The 21st Century Cures Act & What It Means for Health & Medical Research
So seldom does legislation attract broad bipartisan support in Congress that when it actually happens suspicion is that the bill must be either innocuous or the proverbial pork barrel from which most members of both the House and the Senate may partake. Passage of the 21st Century Cures Act falls into the latter category.
But what does the Cures Act actually mean for health and medical research? After all, the bulk of the Act’s funding – $3.5 billion of $6.3 billion over five years– is made up of dollars taken from the Prevention and Public Health Fund that was a critical part of Obamacare, the Affordable Act Care. Moreover, some of the research funding is subject to annual appropriations and the uncertainty surrounding a Trump Administration’s budgetary priorities makes the availability of funding suspect.
What is clear about Cures are the areas legislators and President Obama agreed on as important:
1) addressing the opioid and prescription pain drug epidemic
2) accelerating the identification and testing of promising cancer tools
3) neurological research, with special emphasis on Alzheimer’s disease
4) “personalized” or individualized medicine by which better matching is achieved between a patient’s illness and treatment by making use of genomic research and biomarkers
5) mental health policies that address better suicide prevention and expand the types of mental illnesses to be treated
Woven into these substantive areas is the Act’s insistence that medical progress and health-care improvement can be accelerated by expediting the review and approval process by which the Food & Drug Administration considers new drugs and devices. To accomplish this, Congress directed that the FDA consider standards other than and in addition to the traditional and generally-acknowledged to be more rigorous randomized clinical trials.
Additional emphases include supporting young scientists and researchers and rewarding innovation that promotes better patient outcomes.
Taken all in all, the Cures Act is meant to prompt more attention to and engagement with the following areas of research:
§ cancer and the potential of immunotherapy
§ genetic medicine
§ pediatric medicine
§ mental health, including eating disorders
Some of these (e.g., cancer) are perennial areas of research in which recent advances in diagnosis and treatment hold extraordinary promise, while others are more recently arrived. Still others such as mental health have not enjoyed robust funding but may now attract more attention by dint of increased availability of research support. Still others – most conspicuously, opioid addiction – are only now garnering attention as the disease manifests itself throughout the country.