The Origins of “Confidential Commercial Information” at the FDA-Reference-Cited by-同舟云学术

The Origins of “Confidential Commercial Information” at the FDA

Published:2024-08-20 Issue:7 Volume:332 Page:533
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Daval C. Joseph Ross¹,Kesselheim Aaron S.¹

Affiliation:

1. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

Abstract

This Viewpoint reviews regulations regarding FDA’s handing of confidential commercial information, explains how these regulations serve as a barrier to disclosure of information in the interest of public health, and suggests how information could be carefully shared to improve health outcomes and advance research.

Publisher

American Medical Association (AMA)

Link

https://jamanetwork.com/journals/jama/articlepdf/2821289/jama_daval_2024_vp_240066_1723483047.11256.pdf

Reference7 articles.

1. Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study.;Lurie;BMJ,2015

2. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.;Kesselheim;Health Aff (Millwood),2007

3. Blueprint for transparency at the US Food and Drug Administration: recommendations to advance the development of safe and effective medical products.;Sharfstein;J Law Med Ethics,2017

4. The big data regulator, rebooted: why and how the FDA can and should disclose confidential data on prescription drugs and vaccines.;Morten;Calif Law Rev,2021

5. Litigating authority for the FDA.;Daval;Washington U Law Rev,2022