Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, discusses the necessity of time reduction for ANDA approvals, arguing that if the current approval time can be reduced from ten months to three months, drug costs will decrease.
Malhotra states that in order to decrease the time for ANDA approvals, there are three main challenges to overcome. Currently, it takes up to four review cycles to approve an ANDA, and the first and foremost challenge is with submission completeness. On average, it takes the FDA reviewing team 45 days to determine application completeness. This time can potentially be reduced to 15 days if the FDA modifies their review process. Last month the Pre-ANDA program was proposed, a first-step Quality by Analysis (QbA) implementation in the application filing process. Although applications for every product are different in content, the information filing requirements are essentially the same.
For example, a template application that covers 90% of the filing requirements can be designed whereby a standard format could reduce four reviews to a single review. However, to avoid confusion and delay, the FDA would have to create applications that clearly state what is expected from companies; this must then be transformed into a standard template. “Workshops that train the FDA industry staff to become familiarized with the application requirements would allow the Pre-ANDA program to be implemented efficiently”, Malhotra explained.
The volume of applications is the second challenge, which can be minimized if the FDA goes with a streamlined best basis planning scenario strategy. Brand companies use Risk Evaluation and Mitigation Strategies to delay generic entry and so the FDA must develop a strategy to prevent such harassment. FDA or US legislature has to intervene and assure that necessary samples are available to potential generic companies to complete necessary studies for approval. In addition to this, the FDA cannot approve generics until the patent on a product expires. Malhotra added, “If the approval process were lowered to three months, the need for priority review would likely disappear entirely”.
Lastly, the 90-day frame can be further broken down into three segments. The FDA will complete the initial review within 15 days and companies would then have 30 days to respond to FDA’s requirements. Following this, the FDA will then have 45 days to review the application and return to the company with a final proposal. Companies that cannot fulfill obligations after the 15-day FDA review combined with the 30-day deficiency completion will be required to start the process over. This will encourage companies to ensure that they provide the best application possible.
Malhotra said: “I keep banging the drum, but not enough of the industry is willing to change. Until we take on challenges, progress will never be made. It will be worth it if we can make regulatory process improvements and consequently lower the overall cost of drugs.”