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Why Patients Need Congress To Reauthorize PDUFA

The Prescription Drug User Fee Act (PDUFA) provides vital resources to the FDA for promptly reviewing the safety and effectiveness of new drugs and making them available to patients. Initially signed in 1992, the law is reauthorized every five years, often with improvements to the review process for new, potentially life-saving medicines.

Congress must vote to reauthorize PDUFA before it expires this September. The revised PDUFA VII can improve the review process for new drugs.

PDUFA VII would support Pfizer’s commitment to modernizing the drug development process to make sure that drugs are thoroughly reviewed while ensuring new safe and effective treatments are available for patients. By enhancing FDA’s capacity to review innovative treatments, the updated PDUFA would help biopharma companies and regulators become stronger, more efficient, and more patient-centric to advance and deliver tomorrow’s scientific breakthroughs.

Three Ways PDUFA VII Will Support Innovation and Access to Cures

1. Promote innovation and scientific dialogue. The FDA anticipates a wave of gene therapy and advanced biologic submissions for review in the coming years, which threatens to overwhelm the review processes. Unless Congress provides support for reviewing a growing number of gene therapies and biologics, the FDA backlog may set back the field, delay application review, and limit patients’ access to potential cures for serious diseases. PDUFA VII will increase dedicated resources to quickly hire scientists and medical specialists to review cell and gene therapy submissions while keeping pace with rapidly evolving scientific standards.

2. Modernize regulatory reviews. Real-world data generated through the delivery of routine healthcare, including electronic medical records, administrative claims data, and patient-generated data, can provide powerful insights and evidence to inform regulations on the safety, efficacy, and optimal use of innovative medicines. The updated PDUFA will accelerate the use of real-world evidence for transparent and methodologically sound regulatory decision-making.

3. Advance digital health technologies. PDUFA VII captures many of the durable lessons learned from the COVID-19 pandemic, including digitally enabled, decentralized trials to reduce barriers to patient care via telemedicine; wearable technologies and mobile apps; electronic consent; and remote patient monitoring.

The FDA is committed to establishing a new framework for digital health technologies, with a focus on clarifying regulatory validation processes for digital products and end points and artificial intelligence algorithms.

Did You Know? PDUFA by the Numbers

  • In 2020, the FDA approved nearly 60 innovative new drugs and biologics, many for areas of high unmet medical needs.
  • PDUFA funding supports 4,350 FDA medical reviewers, scientists, and other staff members who are relying on Congress to reauthorize the user fee law by October 1, 2022.