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| Office of New Drugs | |
|---|---|
| Name | Office of New Drugs |
| Formed | 1966 |
| Jurisdiction | United States |
| Headquarters | White Oak, Maryland |
| Parent agency | Food and Drug Administration |
Office of New Drugs The Office of New Drugs is a central component of the Food and Drug Administration responsible for the evaluation, review, and regulation of human drug products, including new molecular entities, biologics, and combination products. It operates within the Center for Drug Evaluation and Research and interacts with numerous agencies and stakeholders such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Department of Health and Human Services. Historically linked to major legislative milestones like the Federal Food, Drug, and Cosmetic Act and the Drug Price Competition and Patent Term Restoration Act of 1984, the office shapes policy affecting pharmaceutical companies, academic research centers, and patient advocacy organizations.
The Office of New Drugs emerged as a distinct review entity amid reforms following the 1962 amendments to the Federal Food, Drug, and Cosmetic Act and the influence of actors such as Frances Oldham Kelsey and institutions like the National Academy of Sciences. Its development paralleled regulatory responses to crises exemplified by the Thalidomide tragedy and actions by the U.S. Congress leading to expanded drug approval standards. Over decades, it adapted to innovations from firms such as Pfizer, Merck & Co., Johnson & Johnson, and research from universities like Harvard University and Johns Hopkins University. Structural changes reflected initiatives led by FDA Commissioners including David Kessler, Margaret Hamburg, and Scott Gottlieb, and were influenced by advisory committees like the Oncologic Drugs Advisory Committee and events such as the passage of the Food and Drug Administration Amendments Act of 2007.
The office’s mission encompasses review of investigational new drug applications and new drug applications, oversight of postmarketing safety requirements, and coordination with external partners including the World Health Organization, European Medicines Agency, and the Pharmaceutical Research and Manufacturers of America. It provides guidance impacting clinical trial sponsors such as GlaxoSmithKline and AstraZeneca, collaborates with payers like Centers for Medicare & Medicaid Services, and supports public health responses involving agencies like the Biomedical Advanced Research and Development Authority and the Defense Advanced Research Projects Agency. Statutory responsibilities tie to laws such as the Biologics Price Competition and Innovation Act and regulatory frameworks used by courts including the United States Court of Appeals for the D.C. Circuit.
Within the Center for Drug Evaluation and Research, the office comprises multidisciplinary review divisions that mirror therapeutic areas represented in academic centers like Mayo Clinic and research consortia such as the National Cancer Institute. Leadership roles have been held by directors appointed under secretaries of Department of Health and Human Services, and the office interacts with fields represented by institutions such as Massachusetts Institute of Technology and University of California, San Francisco. Committees include clinical pharmacology reviewers, biostatistics teams, and regulatory project managers who coordinate with agencies such as the Office of Management and Budget and standards organizations like the International Council for Harmonisation.
The review process begins with an Investigational New Drug submission, progresses through phases of clinical trials overseen by institutional review boards at places like Mayo Clinic Hospital and follows protocols developed in collaboration with sponsors such as Eli Lilly and Company and Bristol-Myers Squibb. New Drug Applications and Biologics License Applications are evaluated using statistical analyses from biostatisticians trained at institutions like Stanford University and Columbia University, with advisory input from panels including the Vaccines and Related Biological Products Advisory Committee. Postapproval surveillance leverages systems such as the FDA Adverse Event Reporting System and collaborations with public health entities like State Health Departments and the National Institutes of Health Clinical Center.
The office issues guidance documents that draw on international standards from the European Medicines Agency and the World Health Organization and reflect statutes including the 21st Century Cures Act. Policy development has responded to scientific advancements from laboratories at Salk Institute and Broad Institute, and public input from organizations like the PatientsLikeMe community and advocacy groups such as the American Cancer Society. Policies address expedited pathways like breakthrough therapy designation influenced by legislation and executive actions involving the White House and congressional committees like the Senate Committee on Health, Education, Labor, and Pensions.
Major programs include expedited review pathways used for therapeutics developed by companies such as Moderna and Regeneron Pharmaceuticals, pediatric exclusivity programs tied to acts championed by members of U.S. Congress, and risk evaluation and mitigation strategies coordinated with stakeholders like the Substance Abuse and Mental Health Services Administration. Initiatives have targeted orphan drugs influenced by advocacy from groups like the National Organization for Rare Disorders and global health collaborations involving Gavi, the Vaccine Alliance and the Bill & Melinda Gates Foundation. The office also engages in pharmacovigilance modernization in partnership with technology firms and research centers including Carnegie Mellon University and University of Pennsylvania.
The office has faced scrutiny over high-profile approvals and rejections involving products from firms such as Insys Therapeutics and Valeant Pharmaceuticals International, and debates over drug pricing tied to corporations like Turing Pharmaceuticals. Critics including academics from Yale University and policymakers in the U.S. Senate have questioned transparency and postmarket surveillance capacity during events like the opioid crisis associated with companies such as Purdue Pharma. Legal challenges have arisen in courts including the United States Supreme Court and the U.S. Court of Appeals for the Federal Circuit, while public interest groups like Public Citizen and media outlets including The New York Times and ProPublica have investigated approval processes and advisory committee interactions.