The report investigated the way the agency reviews applications for drugs and biologics that have not previously been FDA-approved. It was commissioned to look at differences in applications approved by the agency during the first round of review (first-cycle) compared to those applications that took multiple reviews (multi-cycle) before approval.
One of the most compelling findings was the positive impact ‘milestone meetings’ held between a product sponsor and the FDA can have in making the drug review process more efficient by improving the quality of initial applications.
The report, entitled Independent Evaluation of FDA’s First Cycle Review Performance – Retrospective Analysis, showed the positive impact consulting with the FDA before beginning the final phase of human testing (end of phase II) can have on first-cycle approval rates.
The report found that 52% of companies that held a meeting with the FDA at the end of phase II trials received approval during the first review cycle. However, only 29% of sponsors that did not have consultation meetings in this phase gained approval during the first review cycle for their product.
In addition, the report also noted a positive link between a first-cycle approval and an earlier consultation before the application is even submitted – of 58 products with these types of meetings, almost half received first cycle approval.
“These meetings have become one of the most valuable aspects of the drug development process,” said acting FDA commissioner Dr Andrew von Eschenbach. “Earlier consultation and feedback from FDA on the sponsor’s development program is critical to ensuring safe and effective study designs and increasing the probability that the resulting marketing application will meet regulatory requirements.”
The report also notes that, even when major issues with an application are identified by the FDA in milestone meetings, the sponsor did not always adequately address them before submitting the application. In fact, 71% of applications where key issues were identified by FDA during pre-submission meetings were not adequately resolved by the sponsor by the time of first action.
As a result of this independent analysis, the report recommends that, in order to further improve first-cycle approval rates, the FDA should play a “much more proactive role” throughout the development process. Consulting firm Booz Allen Hamilton, which conducted the study, also recommended that this will help the agency to better work with the sponsor to identify and communicate issues and potential deficiencies earlier on in the review process.
The report also recommended that the agency actively follow up with sponsors after milestone meetings to ensure the sponsor has adequately addressed issues identified during the meetings. The report notes, however, that implementing the recommendations would have significant resource implications for FDA given current workload and staffing in the reviewing divisions.