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.
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FDA Released Draft Guidance on Common Issues in Rare Disease Drug Development
After the FDA passed the Orphan Drug Act in 1983, the number of orphan drugs (drugs indicated for the treatment of rare diseases that affect 200,000 people or less in the United States) submitted to...