According to Rep Stivers, the bill ‘closes federal loopholes to ensure consumers have faster access to less costly generics by increasing market competition and eliminating bureaucratic red tape’.

The bill aims to solve the problems generics companies often have getting their hands on samples of the originator drug in order to carry out bioequivalence trials. It is believed that some companies are abusing US Food and Drug Administration safety programmes, such as the risk evaluation and mitigation strategy (REMS), as a reason to withhold access to drug samples for generics makers. This results in anticompetitive practices and increased costs for both payers and patients.

Abuse of REMS and REMS-like programmes has been estimated to cost the American healthcare system and its patients US$5.4 billion annually. Should these practices extend to biosimilars, US$140 million in savings would be lost for every US$1 billion in biologicals sales, according to a study by Matrix Global Advisors.

The FAST Generics Act includes common sense reforms to close these loopholes and address the most common abuses of REMS and non-REMS restricted access programmes.

The Generic Pharmaceutical Association, which represents the generics industry in the US, has applauded the congressmen for introducing the bill, which they hope will close the loopholes for abuse of REMs and non-REMs restricted access programmes.

Generics companies have even had to resort to bring lawsuits against originator companies in the past in order to get samples of the originator drug. While the US Federal Trade Commission has come out in support of generics companies trying to get hold of brand-name drugs in order to make generic versions [1].

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US FTC sides with generics makers over drug samples [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from: www.gabionline.net/Policies-Legislation/US-FTC-sides-with-generics-makers-over-drug-samples

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