US government advances five bills to increase generics competition

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US government advances five bills to increase generics competition

Home/Policies & Legislation | Posted 12/04/2019 0 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.

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.

FDA publishes list of companies that block generics

Pay-for-delay bill reintroduced

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

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Source: US House Committee on Energy and Commerce