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CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.
Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, has called for approval timeframes of abbreviated new drug applications (ANDAs) to be reduced. He argues that drug costs could be lower if approval timeframes can be cut from 10 to three months.
According to Malhotra, there are three main challenges that must be tackled in order to speed up ANDA approvals, which currently take up to four review cycles before an ANDA is approved. The first challenge is submission completeness. FDA, on average, takes 45 days to determine if an application is complete. Malhotra believes this time can potentially be reduced to 15 days if FDA modifies their review process. The Pre-ANDA program has been proposed, a first-step quality by analysis (QbA) implementation in the application filing process. Although applications for every product will have different content, the information required is the same.
A template application that covers 90% of the filing requirements, for example, can be designed such that a standard format could reduce four reviews to a single review, Malhotra says. However, to avoid confusion and delay, FDA would need to create applications that clearly state what is expected from companies; the requirements 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 explains.
Volume of applications
The volume of applications is the second challenge, Malhotra highlights. He points out that this problem can be minimized if FDA adopts a streamlined best basis planning scenario strategy. Brand companies use risk evaluation and mitigation strategies to delay the entry of generic drugs; FDA must, therefore, develop a strategy to prevent such harassment. FDA, or the US government, has to intervene and ensure that necessary samples are available to potential generic drug companies to complete necessary studies for approval. In addition, FDA cannot approve generic drugs until the patent of a product expires. If the approval process were lowered to three months, the need for priority review would likely disappear entirely, Malhotra argues.
The 90-day frame
Lastly, the 90-day frame can be further broken down into three segments, says Malhotra. FDA will complete the initial review within 15 days and companies would then have 30 days to respond to FDA’s requirements. Following this, 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. Progress will not be made, unless challenges are tackled, says Malhotra. He believes that regulatory reform is worth a try because it could potentially lower the overall costs of drugs.
The CPhI Pharma Insight reports and the CPhI Annual Report can be found at: