FDA Drug Review & Approval Times Reduced Drastically

Report: FDA’s Drug Review & Approval Times Reduced Drastically Since 2009

FDA Drastically Reduced Review & Approval Times Since 2009

According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009.  The infographic, entitled “Tracking FDA Drug Review Performance”, was developed in collaboration with The Boston Consulting Group and provides details on the Agency’s drug review and approval times over the last 15 years, without specifically noting what types of submissions are included in the analysis.

Paying particular attention to the last six years, the infographic shows a steady decline in review times between 2009 and 2015.  More precisely, the average review time in 2009 was 21 months, but by 2015 that number reduced to just ten months, dropping the average overall review time by more than 50%.

While the infographic shows that FDA’s overall review times have been cut drastically, there are still rather wide variations that exist among different therapeutic areas.  Due to various provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA), it is not surprising that indications such as oncology, infectious diseases, and rare diseases have the fastest approval times.  However, it is also important to note that endocrine, gastrointestinal, and CNS therapies continue to struggle with average times that lag behind the rest of the pack.  Furthermore, CLSA states that although disparities still exist across therapeutic areas, “the gap has significantly narrowed over the last five years.”

CLSA’s report credits the Breakthrough Therapy Designation, which was introduced by FDASIA in 2012, with the Agency’s improved review and approval times.  The Breakthrough Therapy Designation was designed to expedite the development of drugs for serious conditions, which is achieved by shortening the review timelines for certain submissions to just 60 days.  To wrap up its report, CLSA reminds FDA, Congress, and the biopharmaceutical industry that there is “a great opportunity to replicate those improvements across all therapeutic areas,” and asks them to take this into consideration when negotiating the next series of user fees.

Although the infographic and CLSA’s press release do not detail what was studied and how they reached the numbers reported, we do know that the FDA is actively working to reduce drug review times.  Moreover, we also know that, while the Agency has been successful in its recent efforts, having an effective strategy and submission are critical factors in reducing the amount of time it takes for FDA to review your application.  We can help you develop these items, achieving a successful interaction with FDA in less time and for less money.

Do you have a product that may be eligible to receive Breakthrough Therapy Designation?  We can help determine if your drug is eligible for this designation or others. To learn more about our services and how we can help you, contact us today.