Drug/Device Development Changes Imminent: 21st Century Cures Act Becomes Law
Life sciences companies are navigating sweeping changes brought about by the 21st Century Cures Act (the “Cures Act” or the “Act”) signed in recent years. Of most interest to those companies is how the Act is changing the pathways and processes for developing and getting approval for new drugs and devices and new uses for existing products.
The drug and device provisions of the Cures Act are designed to accelerate the discovery, development, and delivery of life-saving therapies. While the rhetoric of the new administration has been largely confined to speeding up FDA review of approval applications, knowledgeable industry veterans are well aware that current review times are historically fast and that the real opportunities to speed innovation lie in the development and testing phases that occur prior to FDA review. The Act therefore incorporates the long-standing desire of patient advocacy groups, drug and device manufacturers, and research organizations to modernize the regulation of drug and device development and minimize barriers to innovation that occur prior to submission of an application. But don’t expect most of these changes to occur soon — the Act allows the FDA several years to implement many of the most sweeping provisions and, on top of that, the FDA has a long tradition of missing deadlines set in legislation.
ADAPTIVE CLINICAL TRIAL DESIGNS
The Act directs the FDA to issue a guidance that describes how such trials can satisfy the Federal Food, Drug, and Cosmetic Act’s requirement of a showing of “substantial evidence” of safety and effectiveness and what information about such trials that companies should provide to the FDA. The FDA must hold a public meeting and gather input from stakeholders within 18 months of enactment, and then the agency must issue guidance within 18 months of the public meeting and finalize that guidance within one year after the comment period on the guidance closes.
GREATER USE OF PATIENT EXPERIENCE DATA IN APPROVALS
USE OF REAL-WORLD EVIDENCE AND QUALIFIED DATA SUMMARIES FOR NEW INDICATIONS
The second change to new indications approval allows the FDA to rely upon “qualified data summaries” when approving supplemental applications. A qualified data summary is a summary of clinical data that demonstrates the safety and effectiveness of a drug for a “qualified indication,” which is an indication that the FDA “determines to be appropriate for summary-level review.” The Act does not require the FDA to issue guidance on the use of qualified data summaries, and this section of the law appears to take effect immediately.
PRIORITY REVIEW FOR BREAKTHROUGH DEVICES AND EASING DEVICE REGULATION
Other significant changes to device regulation include:
STREAMLINING HUMAN SUBJECT RESEARCH REGULATIONS
The Cures Act aims to speed the approval of drug-device combination products by clarifying how the “primary mode of action” of a product is to be determined and by requiring the FDA to meet with sponsors and agree early in development how best to study the combination product to meet approval standards. The Act also establishes procedures governing disagreements between sponsors and the FDA on how to treat a combination product.
In addition, the Act clarifies the FDA’s authority over genetically targeted drugs by allowing sponsors to rely on data for the same or similar technology from previously approved applications by the same sponsor.
A large number of provisions in the 21st Century Cures Act are aimed at swift approval of new drugs and devices. About $430 billion is allocated over 10 years to allow the FDA to:
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