One of the most frustrating things patients face is the absurd length of time and red tape to get medications approved for use. The FDA has been chronically understaffed and inefficient, bogged down and arguably over-cautious in cases of terminal illness. A new law aims to correct as much of this as possible.
The 21st Century Cures Act is a bipartisan $6.3 billion bill that was passed by the House on December 1st and the Senate on December 13th. President Obama has been very vocal in his support for the bill, specifically for the “Moonshot” cancer research portion in memory of Vice President Joe Biden’s son. He signed the bill into law on the 13th.
There are numerous provisions to the 21st Century Cures Act, including a few that have not yet received much attention.
The major part of the bill is $4.8 billion in ten years at the premiere National Institutes of Health for the following:
- $1.8 billion for the cancer research “moonshot” championed by Vice President Joe Biden.
- $1.56 billion for the BRAIN Initiative, a project to create new technologies that will allow for comprehensive mapping of the human brain.
- $1.4 billion for the Precision Medicine Initiative, a project supported by Obama to collect genetic data on one million American volunteers that will be used to help develop new treatments. (CBS News)
Other important issues addressed in the bill are:
- $1 billion to address prescription drug abuse at the state level
- Addition of positions at the U.S. Department of Health and Human Services to coordinate mental health and drug abuse research and treatment
- Multiple provisions that allow the FDA to speed up approval of new drugs and medical devices
- Invests in BRAIN initiative to combat diseases like Alzheimer’s
- The Bringing Postpartum Depression Out of the Shadows Act provides $5 million per year from 2018 to 2022 for states to develop screening and treatment programs for mothers (Smithsonian)
Forbes reports on an addition to the new law, one that will help small businesses with fewer than fifty full-time employees.
Title 18 of the new law, originally a separate bill called the Small Business Healthcare Relief Act, allows companies to use Health Reimbursement Arrangements to compensate employees who buy their own insurance. And it may be a present as well to advocates hoping to preserve the Affordable Care Act…[The employer] can reimburse employees’ for purchasing individual health insurance as if it were directly paying the premiums on a group health policy: the employee won’t have to pay taxes on the company’s premium contribution, and the company won’t owe payroll taxes on it, either.
As with every piece of legislation, there are winners and losers. This one is no exception. Some of the concerns include a $3.5 billion cut to the Prevention and Public Health Fund; consumer safety advocates, who are concerned drugs and devices may hit the market too soon, and the legislation does not address rising prescription drug costs; Medicaid patients will no longer receive drug payment assistance for hair regrowth treatment (i.e. Alopecia); and the FDA will not receive enough additional funds to cover their increased workload. (NPR)
Unfortunately for the rare disease community, the OPEN ACT, which would have given companies incentives to repurpose already existing medications for rare disease indications, was dropped. However, with one in ten persons suffering a rare disease, and 95% of those diseases not having a single FDA approved treatment, this group will not give up on getting this legislation passed.
Despite some inadequacies, overall the 21st Century Cures Act appears to be a net positive for patients. It promotes innovation, technology, accelerated approval processes in extreme circumstances, and mandates standards of care all to further the safety and well-being of patients.
And if nothing else, it proves bipartisanship can still occur.