The 21st Century Cures Act has rapidly risen in notoriety after receiving unanimous support from the House Energy & Commerce Committee earlier this month. Awaiting a vote from the entire House of Representatives, the bill is tied to funding for both the FDA and NIH and covers topics such as changes to the approval process for drugs and devices, interoperability and telemedicine. This first of two posts will outline the significant changes proposed by the bill for drug and device approval, with the next focusing on interoperability and telemedicine.
Streamlined Process for Drug Review
Most notably, the 21st Century Cures Act looks to streamline the FDA’s review process of drugs for additional indications by incorporating patient experience and “real-world evidence” into the decision making process. The FDA will be also be required to develop more surrogate endpoints to allow shorter clinical trials, making drugs available sooner to the patients who need them. This benefits the drug industry through a less arduous review process for expanding indications. Those who oppose the bill express concern that patients would be taking these drugs without proper testing for safety and efficacy.
Faster Device Approval
Device companies would benefit through a proposed “breakthrough device” program which would bring devices to market faster if they’re perceived to substantially raise the standard of care. In addition, the “humanitarian device exemption” would be expanded. Currently, devices that treat a disease affecting fewer than 4,000 people receive less regulatory scrutiny for approval. The passage of the bill will expand the exemption to include diseases affecting fewer than 8,000 people.
Increased Funding for Medical Innovation
Although the 21st Century Cures Act adds duties to an already overburdened FDA, it is slated to increase their funding by $550M over five years.
While not as legislatively substantial, the National Institutes of Health (NIH) also stands to benefit financially from the proposed bill. In addition to increasing funding $10B over five years, the bill would create an NIH Innovation Fund, supported by an additional $2B per year. The Innovation Fund is designed to support the growing trend of precision medicine. Young emerging scientists and groundbreaking medical innovations stand to benefit from the proposed changes.
Pro and Con Implications
While the implications for major organizations such as the FDA and NIH are large, the American Hospital Association urges voters to be cautious of the proposed bill. While the ability to have medications and devices enter the market faster is desirable for many people, there are those that question the quality of the drugs that will enter the market under the new guidelines. Because the regulations are expected to be more relaxed, will the quality of review be as high as it is today?
Do you think the 21st Century Cures Act should be embraced, or should we be wary of faster turnaround times for clinical trials? What other areas should the bill focus on?
Don’t miss part two of this piece next week, covering interoperability requirements and telemedicine regulations.