DiscoveryThe National Institutes of Health (NIH) would be reauthorized, and funded with over $31.8 billion for fiscal year 2016, $33.3 billion in fiscal year 2017, and $34.8 billion for fiscal year 2018. This bill establishes an Innovation Fund within the NIH for medical research. This fund would receive an additional $2 billion in appropriations beyond what is given to the NIH as a whole for each fiscal year between 2016 and 2020.
The NIH would also develop a five-year strategic plan for biomedical research. Individual research centers within the NIH would use that plan for their research activities. Rare and pediatric diseases would remain a strategic priority for NIH research.
To incentivize young scientists and researchers to join the NIH, the federal government would pay $50,000 per year of student loans taken out by health professionals who are conducting qualified research.
A clinical trial registry database on eligibility for clinical trials would be established by the NIH. It would be accessible to the public in hopes of facilitating collaborative research.
This bill would also establish a Council for 21st Century Cures, which would be organized as a nonprofit unaffiliated with the U.S. government. It would focus on accelerating the development of cures, treatments, and preventive measures for patients.
The Food and Drug Administration (FDA) would develop and utilize patient experience data when assessing the risks and benefits of drug development. It would also create drug development tools to help applicants get approval, licensing, or deeper investigation of medical products when creating new treatments.
Drug developers could apply for an accelerated approval development plan after they've applied for the drug’s investigation. That said, the Secretary could require the plan to be modified or terminated if the drug is shown to be unsafe or not effective enough.
The FDA would be mandated to create an Expanded Access Policy for investigational drugs to give patients who could benefit from the drug earlier access to it. Access wouldn’t be guaranteed, but information about the policy would be publicly available. A finalized version of this policy would be settled within 12 months of this legislation’s enactment.
Patients facing life-threatening or serious infections could receive certain antibiotic drugs, as the FDA would be allowed to approve antibiotics and antifungal drugs for use in small populations of patients where there is an unmet medical need. These drugs would be labeled with the phrase ‘Limited Population’ featured prominently on the packaging.
The FDA would also be responsible for monitoring resistance to antibiotic and antifungal drugs. In order to encourage the development of new drugs of these categories, the FDA would offer additional payments through Medicare for types of these drugs that make it to the market for the first four years that the drugs are in use. There would be a cap on these payments so that they may not comprise more than 0.06807 percent of the total payments for that year.
An Advisory Committee on Immunization Practices would establish a process for reviewing and approving new vaccines. That process would be reviewed and approved by the Centers for Disease Control and Prevention (CDC). The CDC would meet with vaccine developers to help them with licensing, and context, like the demographic data of populations affected by relevant diseases.
So-called ‘breakthrough devices’ that can provide treatments which have no approved alternatives could be given priority during the review and approval process. New medical devices would also have their quality assessments conducted by third parties. Within one year, the Secretary of the FDA would make recommendations about continuing this program, and evaluate its performance.The FDA would allow adaptive trial designs for new drugs that utilize Bayesian statistical methods in research. Evidence from clinical experience could also be applied to new drug research to satisfy post-approval study requirements.
The interoperability of health information technology would be based on the secure transfer of a patient’s data, and complete access to that health data without information being blocked.
Within one year, the Centers for Medicare and Medicaid would provide a report on what types of illnesses could be diagnosed through telehealth among Medicare beneficiaries.
To promote transparency for treatment prices, estimated payment amounts for outpatient procedures would be listed on a publicly searchable database so that beneficiaries can be aware of their liability.
Programs to protect patients while preventing and reducing drug abuse would be established, including a program to protect at-risk beneficiaries.