CPhI Worldwide Annual Industry Report member and president of EPCOT International, Girish Malhotra, has stated that if ANDA approval time is reduced from ten to three months the cost of drugs will be lowered.
Cutting costs
To decrease the time for ANDA approvals there are three main challenges that need to be overcome. The first challenge is submission completeness. Currently, the FDA has a 45-day review period to determine the completeness of an application, which can be reduced to 15 days if there is a modification to FDA processes.
A Pre-ANDA programme was proposed last month that offers an initial quality by analysis (QbA) implementation in the application filing process. The aim behind this is to have a template application covering the majority of the filing requirements, as even though product applications are different the filing requirement information is essentially the same.
However, for this to function there would need to be a clear and concise specification of what is required from companies within the application and this would then need to be translatable into a standard template. “Workshops that train the FDA industry staff to become familiarised with the application requirements would allow the Pre-ANDA programme to be implemented efficiently,” Malhotra said.
The second challenge is the volume of applications. This can be minimised if the FDA employs a streamlined best basis planning scenario strategy. Additionally, the delay of generic entry into the market must be prevented but those generics must not be approved until the patent on branded products expires. “If the approval process were lowered to three months the need for priority review would likely disappear entirely,” added Malhotra.
Finally, he explains that the 90-day frame can be broken down into three sections. The initial FDA review, lasting 15 days, then the company response time, 30 days, and lastly a 45-day period for the FDA to review the application and give its final proposal. If companies are unable to fulfil obligations after the 15-day FDA review and the 30-day deficiency completion will then need to re-start the whole process. Malhotra asserts that this should encourage companies to ensure they provide the best possible application in the first instance.
“I keep banging the drum, but not enough of the industry is willing to change,” he said. “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.”