FDA lists drugs without generics to increase competition

Generics/General | Posted 07/07/2017 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 27 June 2017 that it had taken ‘two new, important steps’ to increase competition and encourage the entry of generics in the US.

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FDA published a list of brand-name drugs that no longer have patent protection or exclusivity in the US and that do not have approved generics. The list is divided into two parts. Part I contains drug products for which FDA could immediately accept an abbreviated new drug application (ANDA) without prior discussion. Part II identifies drug products involving potential legal, regulatory, or scientific issues which should be addressed with the agency prior to submission of an ANDA.

In addition, the agency implemented, for the first time, a new policy to speed up the review of generics applications where competition is limited. This means that for drugs on the list FDA will expedite the review of the generics application ‘to ensure that they come to market as expeditiously as possible’.

The agency also intends to ‘expedite the review of generic drug applications until there are three approved generics for a given drug product’. This is the point at which prices start to fall significantly, according to FDA Commissioner Scott Gottlieb [1].

These actions are being taken under the auspices of the agency’s Drug Competition Action Plan.

Dr Gottlieb said that ‘too many patients are being priced out of the medicines they need’. Although he also said that the ‘FDA doesn’t have a direct role in drug pricing’, he added that ‘we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines’. 

The agency is planning to hold a public meeting on the subject of access to medicines on 18 July 2017. The aim of the meeting is to ‘solicit input on places where FDA’s rules – including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended’.

Finally, Dr Gottlieb said that he was ‘committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need.’

1. GaBI Online - Generics and Biosimilars Initiative. FDA targets rising drug prices by increasing generics competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Generics/General/FDA-targets-rising-drug-prices-by-increasing-generics-competition

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Source: Federal Register, US FDA

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