PDUFA VI: FDA could promote generics competition

Home/Policies & Legislation | Posted 29/07/2022 post-comment0 Post your comment

In the US, the current Prescription Drug User Fee Act (PDUFA) is due to expire in September 2022. A recent report calls for the new iteration of the act (VI) to increase Food and Drug Administration’s (FDA) authority to promote generic competition [1].

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The Brookings Institution’s report has highlighted some concerns within FDA’s current regulatory processes. Specifically, these relate to three measures to promote improved generic drug competition: the Citizen Petition mechanism; the approval of ‘complex generic drugs’; and generic drug ‘parking’.

Citizen Petitions
Under these [2], petitioners can ask FDA to reject or delay new drugs as additional review is ‘necessary to protect the public health’. However, it is clear to the report authors that these petitions are generally used by companies to delay competition and maintain market position. The authors suggest to ‘Strengthen the FDA’s authority to dismiss petitions and penalize non-meritorious filers by instituting time limits and associated penalties’, and ‘improve the transparency of the FDA’s review of citizen petitions by requiring the agency to report more details about delays and the agency’s review process’.

Complex generics
Complex generics are small molecule non-biological drugs that have difficulty establishing bioequivalence. The report highlights that an issue facing complex generics is related to the FDA guidance on drug-device combinations, also known as the ‘sameness standard’ and transparency. It suggests that the sameness standard be relaxed from substantial equivalence to functional equivalence on drug-device combinations. In addition, a streamlined review of ingredients for injectable complex generics could be introduced and the report highlighted some potential legislative options for which FDA could supply further clarification.

Generic Drug Parking
This is a practice whereby the companies who are the first to apply for FDA approval with a generic candidate pause at the tentative approval stage. The report notes that some reasons for this ‘parking’ are justified but not all. To prevent unjustified parking, the report authors suggest amendment to provisions surrounding the existing, 180-day exclusivity reward for patent challenges. They state that this should be changed ‘to specify a presumption that any patent litigation settlement between generic and brand firms that do not allow for immediate generic drug entry be viewed as grounds for forfeiture of the generic’s 180-day exclusivity period’. The report authors noted that this may encourage first-filing generics firms to enter because delaying entry means a loss of exclusivity. The authors also suggest creating additional financial incentives to encourage ‘at-risk launching’ by the first generic drug filer and the creation of a Government Accountability Office to examine options.

The previous solution to generic drug parking was the BLOCKING Act that would allow FDA to approve generic drugs from rival competitors who were not the first before the agency if certain conditions were met, however, the report notes that the success of this has been brought into question.

A vote to reauthorize fees was recently passed in the House of Representatives, but it is yet to pass in the Senate [3].

Related articles
US Senate clarifies status of interchangeable biosimilar exclusivity

Biosimilar User Fee Act reauthorization

FDA to hold public meeting on its user fee programmes

Application fees increase for prescription drugs


The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View last week’s headline article: Perspectiva de la regulación de biosimilares en América Latina para mejorar el acceso al tratamiento del cáncer

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Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de de la semana pasada: Perspectiva de la regulación de biosimilares en América Latina para mejorar el acceso al tratamiento del cáncer

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


1. Sachs R, Wosińska M, Frank RG, et al. The FDA could do more to promote generic competition: here’s how. Brookings. 14 June 2022.
2. GaBI Online - Generics and Biosimilars Initiative. Bill to stop misuse of Citizen Petitions advances in the House [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 29]. Available from: www.gabionline.net/policies-legislation/Bill-to-stop-misuse-of-Citizen-Petitions-advances-in-the-House
3. GaBI Online - Generics and Biosimilars Initiative. House bill passes FDA funding fees but conflicts with Senate bill [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 29]. Available from: www.gabionline.net/policies-legislation/house-bill-passes-fda-funding-fees-but-conflicts-with-senate-bill

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