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Withdrawing FDA Approval of Midodrine After Marketing—Reply

Withdrawing FDA Approval of Midodrine After Marketing—Reply In Reply: The call by Drs Holtzman and Starfield to impose financial penalties on companies that fail to adhere to their agreement to perform postmarketing trials is very reasonable. Midodrine generated more than $250 million in sales over a 13-year period,1 none of which was spent to conduct the clinical trials that the sponsor was bound to perform. Their suggestion to have sponsors literally pay for reneging on their obligations to the FDA and to patients taking the medication makes sense. In addition, drugs whose requisite studies are not completed should be withdrawn in a timely manner to prevent the companies from continuing to earn profits on unproven therapies. Fourteen years, and several warning letters from the FDA to midodrine's sponsors, is far too long. We fully agree that there must be increased transparency at the FDA. The public deserves to know which companies are violating their postmarketing requirements by not completing required clinical trials. But transparency must be even more extensive. The public, including both health professionals and patients, must know what data the FDA reviews in making its approval decisions as well as the sponsors' obligations that come with approval. To achieve this end, we support the proposals to facilitate complete access to FDA reviews.2,3 Furthermore, these reviews must be readable and include FDA reviewers' uncertainties during the approval process, in addition to the information about required postapproval studies on which the approval is conditional.4 Given that the sponsor and the FDA form binding agreements, we believe that it is the duty of the sponsor—not health professionals or patients—to conduct appropriate clinical trials that demonstrate a drug's benefits outweigh its risks. Companies must be actively held to deadlines for postmarketing studies. Dr Margaret A. Hamburg, the FDA commissioner, has asked for increased funding, as she feels that some of the FDA's responsibilities outstrip its resources.5 We support increased funding for the FDA so it has the necessary resources and political support to hold companies accountable for postmarketing data requirements and can act decisively when deadlines are not met. Back to top Article Information Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Redberg reported being a member of the FDA Circulatory System Devices Panel and a member of the California Technology Assessment Forum. Dr Dhruva reported no disclosures. Disclaimer: Dr Redberg is Editor, Archives of Internal Medicine. References 1. New drug approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints [GAO-09-866 September 23, 2009]. US Government Accountability Office. http://www.gao.gov/products/GAO-09-866. Accessed December 23, 2010 2. O’Connor AB. The need for improved access to FDA reviews. JAMA. 2009;302(2):191-19319584349PubMedGoogle ScholarCrossref 3. Miller JD. Registering clinical trial results: the next step. JAMA. 2010;303(8):773-77420179288PubMedGoogle ScholarCrossref 4. Schwartz LM, Woloshin S. Lost in transmission: FDA drug information that never reaches clinicians. N Engl J Med. 2009;361(18):1717-172019846841PubMedGoogle ScholarCrossref 5. Okie S. Reviving the FDA. N Engl J Med. 2010;363(16):1492-149420925536PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Withdrawing FDA Approval of Midodrine After Marketing—Reply

JAMA , Volume 305 (8) – Feb 23, 2011

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References (5)

Publisher
American Medical Association
Copyright
Copyright © 2011 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2011.162
Publisher site
See Article on Publisher Site

Abstract

In Reply: The call by Drs Holtzman and Starfield to impose financial penalties on companies that fail to adhere to their agreement to perform postmarketing trials is very reasonable. Midodrine generated more than $250 million in sales over a 13-year period,1 none of which was spent to conduct the clinical trials that the sponsor was bound to perform. Their suggestion to have sponsors literally pay for reneging on their obligations to the FDA and to patients taking the medication makes sense. In addition, drugs whose requisite studies are not completed should be withdrawn in a timely manner to prevent the companies from continuing to earn profits on unproven therapies. Fourteen years, and several warning letters from the FDA to midodrine's sponsors, is far too long. We fully agree that there must be increased transparency at the FDA. The public deserves to know which companies are violating their postmarketing requirements by not completing required clinical trials. But transparency must be even more extensive. The public, including both health professionals and patients, must know what data the FDA reviews in making its approval decisions as well as the sponsors' obligations that come with approval. To achieve this end, we support the proposals to facilitate complete access to FDA reviews.2,3 Furthermore, these reviews must be readable and include FDA reviewers' uncertainties during the approval process, in addition to the information about required postapproval studies on which the approval is conditional.4 Given that the sponsor and the FDA form binding agreements, we believe that it is the duty of the sponsor—not health professionals or patients—to conduct appropriate clinical trials that demonstrate a drug's benefits outweigh its risks. Companies must be actively held to deadlines for postmarketing studies. Dr Margaret A. Hamburg, the FDA commissioner, has asked for increased funding, as she feels that some of the FDA's responsibilities outstrip its resources.5 We support increased funding for the FDA so it has the necessary resources and political support to hold companies accountable for postmarketing data requirements and can act decisively when deadlines are not met. Back to top Article Information Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Redberg reported being a member of the FDA Circulatory System Devices Panel and a member of the California Technology Assessment Forum. Dr Dhruva reported no disclosures. Disclaimer: Dr Redberg is Editor, Archives of Internal Medicine. References 1. New drug approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints [GAO-09-866 September 23, 2009]. US Government Accountability Office. http://www.gao.gov/products/GAO-09-866. Accessed December 23, 2010 2. O’Connor AB. The need for improved access to FDA reviews. JAMA. 2009;302(2):191-19319584349PubMedGoogle ScholarCrossref 3. Miller JD. Registering clinical trial results: the next step. JAMA. 2010;303(8):773-77420179288PubMedGoogle ScholarCrossref 4. Schwartz LM, Woloshin S. Lost in transmission: FDA drug information that never reaches clinicians. N Engl J Med. 2009;361(18):1717-172019846841PubMedGoogle ScholarCrossref 5. Okie S. Reviving the FDA. N Engl J Med. 2010;363(16):1492-149420925536PubMedGoogle ScholarCrossref

Journal

JAMAAmerican Medical Association

Published: Feb 23, 2011

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