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FDA to expedite complex generic approvals to lower drug prices through competition

Published on 03/10/17 at 09:39am

In the midst of ongoing discussions over drug pricing, the FDA has announced plans to facilitate accelerated access to generic versions of complex drugs

The action comes after a year of Donald Trump’s pledges to bring down drug pricing. While little action has been taken so far, his tirades and pressure from Congress have meant that the FDA is now focusing on the issues of pricing and access, which has not typically been the case in the past – traditionally, the FDA has assessed safety and efficacy of medicines, while congress dealt with pricing.

“If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address,” said FDA Commissioner Scott Gottlieb.

“Drug access is a matter of public health concern. We know that enabling more generic competition, where Congress intended, helps reduce prices, enable more access, and improve public health.”

But many complex medicines are exempt from the competition, given that complicated drugs such as metered-dose inhalers have at least one feature that is difficult to replicate under existing rules.

“In some cases, costly, branded drugs that are complex drugs have lost their exclusivity but are subject to no generic competition,” Gottlieb said.

The pricing debate has been a huge topic of discussion of late, drawn back into the spotlight by Mylan’s EpiPen pricing scandal last year. Despite facing congressional hearings over its own price hiking practices, the manufacturer has complained over delays in accessing the market with its own generic versions of complex drugs, such as GSK’s asthma treatment, Advair.

Matt Fellows

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