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| Priority Review | |
|---|---|
| Name | Priority Review |
| Type | Regulatory designation |
| Introduced | 1992 |
| Jurisdiction | United States |
| Administered by | Food and Drug Administration |
| Purpose | Accelerate evaluation of important therapeutics |
Priority Review
Priority Review is an expedited regulatory designation used to accelerate the evaluation timeline for submissions of therapeutics by national regulatory authorities. Originating in the United States under amendments to the Food, Drug, and Cosmetic Act, the pathway aims to shorten decision times for products addressing unmet medical needs. It complements other mechanisms such as Breakthrough Therapy designation, Fast Track designation, and Accelerated Approval to facilitate earlier patient access to important medicines.
Priority Review was established to reduce the standard review period for regulatory applications to a target goal, enabling quicker regulatory action by agencies such as the Food and Drug Administration and analogues in other jurisdictions. Implementation interacts with statutes like the Prescription Drug User Fee Act and policy frameworks developed by agencies including the European Medicines Agency and regulatory bodies in countries such as Japan and Canada. Historically, Priority Review has been invoked for therapeutics associated with high-impact conditions treated in contexts like the HIV/AIDS epidemic, the Ebola virus epidemic in West Africa, and public health emergencies recognized by the World Health Organization.
Eligibility criteria typically require evidence that a product may provide a significant improvement in safety or effectiveness for serious or life-threatening conditions such as cystic fibrosis, pancreatic cancer, or Alzheimer's disease. Agencies compare proposed benefits against available therapies including established treatments like insulin for diabetes mellitus or trastuzumab for breast cancer. Legislation and guidances reference statutory constructs like those found in the Food, Drug, and Cosmetic Act and policy instruments shaped by stakeholders including the Pharmaceutical Research and Manufacturers of America and patient advocacy groups such as American Cancer Society and AIDS Coalition to Unleash Power.
Sponsors submit requests as part of marketing applications such as a New Drug Application or a Biologics License Application in the United States. The process involves interaction with review divisions like the Center for Drug Evaluation and Research and advisory committees including panels convened under statutes similar to those governing the Advisory Committee on Immunization Practices. Timelines are compressed relative to standard review targets influenced by fee structures under the Prescription Drug User Fee Act and operational practices observed at agencies like the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency. Review activities include benefit–risk assessment, inspections of manufacturing sites registered with authorities comparable to the Centers for Disease Control and Prevention oversight in public health contexts, and consideration of postmarket commitments exemplified by requirements seen in approvals for therapies addressing rare diseases.
Priority Review can materially change development strategy for sponsors such as major firms like Pfizer, Roche, Novartis, and smaller biotechnology companies that emerged from institutions like Massachusetts Institute of Technology spin-offs. The designation affects licensing negotiations involving partners such as GlaxoSmithKline and Johnson & Johnson, and influences investment decisions by venture firms reminiscent of Sequoia Capital and OrbiMed Advisors. Outcomes include earlier market entry for therapies treating conditions exemplified by hepatitis C or multiple sclerosis, alterations in clinical trial design similar to ones used in multicenter trials at institutions like Mayo Clinic and Johns Hopkins Hospital, and implications for reimbursement discussions with payers including entities modeled on Centers for Medicare & Medicaid Services.
Regulatory authorities in regions such as the European Union, Japan, Canada, Australia, and emerging regulators in Brazil and India have adopted analogous accelerated pathways with varying criteria and timelines. The European Medicines Agency operates procedures like accelerated assessment that mirror aspects of Priority Review and interacts with frameworks developed under agreements such as those between the European Commission and national competent authorities. Japan’s Pharmaceuticals and Medical Devices Agency and Canada’s Health Canada have implemented comparable mechanisms influenced by global harmonization efforts led by organizations including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Critiques center on concerns articulated by academics at institutions like Harvard University, Stanford University, and University of Oxford regarding evidentiary thresholds, post-approval surveillance, and potential trade-offs between speed and certainty. High-profile disputes have arisen over approvals involving products from companies such as Theranos-adjacent controversies (as illustrative of diagnostic claims) and contentious oncology approvals debated at advisory meetings similar to those convened by the Food and Drug Administration's committees. Policy analyses from think tanks like the Brookings Institution and RAND Corporation highlight debates over transparency, real-world evidence generation, and alignment with health technology assessment bodies such as the National Institute for Health and Care Excellence.
Category:Regulatory affairs