The final, formatted version of the article will be published soon.
PERSPECTIVE article
Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 |
doi: 10.3389/fmed.2024.1475992
Conflicting interpretations and FDA reputation: The case of post-market surveillance of breast implants
Provisionally accepted- 1 Reichman University, Herzliya, Israel
- 2 Sheba Medical Center, Ramat Gan, Tel Aviv District, Israel
Conflicting interpretations regarding the severity of the adverse effects associated with FDA-approved drugs and therapies are common among the US Food and Drug Administration (FDA), the medical community, patients, and the general public. However, scholars have paid little attention to how these conflicting interpretations may affect the FDA's reputation for facilitating inclusive dialogue between competing policy actors. Focusing on breast implants, a medical device characterized by a stormy regulatory past, we observe that the design properties of post-market surveillance are adjusted to lowquality information. Such information-gathering mechanisms likely lead to underreporting by medical practitioners and the public, thus resulting in low-quality data. Given that the FDA cannot rely on congressional appropriations to ensure a stable flow of funding, the confusion and uncertainty created by conflicting interpretations enhance the FDA's ability to appeal to different audiences simultaneously and thereby secure funding from industry-based user fees. This strategy may persist until the FDA's reputation is challenged by critical information regarding adverse effects and the ensuing potentially negative media coverage. A stable appropriation-based funding model will likely encourage stronger post-market surveillance of medical devices.
Keywords: regulatory error1, voluntary recall2, underreporting3, under-design4, informed consent5, Risk communication6, medical devices7
Received: 09 Aug 2024; Accepted: 24 Oct 2024.
Copyright: © 2024 Maor and Shoenfeld. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Moshe Maor, Reichman University, Herzliya, Israel
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.