On December 13, 2016, President Obama signed the 21st Century Cures Act, which was overwhelmingly passed by the Senate and House of Representatives and is supported by both sides of aisle, pharmaceutical companies, device makers, and healthcare advocates alike. Although the bill garnered support from a variety people, there are many provisions that may cause concern from a risk management and regulatory perspective.
The bill dictates the immediate infusion of money into the NIH and clinical research. The legislation provides the NIH with $4.8 billion over 10 years for research programs, gives states $1 billion to combat the opioid crisis, and provides the FDA with $500 million in funding. However, from a risk management perspective, this bill includes many regulatory shortcuts; companies may be able to avoid conducting controlled clinical trials by claiming that need outweighs the risk for a patient. Moreover, anecdotal evidence, rather than the scientific studies, may be used to approve drugs and devices. These provisions are designed to accelerate the availability of novel medical devices and drugs to patients; however, the process through which the safety of the patient is managed is not fully understood at this time.
Another contentious provision is the creation of a standard for real-world evidence; real-world evidence is defined as data coming from sources other than traditional clinical trials. Proponents of real-world evidence and drug companies say treatments will get to patients faster and more efficiently if researchers can use data collected from sources outside of traditional clinical trials.
The push to use real-world evidence is already happening; on July 27, 2016, the FDA released a draft guidance for Industry and the Food and Drug Administration on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This guidance clarifies how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. The FDA believes that real-world data can provide vital insights into the benefits and risks of medical devices. Some of the major criticism of the Cures Act is due to the real-world evidence provision. Critics note that it is a way for drug developers to bypass randomized clinical trials. Furthermore, data collected from sources other than traditional clinical trials can be unreliable and spur the use data dredging for favorable results.
Whether you are a proponent or a critic of the 21st Century Cures Act, the medical device and drug sectors are preparing for major changes. Our clients and other medical device companies need to stay informed on this bill and its implications as it will influence commercialization strategies and clinical affairs for devices coming down the pipeline. AlvaMed is up to date on this new piece of legislation and is there to offer support to our clients on this matter.
To read the 21st Century Cures Act in its entirety:
To read the FDA Draft Guidance in its entirety: