Earlier this year, the FDA took bold steps, launching them closer to efficient rare disease drug development. And now, the potential improvement for rare disease patients could be huge.
Why?
Because drugs could get to consumers a whole heckuva lot faster than they do now.
Based on the everydaylifefoundation’s website, the FDA’s plan, if approved, says if there are no adverse findings to a drug in development, then it could move forward and only require three months of chronic toxicology animal studies before it hits consumers. Talk about a difference.
The new protocols would be more similar to European standards, which are less traditional. Any FDA processes prior to their new guidances, thwarted opportunity for early-stage clinical trials, which only delayed consumer access to the medicines that could literally save their lives.
Additionally, the new approach would be more “scientifically rational.” Plus, it’ll reduce costs, and everyone loves reduced costs. But, all-in-all, the ultimate goal is to decrease the amount of United States patients who aren’t able to access early-stage clinical trials. Period.
For patients with rare diseases, this FDA breakthrough could mean everything. Steps are being taken to ensure that patients have access to a drug as soon as it’s possibly available. The sped up process will make a difference in the lives of people who battle rare diseases–not only make a difference in their lives, but it could very well save it.
