FDA's Continuing Arrogance and Indifference to the Opioid Epidemic as Death Toll Rages!

Sufentanil should never be approved for human use.

Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at FDA

(MYRTLE BEACH, SC) - The FDA has announced a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee for October 12. I am extremely interested in this meeting where a very dangerous opioid named Sufentanil will be discussed by the Advisory Committee and I plan to attend.

Sufentanil (R30730 brand name Sufenta) is a synthetic opioid analgesic drug approximately 5 to 10 times more potent than its parent drug, Fentanyl, and 500 times as potent as morphine -- with high risk of addiction.

It will make OxyContin look like a day at the beach if approved. Sufentanil sublingual will be off-label marketed as dangerous opioids such as OxyContin were allowed to be and could be administered to women in labor with a caution to the attending physician of the risks of respiration failure or death.

Sufentanil should never be approved for human use.

I sent an email to eleven (11) high ranking officials at the FDA incorporating the above paragraph and asking their assurance that this very vital Advisory Committee meeting will be web broadcasted in its entirety.

I also asked who will be serving on the Advisory Committee and who their "experts" are giving testimony to the need and safety of Sufentanil.

In my seventeen (17) years of communicating with the FDA regarding the approval of opioids by their agency and the resulting epidemic, this is the first time that I did not receive a reply from them. Concerning? You bet it is.

October 12 Agenda

The committee will be asked to discuss new drug application (NDA) 209128, Sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting.

The committee will also be asked to discuss risk-benefit considerations and whether this product should be approved.

So let me ask the arrogant and indifferent officials at the FDA this question:

Are you aware that we are losing people in the hundreds of thousands to deaths and addictions because of the number of opioids you continue to approve?

A couple of years ago, I asked Douglas Throckmorton, MD Deputy Center Director for Regulatory Programs, CDER, FDA on a telephone conference call "Doug how many opioids will you continue to approve before you realize we have enough?"

I was left with a dial tone in my ear.

Maybe the words "arrogance" and "indifference" are not harsh enough to be used in describing the FDA. I will be working on stepping things up in describing the callousness the FDA has shown the American people as deaths mount to opioids and the FDA increases approval of opioids.

I repeat "Sufentanil should never be approved for human use" -- and the FDA knows it.

Links to previous articles written by me exposing Janet Woodcock, MD for her part in contributing to the opioid epidemic:

• Douglas Throckmorton, MD, Deputy Director of FDA – I expect an apology!
• Is Janet Woodcock, MD, Director of FDA guilty of medical malpractice?
• U.S. Senators are Outraged by FDA Approving OxyContin for Children!