21st Century Cures is an innovation game-changer. This legislation brings our health care infrastructure into the 21st century, delivering much needed hope for patients and their loved ones. It accelerates the cycle of discovering, developing, and delivering new cures and treatments and ensures that America remains the global leader in biomedical innovation. The bill provides a once-in-a-generation opportunity to help researchers change the way we fight disease.
CATALYZES CUTTING-EDGE RESEARCH and personalized drug development.
* Authorizes innovation prize competitions to advance biomedical science for diseases that are serious and represent a significant burden. (Section 2002)
* Establishes the Precision Medicine Initiative to help researchers develop medicines tailored to individuals, rather than one-size-fits-all treatments. (Section 2011)
* Provides opportunities for new researchers and promotes earlier research independence. (Section 2021)
* Supports high-risk, high-reward research that has the potential to transform the scientific field. (Section 2036)
* Expedites the development and review of drugs for subgroups of rare disease patients by authorizing FDA to rely on data submitted in previously approved applications involving similar gene targeting technology. (Section 3012)
* Reauthorizes the pediatric priority review voucher program incentivizing the development of drugs for rare pediatric diseases. (Section 3013)
MODERNIZES CLINICAL TRIALS and evidence development.
* Directs FDA to provide clarity to drug developers about incorporating novel clinical trial designs into drug development. (Section 3021)
* Supports the utilization of real-world evidence in regulatory decision-making. (Section 3022)
* Harmonizes various regulations protecting patients in clinical trials to avoid duplication and unnecessary delays that researchers face on a daily basis. (Section 3023)
* Authorizes FDA to rely upon qualified data summaries to support the approval of supplemental applications. (Section 3031)
* Establishes an alternative approval pathway for sorely needed antimicrobial drugs intended for limited patient populations. (Section 3042)
BRINGS FDA into the 21st century.
* Removes the silos at FDA by transitioning the agency towards a disease-centric approach. (Section 3073)
* Codifies a structured framework at FDA for the submission, review, and qualification of biomarkers that can be used to evaluate the safety and effectiveness of a product earlier in the process. (Section 3011)
* Fosters development and utilization of incredibly promising approaches to regenerative medicine. (Sections 3033 - 3036)
* Reforms the flawed combination product review process to provide certainty to manufacturers developing these complex therapies and technologies. (Section 3038)
* Provides long-overdue clarification regarding how medical product manufacturers can discuss the value of therapies and technologies with insurers and formulary committees. (Section 3037)
IMPROVES MEDICAL DEVICE REVIEW PROCESS and reduces unnecessary regulation.
* Empowers FDA to apply efficient and flexible approaches to expedite the development and review of new medical technologies like the breakthrough path for drugs that Congress made law four years ago. (Section 3051)
* Streamlines medical device and diagnostic regulations and ensures FDA uses the least burdensome approaches necessary. (Sections 3052-3059)
* Exempts certain software and personal health apps from FDA regulation. (Section 3060)
EMPOWERS PATIENTS to participate in research and development activities.
* Ensures that patients can voluntarily provide hospitals and research institutions authorization to use their personal health data for future research purposes. (Section 2063)
* Puts patients at the center of the drug development and FDA review process, requiring the FDA to routinely incorporate patient input and experiences into their regulatory decision-making. (Sections 3001-3004)
INCENTIVIZES THE DEVELOPMENT of medical countermeasures and vaccines.
* Establishes a priority review voucher program that encourages the development of drugs and vaccines to protect Americans against agents that present a national security threat, like a bioterror attack. (Section 3086)
* Provides current and potential vaccine manufacturers with more predictable CDC timeframes. (Section 3091-3093)
FOSTERS INTEROPERABLE Health Records.
* Expedites the interoperability of electronic health record systems to help make good on the $30 billion taxpayer investment and benefit patients, providers, and researchers. (Sections 4003-4006)
