FDA Responds to AbleChild’s MedWatch PSA Request for Public Education

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Recently, AbleChild requested that the FDA run their own PSA (Public Service Announcement) to educate the public on how to report Adverse Drug Reactions directly to the Agency.  The FDA’s response to our request is shocking, as they state that because MedWatch is a “voluntary” program, there is no need to run the PSA to educate the people on its existence and importance.

As more and more drugs hit the market with the approval of the FDA, the risk of dangerous and deadly side effects increase.  By not informing the public on the importance of reporting adverse side effects through MedWatch, the FDA is directly thwarting its ethical duty to protect the health and well-being of each citizen.  There is a clear lack of awareness on MedWatch and its role.   It is irresponsible for the FDA to not heed AbleChild’s request and promote its own program that they specifically implemented, originally, as a safety measure.

Their own PSA, created in 2016 and hasn’t been aired since, says, twenty cents of every dollars interacts with approved FDA products.  How much of that dollar goes into consumer awareness?  Not one cent.  Why?

Shame on an Agency that clearly doesn’t have the public interest at heart.


CDER DRUG INFO

Thu, Apr 23, 4:50 PM

Dear Sheila Matthews,

Thank you for writing to Jeremy Kahn. Please accept this response, by the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research, on his behalf.

We greatly appreciate your effort in contacting the FDA and sharing your thoughts on the MedWatch program with us. We value your comments and have duly noted them.

We provide the user-friendly MedWatch Online Voluntary Reporting Form for healthcare professionals and consumers/patients to report their side effects to us. The MedWatch reporting program is a voluntary system of reporting any product quality issues and/or drug adverse effects to the FDA.  To learn more about our MedWatch program, we invite the public to visit our website at What Happens When a Problem is Reported?.

Thank you again for discussing this very important matter with us.

Best Regards,

Kim
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov

This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.


Sent: Wednesday, April 22, 2020 10:23 AM
Subject: MEDWATCH MINUTE REQUEST

Dear Jeremy Kahn,

AbleChild is a nonprofit organization.  Our mission is informed consent.  It is with urgency, we ask that the FDA start running on TV, Radio, and Printed media the 2016 MedWatch Minute in response to this National Crisis.  It a violation of human rights not to educate the public on this critical MedWatch safety program developed for the consumer to report adverse drug events to the FDA.

As you know the MedWatch program is critical and vital for the FDA to receive Adverse Drug Events from the public.

We appreciate your consideration and look forward to your response.  Please don’t tell us it is not your job.  As you know, massive amounts of new drugs are being “fast tracked” it is about time you “fast track” the critical MedWatch information.  Below is your PSA.

https://www.ablechild.org/2020/04/06/fdas-medwatch-minute-where-has-it-been/

Please respond to our inquiry and request.

Thank you,

Sheila Matthews
Cofounder AbleChild.org

Adverse Drug Event, Clinical Drug Trials, Drug Evaluaton, Drug Research, FDA, Jeremy Kahn, MedWatch

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