Approved by the House of Representatives last year, the 21st Century Cures Act is currently being considered by the US Senate. It seems to have been the topic of much discussion over the past couple of months, but the big question remains whether or not the Senate will take action before the presidential election in November. Many proponents of the bill worry that, if action is not taken soon, the election madness will take over and impetus will languish, leaving patients desperate for answers.
But what exactly is the 21st Century Cures Act, and what will it mean for patients, industry and healthcare providers if it is passed into law?
The act has two basic objectives. The first is to guarantee a consistent and substantial funding stream for the National Institutes of Health (NIH). The NIH is the nation’s medical research agency which funds medical research at various levels and fosters innovative scientific discoveries that ensure the nation’s capability to protect and improve health. Despite the obvious importance of the NIH, the agency’s budget has dwindled in recent years and has even fallen behind inflation in purchasing power. To counteract this, the 21st Century Cures Act proposes to extend funding for the NIH over a five-year period. The agency would receive just under $2 billion each year, totaling $8.75 billion at the end of the five years. This funding is intended to support the current NIH initiatives, and promote the agency’s overall mission to find more efficient and effective treatments for US patients.
The second objective of the act is to speed up drug approvals and treatment access for patients by streamlining the Food and Drug Administration’s (FDA) drug review process. The Act will give the FDA the ability to review alternative measures of drug efficacy, including randomized clinical trials, observational studies, direct patient experiences, and drug development tools like biomarkers, rather than having to rely solely on results from multiphase clinical trials. The hope is that by providing the FDA a range of different avenues to review and approve a drug, new treatments will be entered into the market quicker, and a more personalized approach to providing medicine will be developed.
It is easy to see why many patient advocacy groups and healthcare providers might support this effort. But some critics are arguing that, whilst improving access to treatments is an admirable goal, weakening the FDA standards for drug approvals is not the way to go about achieving it. In fact, many go as far as to claim that easing FDA scrutiny actually aligns more with industry desires than it does with improving the situation for sick patients. It helps drug manufacturers get their drugs to market quicker, leading to increased sales and revenues. But in doing so, there is less time and effort spent on ensuring that patient health and well-being is protected, leaving patients at greater risk.
For patients who are seriously sick with no viable treatment options available to them, getting access to a new drug can seem like the most important thing in the world. But does that mean patient safety should be any less of a concern? It’s definitely a complex issue, and it could be one of the main reasons that the Senate has still not made a decision about whether or not to pass the act. Needless to say, it will be interesting to see what happens over the coming weeks, as we edge closer to the election and the Senate falls under more pressure to make a decision.