As Americans grapple with sometimes unpredictable generic drug pricing, a group of academics argue there may be a way to mitigate the problem. They suggest that the Food and Drug Administration should be authorized to speed approvals of copycat medicines that were already endorsed by regulators in other countries in hopes of providing fresh supplies that might lower prices.
The rationale is there are enough foreign regulators — such as in Canada, Europe, and Australia — that take a similarly stringent approach to the FDA for approving generic drugs. And as they see it, this form of reciprocal approval could increase competition by providing incentives for companies to enter the U.S. market and lowering the cost of FDA approvals, according to their analysis, which was published in BMJ.
“There is already this supply of drugs approved by other peer regulators that FDA isn’t considering and perhaps should,” said Ravi Gupta, one of the authors and an internal medicine resident at Johns Hopkins School of Medicine. “The hope is it would limit price increases and maintain reasonable prices for drugs with the goal of expanding patient access and making them affordable.”