FDA Announces Midodrine Stakeholders Conference Call
The U.S. Food and Drug Administration (FDA) is holding a conference call on December 15, 2010 to discuss the data that is necessary to establish the efficacy of midodrine. Stakeholders are encouraged to participate to discuss information to share or a willingness to assist anyone planning to conduct clinical trials on midodrine.
In August the FDA proposed withdrawing approval of midodrine because required post-approval studies that verify the clinical benefit of the drug had not been done; the Society urged the agency to not remove the drug from the market and in October the FDA responded to the Society about its concerns.
Midodrine Stakeholders Teleconference details:
Wednesday, December 15
4:00 to 5:00 p.m. ET
Dial in number: +1 (888) 469-0501, passcode is FDA
Alternatively, you may dial +1 (517) 308-9236
The teleconference will be moderated by Heidi C. Marchand, PharmD, Office of Special Health Issues. The teleconference presentation will be by Norman Stockbridge, MD, Ph.D., Director, Division of Cardiovascular Renal Products, Center for Drug Evaluation and Research; Ellis Unger, MD, Deputy Director, Office of Drug Evaluation I and Robert Temple, MD, Deputy Center Director for Clinical Science.
Following the presentation, there will be a Question and Answer session. FDA experts will be available on the call to answer questions.
A replay of the teleconference will be available one hour after the call ends until February 15, 2011. To hear the replay, callers can dial toll-free +1 (888) 562-2793 or +1 (402) 998-1450.
Please see the announcement by FDA below for additional information on the call.
The Food and Drug Administration (FDA) invites healthcare professionals and key patient organizations to participate in a stakeholder teleconference to discuss the data that are necessary to establish the efficacy of midodrine. The purpose of this teleconference is to discuss whether you may have information to share or may be willing to assist anyone planning to conduct clinical trials on midodrine.
Since we notified the manufacturers of midodrine that FDA is proposing to withdraw approval of the drug, we have heard from professional organizations, doctors, and patients about their concern regarding the possible loss of access to midodrine. We are working with manufacturers of the medication to facilitate its continued availability, but, in the long run, continued access is contingent upon the demonstration of a clinical benefit.
Although there is much anecdotal support for the clinical benefit of midodrine, the body of evidence currently known to us does not meet the legal standard of substantial evidence of effectiveness. Therefore, we are reaching out to manufacturers, professional organizations, healthcare providers, and patient advocacy groups to determine if there are sources of data that we have not considered and, if not, to seek advice and assistance in developing the information necessary to support a conventional approval.
Information related to midodrine is available on FDA's FDA's website.
