More than $192 million in lobbying expenses have been spent on the 21st Century Cures Act and other legislative priorities by 58 pharmaceutical companies, 24 device companies and 26 biotech companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics.
- FDA to provide guidance on how drug makers should collect data on patient experiences in an effort to improve “patient-focused drug development.”
- FDA is tasked to establish a “breakthrough device pathway” for the approval of medical devices, which will build on the existing priority review device program and to improve the medical device classification review process, among other provisions.
- FDA to identify five types of medical software that will not be regulated as medical devices, because they are considered low risk to patients.
- The director of the National Institutes of Health is now allowed to insist that grant recipients share data that is generated from their research.
- Similarly, the FDA is charged with establishing a new pathway for biomarkers and other drug development tools, which can be used to help shorten the time it takes to develop drugs, and also reduce their failure rate.
- The secretary of the Department of Health and Human Services will have two years to oversee a review of regulations and polices regarding the disclosure of financial conflicts of interest.
- The NIH director must convene a working group to develop recommendations to enhance the “rigor and reproducibility” of NIH-funded scientific research and develop or update policies within 18 months.
- An additional $4.8 billion for the NIH, chiefly for the Precision Medicine Initiative, the BRAIN Initiative, and the “moonshot” against cancer. That funding, however, must be appropriated by Congress each fiscal year.
- $1 billion designated for grants to states to supplement opioid abuse prevention and treatment activities, over the next two years, must also go through Congress.
- $3.5 billion in cuts from the Prevention and Public Health Fund and the sale of some of the Strategic Petroleum Reserve.
- The law would provide $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government’s main biomedical research organization.
- The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neuroscience and genetic medicine.
- The law would provide $1 billion in state grants over two years to address opioid abuse and addiction.
- The Cures Act would also boost funding for mental health research and treatment, with hundreds of millions of dollars authorized for dozens of existing and new programs.
- The law would push federal agencies and health providers nationwide to use electronic health records systems and to collect data to enhance research and treatment.
- The Cures Act would cut $3.5 billion — about 30 percent — from the Prevention and Public Health Fund established under Obamacare to promote prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.
- Medicaid would no longer help pay for drugs that help patients restore hair.
- The law would gives FDA an additional $500 million through 2026 and more hiring power.