Although US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb admits that ‘FDA doesn’t control drug pricing’, he points to the fact that FDA ‘policies do affect competition in the market’. With this in mind he announced on 2 October 2017 ‘a major new set of policies’ aimed at making it easier to bring generic competition to complex drugs.
FDA defines complex products as including products with complex active ingredients, formulations, routes of delivery or dosage forms; complex drug-device combination products; and other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.
Earlier in 2017, the agency announced its Drug Competition Action Plan [1], which aims to advance new policies aimed at bringing more competition to the drug market. As part of this plan FDA has now announced new policies that aim to ensure that the agency provides as much scientific and regulatory clarity as possible with respect to complex generics.
The agency is therefore ‘taking a number of new steps to support the development of high quality ANDAs for complex generic drugs’. These include:
1. Issuing draft guidance to assist abbreviated new drug application (ANDA) applicants and prospective ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors looking to develop complex generic drugs.
Formal meetings between FDA and ANDA applicants of complex products under GDUFA
Date: October 2017
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578366.pdf
2. Issuing draft guidance to help applicants determine when submission of ANDAs for certain complex products, known as peptides, would be appropriate.
ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin
Date: October 2017
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578365.pdf
3. FDA’s generic drug regulatory science programme is also working to identify gaps in the science and develop more tools, methods, and efficient alternatives to clinical endpoint testing, where feasible. To help with this task, the agency is holding a series of important scientific workshops that will identify opportunities for complex generics development, discuss quantitative modelling approaches and principles and aid product-specific guidance development.
The agency has previously announced that it would set up a specific abbreviated pathway for complex products so that they would not have to follow the generic drug pathway [2].
This latest announcement comes as part of a wider effort by FDA ‘to address the high and rising cost of drugs’ [3]. Dr Gottlieb concludes that ‘drug access is a matter of public health concern’. He adds that ‘enabling more generic competition, where Congress intended, helps reduce prices, enable more access, and improve public health’.
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References
1.GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition
2. GaBI Online - Generics and Biosimilars Initiative. FDA to set up abbreviated pathway for complex products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/Polices-Legislation/FDA-to-set-up-abbreviated-pathway-for-complex-products
3. GaBI Online - Generics and Biosimilars Initiative. FDA targets rising drug prices by increasing generics competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Generics/General/FDA-targets-rising-drug-prices-by-increasing-generics-competition
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