The 21st Century Cures Act has been in the works for three years. The most significant items on its agenda gives way to faster prescription and medical device approval. Party leaders on both sides are expecting this to pass the Senate. But will this new speed lower safety standards? Voting against this bill would be denying cancer research and help for opioid addiction. Voting for it can weaken the regulations on medical devices, allow drugs on the market with limited evidence of safety, and rush the use of new unapproved antibiotics. If passed the FDA will be allowed to consider real world evidence provided by companies which is a summary rather than the full evidence of a clinical trial. However its benefit to pharmaceutical, medical device, mental health, substance abuse advocates, patient advocacy groups, and National Institutes of Health may out weight those detrimental items. This bill was first denied due to lack of funding. The solution was found by cutting the budget for Prevention and Public Health by almost 30%. This caused some resentment with preventative medicine and consumer safety groups but was still supported and will likely pass because of its large amount of benefits.
For further reading on this article visit STAT News – House approves the 21st Century Cures Act, sending landmark bill to Senate. Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation, also explains more in depth the benefits and disadvantages of the act.