US FDA has created a fantastic opportunity for incorporation of the best manufacturing technologies in the pharmaceutical hemisphere by charging fee for every generic company globally. The carrot of early approval if that happens will drive to have the best processes for API & formulation if the companies want to produce repeatable quality and safe drugs. Early approvals also will mean quicker profits compared to the current status. It would be a win-win.
Early approval will require that the processes meet the regulatory requirements on the first pass. QbD will have to be the mantra. This can happen only when the filing company has command of the process through best of the manufacturing technologies. It would be in companies’ interest to implement technologies to recover cost of fees. Having the best of the technologies will also mean the companies that cannot meet the regulatory standards after paying fees will have to review their long-term business strategies. Best will survive. Long-term this could result in consolidation. Lower costs could be in the horizon also.
Consolidation would have additional benefits of capitalizing on economies of scale i.e. better manufacturing technologies and processes will be the driver for the companies to stay in business. Better quality drugs will mean that many of the TLA’s (three letter acronyms) that are prevalent in pharma will fit in the puzzle and might not be needed. QbD and PAT will become way of life rather than perceived voodoo science as many think. Before the fact rather than after the fact will force competition.
I firmly believe adoption of fees will be the best happening for the generic pharmaceutical companies. Companies who believe in technology will survive. Congratulations and thank you to all individuals who have been involved in driving this discussion.
Girish Malhotra, PE
EPCOT International
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