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Sep-05-2016 14:54printcomments

Douglas Throckmorton, MD, Deputy Director of FDA - I expect an apology!

I participated in a "stakeholders" teleconference with Dr. Throckmorton to discuss the "FDA's strongest box warning on opioids". Or, did I?

Douglas Throckmorton
Douglas Throckmorton, M.D.
Image: fda.gov

(MYRTLE BEACH, S.C.) - On August 31 (with 45 minutes) notice, I was asked to participate in a "stakeholders" teleconference with Douglas Throckmorton, M.D., Deputy Director for regulatory programs in FDA’s Center for Drug Evaluation and Research (CDER) to discuss the "FDA's strongest box warning on opioids".

One of Dr. Throckmorton's responsibilities at the FDA is ensuring that the benefits of approved drugs outweigh their known risks.

I found it interesting that I was considered a "stakeholder" by the FDA and invited to be part of this teleconference and wondered what the definition of a "stakeholder" is in the eyes of the FDA.

This right off their website:

All key stakeholders including consumer organizations, researchers, scientists, and industry representatives are invited to participate in these stakeholder meetings.

Interesting the day before the FDA held a "media" teleconference on this subject. When I called in for the "stakeholder" teleconference, I was asked my name and title. I indicated I was an "investigative reporter".

I was prompted to hit "1" if I had a question before Dr. Throckmorton read from his prepared text. I hit "1" realizing my chances of Dr. Throckmorton acknowledging me were quite slim. Never say never.

After Throckmorton's alerting stakeholders to the FDA's concern about strong warnings for opioid analgesics, prescription opioid cough products, and benzodiaepine labeling related to serious risks and death from combined use, I was called on for my question to Dr. Throckmorton.

I began by reminding Dr. Throckmorton that I have been writing about the prescription opioid epidemic for 14 years which is worsening every day and I questioned if the FDA worked for pharma or was protecting the American people.

Then I said -- "So far this year you have approved 7 or 8 extended release opioids -- when is enough enough? You have sat back while 26,000 people died this year alone."

My response to challenging Dr. Throckmorton was a voice saying the teleconference was over and I was disconnected. Later I listened to a playback of the teleconference and it did not end with me being hung up on, two more "stakeholder" calls were taken. One was from Canada and one from the EPA.

I will be at the FDA hearings on September 15 and 16 while the FDA discusses "guidelines for children being prescribed opioids." If that does not scare you it should. (See below).

Since the FDA has sat back and approved prescription opioids in record numbers (more than any other country in the world), we can anticipate children being used as pawns by the FDA as they are fed opioids by pharma.

So, yes, Dr. Throckmorton, I expect an apology from you while I am sitting listening to "pharma scientific experts" promote opioids to children with the FDA anticipating the financial rewards.

Oh, and the apology won't be just to me, but to the 26,000 families who have lost loved ones to the prescription opioid epidemic you and pharma have worked in partnership to rage out of control.

I ask you again Dr. Throckmorton "when is enough enough?"

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Advisory Committee Meeting: Anesthetic and Analgesic , the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee Date: September 15, 2016, 8:00 am to 5:00 pm Date: September 16, 2016, 8:00 am to 5:00 pm Location: FDA White Oak Campus - 10903 New Hampshire Ave, Silver Spring, MD. 20993 Agenda: The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

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