumvent the innovator’s exclusivity rights by "carving up" the approved labeling in a manner that made the drug less safe to use.
  • Prepared several submissions to the FDA and other U.S. federal agencies to assist a global pharmaceutical company in executing a variety of business and legal initiatives to maximize its patent and nonpatent exclusivity rights for an important oncology drug.
  • Aided a client in understanding how the Hatch-Waxman rules on preapproval litigation of patent disputes with potential generic drug manufacturers can be used to protect intellectual property.
  • Frequently presented scientific data and legal arguments to the FDA demonstrating the differences between innovator and potential generic or follow-on products.
  • Represented several innovator companies in crafting the new federal law creating an approval pathway for “biosimilar” products, helping to ensure that the legislation retained sufficient incentives for innovation.
  • Advised a biopharmaceutical company on the Hatch-Waxman Act and the Orange Book listing of method of use patents.
  • Advised a leading global pharmaceutical company in connection with Hatch-Waxman exclusivity concerning antibiotics.