On 13 November 2019, the House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill aimed at preventing companies from using citizen petitions to delay the approval of generics.
The Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019 is bipartisan legislation introduced by Representatives Levin and Rooney. The Act aims to help address the abuse of citizen petitions that delay or impede generics from entering the US market. The legislation enhances the US Food and Drug Administration’s (FDA) authority to swiftly dismiss anti-competitive petitions. The policy has bipartisan support in the Senate and from the Administration. It is also another step in trying to remove barriers that prevent cheaper generics from reaching the US market.
The bill (HR 2387) gives FDA the power to deny petitions whose primary purpose is to delay the approval of certain applications. Examples of such cases include:
• When the petitioner has taken an unreasonable length of time to submit the petition.
• Submission of multiple or serial petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions.
• Submission of a petition close to the approval date, such as close to the expiration of a blocking patent or exclusivity.
• Submission of a petition raising the same or substantially similar issues as a prior petition.
• Submission of a petition requesting that other applicants must meet standards for testing, data, or labelling for their products that are more onerous or rigorous than those of the originator.
Some lawmakers raised concerns during the open mark-up session about criteria FDA would use in assessing petitions. Representative Morgan Griffith worried that the legislation’s yardstick for abusive citizen petitions is too broad and could lead the agency to overlook legitimate scientific and regulatory issues. The current standard for denying a citizen petition looks for a primary purpose of delay and a lack of scientific basis, the proposed legislation does not require both criteria to be met.
Despite these concerns, however, the bill (HR 2387) was favourably forwarded to the full Committee, without amendment, by a voice vote.
FDA has already said that it will refer citizen petitions attempting to delay generics to the Federal Trade Commission (FTC) [1]. The agency also issued a Final Rule, which became effective on 9 January 2017, requiring that all citizens petitions or stays of action should include with their submission a verbatim certification statement specifying the date on which the information relied on in the petition first became known [2]. Then in October 2018, the agency released new draft guidance designed to limit the use of citizen petitions to delay the approval of generics and biosimilars [1].
Related articles
US Senators reveal plans to lower drug prices
A call to end US drug pricing games
Bipartisan bill aims to reduce healthcare costs in the US
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA to refer citizen petitions attempting to delay generics to FTC [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Guidelines/FDA-to-refer-citizen-petitions-attempting-to-delay-generics-to-FTC
2. GaBI Online - Generics and Biosimilars Initiative. FDA amends citizen petition rules to reduce delays to generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Policies-Legislation/FDA-amends-citizen-petition-rules-to-reduce-delays-to-generics-and-biosimilars
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: House Committee on Energy and Commerce
0
Post your comment