FDA forms working group to increase generics competition Posted 22/09/2017

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb had announced the creation of a working group of senior staff focused on increasing generic drug competition.

Although generic drugs have saved the healthcare system over US$1.6 trillion in the past 10 years, cost remains an issue. In the US, the number of generic drugmakers has decreased in recent years and, consequently, prices have risen.

FDA has recently taken several steps to encourage competition in the generic drugs market, including approving generics faster [1] and listing all brand-name drugs without patent protection that do not yet have an approved generic [2].

As part of their ‘Drug Competition Action Plan’, the Agency have now announced plans to create a generics competition working group of senior members. The group aims to find new ideas to increase generic drug competition, and therefore access.

In a statement on their website, Dr Gottlieb suggested regulation is ‘gamed’ and ‘misused’ by pharmaceutical companies to delay generic drug approvals and reduce competition. A well-known tactic is making branded products unavailable for testing, which is essential for submitting a generic drug application (abbreviated new drug application, or ANDA).

Dr Gottlieb said brand-name drug manufacturers might be using ‘regulatory strategies or commercial techniques to deliberately try to block a generic drug company from getting access to testing samples’. He also described difficulties accessing samples when branded products have limited distribution, for example, as part of a Risk Evaluation and Mitigation Strategy (REMS) programme. Branded drug manufacturers can use these arrangements to stop generic drugmakers from accessing samples for testing.

Dr Gottlieb also said he would be working to better coordinate with the Federal Trade Commission (FTC), which is responsible for preventing anticompetitive business practice. Around 150 complaints from generic drug manufacturers have been passed on to the FTC and reviewed for allegations of preventing fair competition. The group will also work to modernize the Hatch-Waxman Act, which was implemented in 1984 and regulates generic drug approvals in the US.

Taking to Twitter, Dr Gottlieb said the group aims to ‘think beyond current policy proposals’ and ‘find new ideas for greater generic drug access’. Members include: Elizabeth Dickinson, an FDA attorney in the Office of the Chief Counsel; Grail Sipes, Director of the Office of Regulatory Policy at the Center for Drug Evaluation and Research (CDER); and Maryll Toufanian, Deputy Director of CDER’s Office of Generic Drug Policy.

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References
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 Sep 22]. Available from: www.gabionline.net/Generics/General/FDA-targets-rising-drug-prices-by-increasing-generics-competition
2. GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition

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Source: US FDA

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