February 23, 2011, Vol 305, No. 8 >

< Previous Article

Full Content is available to subscribers

Subscribe/Learn More

Next Article >

Letters | February 23, 2011

Withdrawing FDA Approval of Midodrine After Marketing—Reply

Sanket S. Dhruva, MD; Rita F. Redberg, MD, MSc

JAMA. 2011;305(8):781-782. doi:10.1001/jama.2011.162.

Text Size: A A A

Published online

Article

References

Extract

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 In addition, drugs whose requisite studies are not completed should be withdrawn in a timely manner to prevent the companies from continuing to earn profits on unproven therapies.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.

Sign In to Access Full Content

Username

Password

Forgot Your Password?

Don't have Access?

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large

Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

References

Letters

Submit a Letter

February 23, 2011

Withdrawing FDA Approval of Midodrine After Marketing

Neil A. Holtzman, MD, MPH; Barbara Starfield, MD, MPH

JAMA. 2011;305(8):781-782. doi:10.1001/jama.2011.161.

CME

Accreditation Information

The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit^TM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 Credit^TM.

Note: You must get at least of the answers correct to pass this quiz.

Clear Answers | Save For Later

You have not filled in all the answers to complete this quiz

The following questions were not answered:

Sorry, you have unsuccessfully completed this CME quiz with a score of

The following questions were not answered correctly:

Commitment to Change (optional):

Indicate what change(s) you will implement in your practice, if any, based on this CME course.

Your quiz results:

The filled radio buttons indicate your responses. The preferred responses are highlighted

For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes

Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s “Cited By” API will populate this tab (http://www.crossref.org/citedby.html).

Compression-Only CPR: Pushing the Science Forward
Cone
AAM 2010;304:1493-1495.

All you need to read in the other general journals
BMJ 2010;341:c5893-c1494.

Instructions

Thank you for submitting a comment on this article. It will be reviewed by JAMA editors. You will be notified when your comment has been published. Comments should not exceed 500 words of text and 10 references.

Do not submit personal medical questions or information that could identify a specific patient, questions about a particular case, or general inquiries to an author. Only content that has not been published, posted, or submitted elsewhere should be submitted. By submitting this Comment, you and any coauthors transfer copyright to the journal if your Comment is posted.

* = Required Field

Response Author(s)* (if multiple authors, separate names by comma)

Example: John Doe

Affiliation & Institution*

Disclosure of Any Conflicts of Interest* Indicate all relevant conflicts of interest of each author below, including all relevant financial interests, activities, and relationships within the past 3 years including, but not limited to, employment, affiliation, grants or funding, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. If all authors have none, check "No potential conflicts or relevant financial interests" in the box below. Please also indicate any funding received in support of this work. The information will be posted with your response.

Please disclose any conflicts of interest or check the box below.

No potential conflicts or relevant financial interests

Response Title*

Response*

Get Audio Code

Submit Cancel

Submit a Response

Some tools below are only available to our subscribers or users with an online account.

Print
PDF
Email

AMA

You must be logged in and have an account to share content.

Return to: Withdrawing FDA Approval of Midodrine After Marketing—Reply

This feature is provided as a courtesy. By using it you agree that that you are requesting the material solely for personal, non-commercial use, and that it is subject to the AMA's Terms of Use. The information provided in order to email this article will not be shared, sold, traded, exchanged, or rented. Please refer to The JAMA Network's Privacy Policy for additional information.

© 2013 American Medical Association. All Rights Reserved.
Share
Get Citation

Dhruva SS, Redberg RF. Withdrawing FDA Approval of Midodrine After Marketing—Reply. JAMA. 2011;305(8):781-782. doi:10.1001/jama.2011.162.

Download citation file:

RIS (Zotero)

EndNote

BibTex

Medlars

ProCite

RefWorks

Reference Manager

© American Medical Association
Get Permissions
Get Alerts

Processing your request... Please Wait.
Submit a Letter

Sign In to Access Full Content

Username

Password

Forgot Your Password?

Full Content is available to subscribers

Withdrawing FDA Approval of Midodrine After Marketing—Reply

Extract

Sign In to Access Full Content

Don't have Access?

First Page Preview

Figures

Tables

Interactive Graphics

Video

References

Letters

Sign In

Don't have Access?

Sign In to Access Full Content

Related Content

JAMA

Content

Services

The JAMA Network

Sites

AMA Publishing Group Journals

Information For

Services

Content Resources

Other Resources

Sign In

Register for a FREE personal account

Want to Subscribe?

Don't have Access?

Forgot Your Password?