US FDA unveils steps to expedite generic drugs availability in the market

US FDA unveils new policy will expedite review of generic drug applications where competition in limited, publishes list of branded drugs whose patents have expired but their generic versions aren't available

Isha Trivedi
Updated27 Jun 2017
US FDA has also published a list of branded drugs whose patents have ended but their generic versions aren’t approved yet. Photo: Bloomberg
US FDA has also published a list of branded drugs whose patents have ended but their generic versions aren’t approved yet. Photo: Bloomberg

Mumbai: The US Food and Drug Administration (FDA) on Tuesday announced two measures that will facilitate entry of generic drugs in the market, which will increase competition and offer low-cost alternatives to patients.

The two steps are: one, the US FDA has published a list of branded drugs whose patents and exclusivity periods have ended but do have any generic versions approved as yet; and two, US FDA has implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

These actions are among the first taken under the regulator’s Drug Competition Action Plan announced by US FDA commissioner Scott Gottlieb in late May, the regulator said in a press statement.

The US is the biggest market for most leading Indian pharmaceutical companies.

The list of off-patent branded drugs, which will be updated every six months, is aimed at encouraging companies to develop generic versions of those drugs. The US FDA also intends to fast-track the review of any generic drug application for a product on this list to ensure that they come to market as early as possible.

Moreover, the US FDA will expedite the review of generic drug applications until there are three approved generics for a given drug product.

On 23 June, Gotllieb had said in an official blog that the US FDA will hold a public meeting 18 July to solicit input on places where the US FDA’s rules are being used in ways that may create obstacles to generic access, instead of ensuring competition.

Over the last decade alone, generic drugs saved the US healthcare system about $1.67 trillion, the commissioner said in the blog. The FDA has observed that innovator companies use certain regulatory norms to delay or block entry of generic drugs in the market and is looking to modify such rules, he had said.

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