What does it mean for our patients?
Big Pharma is celebrating a new year with the historic passing of the 21st Century Cures Act, which implements a number of regulatory changes throughout the industry. Beyond its $6B funding for medical research, the bill is set to speed up review for new medicines and equipment, bringing them to market much faster than before.
Experts have expressed mixed opinions on the legislation, worrying that the changes may sacrifice quality and safety over quantity. Still, the majority of patient advocacy groups support the bill for its improvement of the FDA’s tirelessly drawn-out review process. Up until now, new products were subject to months of stringent evaluation according to their “risk” factor—and this is after years of laboratory development and clinical trials.
For those of us in the nursing field, the 21st Century Cures Act proves a beacon of hope for many suffering patients. One key aspect of the bill is that it will prioritize review for drugs and devices deemed “breakthrough,” a label sponsors may pursue if the product can diagnose or treat a life-threatening condition. When individuals have only months or years to live, these revolutionary products may significantly improve their quality of life—or potentially offer a cure—just in the nick of time.
The bill makes two other key changes to current practice:
- The FDA will now be able to use new types of real-world data to support clinical trial findings. This will allow manufacturers to speed up the review process by using existing patient health records—as opposed to those solely produced for FDA consultation.
- Trials for antibacterial drugs, which are typically difficult to find participants for, may now be conducted with fewer patients. The studies will finish much quicker, allowing important antibiotics to arrive on the market sooner.
While President Obama’s signing of the legislation may celebrate innovation, it also gives rise to plenty of skepticism over the quality of products soon-to-be approved under the bill’s measures.
If companies give precedence to any data over quality data, new drugs and devices could pose serious harm to consumers. While it’s too early to tell the long-term effects of the bill and its impact throughout the industry, experts will surely continue to weigh in over
Just keep delivering quality
care to your patients while
stays on the case!