FDA targets rising drug prices by increasing generics competition Posted 16/06/2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb is advocating reducing drug costs by approving cheaper generics faster.

Dr Gottlieb was voted in as the next head of FDA in a split vote from the US Senate on 9 May 2017, which voted 57-42 in favour of his appointment.

In his first remarks to FDA staff, Dr Gottlieb said that while the ‘FDA doesn’t play a direct role in drug pricing’; it can take ‘meaningful steps to get more low cost alternatives to the market’. He said the agency needs to ‘take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers’.

He has also been reported to say that he ‘would make streamlining approvals his top priority’. In this area his focus would be particularly on complex medications that combine old drugs with newer delivery devices, as well as those with unusually complicated formulations. Getting these types of drugs approved in the US is a difficult process, as has been highlighted in the Advair (fluticasone/salmeterol) case [1-3]. But, according to Dr Gottlieb, adding generics competitors would mean lower prices. His goal is to have three manufacturers of every generic version of a drug, as he says this is the point at which prices start to fall significantly.

Dr Gottlieb also told a congressional panel that the agency is crafting a ‘drug competition action plan’ aimed at expediting approval of generics of brand-name medications that lack competition. The agency is also looking at ways to reform the Risk Evaluation and Mitigation Strategy (REMS) regulations to prevent companies from abusing them. Toward this end the FDA issued draft guidance on REMS in September 2016 and bills have been introduced in both the House and Senate that would allow generics makers to sue brand-name firms that abuse REMS by withholding samples [4].

References
1. GaBI Online - Generics and Biosimilars Initiative. Making generics of Advair could be difficult [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Generics/News/Making-generics-of-Advair-could-be-difficult
2. GaBI Online - Generics and Biosimilars Initiative. Mylan poised to enter generic inhalers market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Generics/News/Mylan-poised-to-enter-generic-inhalers-market
3. GaBI Online - Generics and Biosimilars Initiative. Sandoz petitions FDA over requirements for generics of Advair Diskus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Generics/General/Sandoz-petitions-FDA-over-requirements-for-generics-of-Advair-Diskus
4. GaBI Online - Generics and Biosimilars Initiative. New bill would stop brand-name pharma restricting drug samples [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Policies-Legislation/New-bill-would-stop-brand-name-pharma-restricting-drug-samples

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Source: Bloomberg, Lexology, RAPS, US FDA

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