FDA Posts Work Plan on Implementing Cures Act
FDA has released a draft work plan outlining how it will allocate $500 million over the next nine years to implement the 21st Century Cures Act. The work plan focuses on implementing Title III of the Cures Act that involves medical product development activities. It includes authorities FDA can use to help modernize drug, biological, and device product development and review, and to create greater efficiencies and predictability in product development and review. The Act is also aimed at the agency’s ability to hire and retain scientific, technical, and professional experts in positions that support product development, review, and regulation.
One top area receiving significant funding is targeted at advancing new drug therapies section, such as qualification of drug development tools. The Act requires FDA to establish a qualification process for drug development tools (e.g., biomarkers, clinical outcome assessments) for proposed contexts of use. Once a tool is qualified under this new process, “any sponsor may use it for its qualified context of use to support an application for approval or licensure of a drug or to support the investigational use of a drug,” the agency says. “Expert FDA staff and contractors will help develop evidentiary criteria needed to support qualification, develop regulatory informatics platforms, and integrate new review processes. This must occur quickly to ensure FDA can meet its obligations under this section within statutory timeframes, including developing and issuing guidance outlining procedures for the qualification process, holding public meetings, and posting public reports. Once fully implemented, this section has the potential to transform drug development and review.”
Another section under the Act that is given attention under the work plan involves grants for studying continuous manufacturing. “Continuous manufacturing has significant potential to improve the agility, flexibility, cost, and robustness in the development of manufacturing processes for both small-molecule drugs and biotechnology products,” the work plan notes. “Expert FDA staff will issue grants to enhance knowledge of novel continuous manufacturing technologies, and develop well-defined scientific standards and policies for clearly articulating how the agency will evaluate these technologies as part of regulatory submissions for new drugs, generic drugs, biotechnology products, and biosimilars.”
Additionally, significant resources will be poured into the Act’s section on patient access to therapies and information. This section covers “summary level review” that would allow FDA to rely on qualified data summaries to support approval of a supplemental application for a qualified use of a drug. “Data summaries may be used if the drug has existing safety data that is available and acceptable to FDA as part of the supplemental application and if the full data used to develop the qualified data summaries are submitted in the application,” the agency says. Under this section, FDA is required to also implement an accelerated approval program for regenerative advanced therapies and update and modernize its regulation of combination products.
And the plan expands the medical device expedited access pathway to include 510(k)-submitted devices. The agency’s “least burdensome” device review program will be enhanced under the Act to include training relevant employees on applying least burdensome principles, with outside auditing of that training.