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.

59 MD002189

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].

Related article
Hilary Clinton goes after Valeant for ‘predatory pricing’

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

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

comment icon Comments (0)
Post your comment
Related content
Public consultation for the modification of the biosimilars regulation
02 AA010638
Home/Policies & Legislation Posted 16/01/2024
COFEPRIS promotes regulatory cooperation in the Americas
Latin America 1638px
Home/Policies & Legislation Posted 12/12/2023
ANVISA's decision on 'Skinny labels' for generics pending
Labelling V14I26
Home/Policies & Legislation Posted 14/11/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010