New bill would stop brand-name pharma restricting drug samples

Home/Policies & Legislation | Posted 01/07/2016 post-comment0 Post your comment

A new Senate bill would stop brand-name drugmakers from blocking generics competition by closing regulatory loopholes preventing generics makers from obtaining samples of the reference materials needed to test candidate generics and biosimilars.

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The bipartisan legislation aims to ‘end inappropriate delay tactics that are used by some brand-name drug manufacturers to block competition from more affordable generic drugs’.

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was introduced to the US Senate on 14 June 2016 by members of the Senate Judiciary Committee Patrick Leahy, Chuck Grassley, Amy Klobuchar and Mike Lee.

The bill addresses two delaying tactics used by brand-name pharma companies:
• The first involves withholding of drug samples that generics makers need to gain regulatory approval. This simple delay tactic uses regulatory safeguards as a weapon to block competition. The US Food and Drug Administration (FDA) has reported receiving more than 100 inquiries from generics developers who were unable to access samples of a brand-name drug to compare their generic drug product.
• The second involves the development of shared safety protocols under Risk Evaluation and Mitigation Strategies (REMS). For some high-risk drugs, federal law requires a generics maker to join the brand-name drug manufacturer in a single, shared safety protocol for distribution of the drug. Despite this requirement, some brand-name companies are refusing to negotiate a shared safety protocol with potential generics competitors, again undermining those competitors’ ability to gain FDA approval for their generic version of the drug.

The bill has been backed by 19 physician, pharmacist, hospital and consumer groups, including the Generic Pharmaceutical Association (GPhA), Public Citizen and the largest US pharmacy benefit manager, Express Scripts. While others, including biosimilars developer Pfenex, The Campaign for Sustainable Rx Pricing (CSRxP), and the American Hospital Association (AHA) have applauded its introduction.

This is not the first time misuse of REMS has been brought to the attention of US lawmakers. Earlier in 2016, the CSRxP released a document outlining 12 policy proposals to reduce drug costs in the US, which included curbing the misuse of REMS [1]. While in June 2015, US lawmakers Steve Stivers and Peter Welch re-introduced the Fair Access for Safe and Timely (FAST), which aims to ‘close federal loopholes to ensure consumers have faster access to less costly generics by increasing market competition and eliminating bureaucratic red tape’ [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Healthcare alliance proposes ways to reduce drug costs in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. FAST generics act re-introduced to increase generics competition []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from:

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Source: AHA, CSRxP, GPhA, Patrick Leahy, Pfenex

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