Treffer: AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.

Title:
AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.
Authors:
Takefuji Y; Faculty of Data Science, Musashino University, 3-3-3 Ariake Koto-Ku, Tokyo, 135-8181, Japan. takefuji@keio.jp.
Source:
The AAPS journal [AAPS J] 2025 Feb 20; Vol. 27 (2), pp. 48. Date of Electronic Publication: 2025 Feb 20.
Publication Type:
Journal Article
Language:
English
Journal Info:
Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Imprint Name(s):
Original Publication: Arlington, Va., USA : American Association of Pharmaceutical Scientists, [2004]-
References:
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Rathore AS, Li Y, Chhabra H, Lohiya A. FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010–2020. J Pharm Innov. 2022;1–10. Advance online publication. https://doi.org/10.1007/s12247-022-09678-2 .
Ciulla M, Marinelli L, Di Biase G, Cacciatore I, Santoleri F, Costantini A, Dimmito MP, Di Stefano A. Healthcare systems across Europe and the US: the managed entry agreements experience. Healthcare (Basel, Switzerland). 2023;11(3):447. https://doi.org/10.3390/healthcare11030447 . (PMID: 10.3390/healthcare1103044736767022)
Van Norman GA. Off-label use vs off-label marketing of drugs: part 1: off-label use-patient harms and prescriber responsibilities. JACC Basic Transl Sci. 2023;8(2):224–33. https://doi.org/10.1016/j.jacbts.2022.12.011 . (PMID: 10.1016/j.jacbts.2022.12.011369086739998554)
FDA.GOV. Drug Approval Process. 2023. https://www.fda.gov/media/82381/download . Accessed 7 Feb 2025.
FDA.GOV. New Drug Application (NDA). 2023. https://www.fda.gov/drugs/types-applications/new-drug-application-nda . Accessed 7 Feb 2025.
Zettler PJ, Shah SK. Broader implications of eliminating FDA jurisdiction over execution drugs. Am J Public Health. 2021;111(10):1764–7. https://doi.org/10.2105/AJPH.2021.306425 . (PMID: 10.2105/AJPH.2021.306425344735358561201)
Contributed Indexing:
Keywords: FDA approval; generative AI; market date; marketing drug in the US; python code generation
Entry Date(s):
Date Created: 20250220 Date Completed: 20250509 Latest Revision: 20250828
Update Code:
20250828
DOI:
10.1208/s12248-025-01039-4
PMID:
39979651
Database:
MEDLINE

Weitere Informationen

This paper explores a novel approach using generative AI to enhance drug marketing strategies in the US pharmaceutical sector. By leveraging an official dataset sourced from the US government, the AI generates Python code to analyze the time interval between FDA approval dates and market release dates. The analysis identifies 370 manufacturers who achieved "zero-day" marketing-referring to drugs marketed immediately upon FDA approval-and 174 manufacturers who marketed their products within less than seven days of approval. Notably, 947 drug products were found to have been marketed prior to FDA approval, raising significant regulatory and ethical concerns that necessitate further discussion. The findings indicate that 174 drug manufacturers have the potential to optimize their marketing strategies to achieve zero-day timelines, prompting an examination of the feasibility of such acceleration within the current regulatory framework and its implications for industry practices. Additionally, this paper discusses the broader impact of AI-driven strategies in the pharmaceutical sector, highlighting their potential to not only enhance marketing speed but also improve aspects such as compliance and decision-making efficiency. Furthermore, a tutorial on implementing generative AI is provided, detailing how it can be utilized to achieve marketing objectives through interactive conversations with the AI. This practical application demonstrates the technology's capabilities using real dataset analysis and reveals significant findings that could inform future strategies within the industry. The research objectives and their broader implications underscore the need for ongoing dialogue about the ethical and regulatory dimensions of AI in pharmaceutical marketing.
(© 2025. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)

Declarations. Competing Interests: The author has no conflict of interest.