New Drug Regulations in House of Reps
On Friday, the US House of Representatives passed a bill, called the 21st Century Cures Act, that may speed up the process for drugs to make it to the market.
As reported by Reuters, this decision – coming at a vote of 344 to 77 – “will allow for new drugs to make it to the public market much quicker than the current regulations allow.” This will be done as per the Act’s requirements, specifying that the FDA to make their journey to the market occur smoothly, while opening the possibility of more inclusive regulations. Some guidelines that the Act includes are flexible clinical trials to test the safety and vitality of each drug, and the utilizing of patient experience in the final approval. The FDA’s current framework would be completely overhauled and recreated to fit the implementations of drug approval.
The 21st Century Cures Act was developed by the House Energy and Commerce Committee. A similar bill is expected to be voted on by the Senate later this year, and the success of the 21st Century Cures Act leaves open the possibility for its passing as well.
So, What Are the Regulations?
The House bill does come with specific regulations and guidelines for the FDA to follow in its new overhaul of drug approval methods. There would be an increase in funding for the National Institutes of Health by almost $9 billion over a five-year time period, while also increasing funding for the Food and Drug Administration. An upside to this would be the increased incentives for major pharmaceutical companies to create drugs that focus on specific and not-so-common diseases. There would also be a speedier timeframe for antibiotics to be approved, as it will have fewer testing trials to undergo.
21st Century Cures Act’s Effect on Healthcare Regulations
In short, this bill has the potential to shift how drug companies and the healthcare field interact with each other and their patients. And while many will be watching carefully to examine just how the 21st Century Cures Act will be utilized to best address patient concerns, there is still the hope that the passing of this bill, along with others, will allow for a better examination of solution addresses within the healthcare field.
