US government advances five bills to increase generics competition

Home/Policies & Legislation | Posted 12/04/2019 post-comment0 Post your comment

The US House Energy & Commerce Committee’s Health Subcommittee has advanced five bills related to generic drug competition. The bills have not yet been passed but will each be considered by the full committee.

88 MD002468

The bills put forward by the Energy & Commerce (E&C) Committee’s Health Subcommittee confront a range of issues which make it difficult for generics manufacturers to get a drug to market, which limits competition in the US pharmaceutical market.

Of the five bills to be advanced, the ‘Protecting Consumer Access to Generic Drugs Act of 2019’ (H.R. 1499) aims to prevent brand-name drugs manufacturers from compensating generics manufacturers to delay entry. Known as ‘pay-to-delay’, several companies have been found guilty of this practice in recent years [1].

Some Republicans on the subcommittee argue that this law could remove existing generic drugs from the market, if they were found to have taken part in an unlawful agreement at any time since 2013. An amendment was offered that would remove the retroactive element of the bill, but it was not agreed to by the house.

A further practice employed by some pharmaceutical companies is to prevent generics manufacturers from accessing samples of reference product, which are required for testing and approval by the Food and Drug Administration (FDA). This practice is the focus of H.R. 965, also known as the CREATES Act of 2019.

The Act (which was first introduced in 2017 [2]) has faced opposition from Republicans for what they described as ‘grossly excessive’ damages for brand-name manufacturers that do not provide access to samples of their drugs.

Democrat Peter Welch however suggested that the aim of the Act is to prevent companies from ‘ripping off consumers’ and that the damages ‘are reflective of the revenue stream’. The Democrats further clarified that the penalties would not exceed that of the revenue made during the period the company did not provide samples for a particular drug product.

The final three Acts are the Blocking Act of 2019 (H.R. 938), which would remove the barrier to approval created by the 180-day exclusivity period, which is given to a first generic applicant that has not yet received final approval. This bill could save as much as US$1.8 million.

The Orange Book Transparency Act (H.R. 1503) would remove invalid patents and add patents for drug delivery devices to the reference guide for generic drug manufacturers. Finally, the Purple Book Continuity Act (H.R. 1520) would similarly reform the reference guide on biosimilars to include new patent information.

Related articles
FDA approves more generics in 2018 than any other year

FDA publishes list of companies that block generics

Pay-for-delay bill reintroduced

1. GaBI Online - Generics and Biosimilars Initiative. Generics companies defend against illegal ‘pay-for-delay’ charges []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from:  
2. GaBI Online - Generics and Biosimilars Initiative. New bill would stop brand-name pharma restricting drug samples []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from:

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 © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: US House Committee on Energy and Commerce

comment icon Comments (0)
Post your comment
Related content
Generic ‘skinny’ labelling under threat in the US
Label prescription drugs
Home/Policies & Legislation Posted 05/11/2021
FDA publishes final Q&A on biosimilar development and the BPCI Act
Home/Policies & Legislation Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
Home/Policies & Legislation Posted 08/10/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010