Currently, it takes multiple review cycles – and up to 10 months – for the FDA to approve an Abbreviated New Drug Application (ANDA). In my view, this is a fundamental flaw with the system and we need to find a way to fix it. We improve every repetitive task to facilitate our daily lives – and in pharma we also constantly improve manufacturing processes – so why not improve the ANDA application filing and approval process? I keep banging the drum, but not enough of the industry is willing to face the challenge. I am not questioning the authority of the FDA or other government bodies, but I do believe that as an industry we need to consider how we can refine our processes. Yes, this is a challenging task, but until we take on the challenges, progress will never be made. And it will all be worth it if we can make regulatory process improvements that allow us to consequently lower the overall cost of drugs.
I believe that we could potentially reduce ANDA approval times by two thirds – from 10 months to three months. To achieve this reduction, there are two main challenges that we need to overcome as an industry. The first and foremost challenge relates to submission completeness. It takes, on average, 45 days for the FDA reviewer to determine application completeness. Fortunately, the FDA itself also seems to be interested in making some changes. In March 2017, the Pre-ANDA program was proposed by the FDA, with the goal of clarifying regulatory expectations for prospective applicants early in product development, and reducing the number of review cycles to obtain ANDA approval. But perhaps we can push this further. Much like manufacturing processes, applications for every product are going to be different when it comes to content, but the information filing requirements are essentially the same. For example, the use of a template application/standard format that covers 90 percent of the filing requirements could reduce four reviews down to a single review. To avoid confusion and delay, the FDA would have to clearly state what is expected from companies. Workshops designed to train industry staff on the application template and requirements would allow the Pre-ANDA program to be implemented efficiently. I know such processes work from my own personal experiences – we had a similar process at the Illinois Environmental Protection Agency in 1972 for various industry segments, with timelines from submission to approval of equipment design and operating permits. Based on our questions, every industry submitted relevant information that facilitated review and approval.
The second challenge stems from the volume of applications – a difficult issue to address. But perhaps applications can be minimized if the FDA considered a more streamlined process. The agency’s operational finesse strategy may have to change, but many businesses deal with such changes. There are additional elements that the FDA would need to consider; for instance, given that brand companies use risk evaluation and mitigation strategies to delay generic entry, the FDA must develop its own strategy to prevent such harassment. And the FDA or US legislature may also need to intervene and assure that necessary samples are available to potential generic companies to complete their studies for approval. Another interesting point I would like to raise is that if the ANDA approval process was lowered to three months, the need for “priority review” would likely disappear entirely. Finally, the 90-day timeframe can be broken down into three segments. The FDA could complete the initial review within 15 days; companies would then have 30 days to respond to the agency’s requirements. The FDA would then have 45 days to review the application and return to the company with a final proposal. Companies that cannot fulfil all obligations after the 15-day FDA review and the 30-day deficiency completion would have to start the process over. The result? Faster review times – and companies would be encouraged to get it right the first time around.
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