Live4Lali Responds to FDA’s Decision to Approve Dsuvia

U.S. Food & Drug Administration (FDA) Approves Dsuvia (sufentanil), a drug 1,000 times stronger than morphine for medical use

The FDA’s decision has been met with a lot of criticism due to the addiction and overdose crisis we currently face. We decided to take action by sending FDA Commissioner Scott Gottlieb a letter voicing our concerns and requesting he and the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) reconsider this decision. This is completely unnecessary and poses great risk as the FDA has little to no control over how a drug is marketed beyond approval.

Our Response

November 6, 2018
Scott Gottlieb, MD
Commissioner
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Gottlieb:

We are a patient advocacy group working with individuals and families impacted by the addiction and overdose crisis in Illinois. The hundreds of people we serve are battling or are in recovery from a substance use disorder and dual diagnoses in addition to chronic pain. On a daily basis, we see the astronomical impacts created by the unnecessary over-availability of high-potency pain medications, and street-bought synthetic products, many of which contain fentanyl or its analogs.

 
We were disturbed by the recent decision of the U.S.Food & Drug Administration to approve Dsuvia, made by AcelRx, for use in medical centers. AcelRx’s viewpoint that Dsuvia will not be dispersed to patients through pharmacies and thus won’t pose a threat to the millions of people dependent on opioids or suffering from an opioid use disorder is reprehensible and naive. It is a well-known fact that once a drug emerges into the marketplace, the FDA has no control over its distribution. For example, transmucosal fentanyl was initially only intended for patients with cancer pain. However, it has become widely distributed among patients with substance use disorders. We also recall certain statements made by Purdue Pharmaceuticals in the late 1990s when they promoted that their product, Oxycontin, was unlikely to cause addiction. With 72,000 people dead from overdoses in 2017, it’s pretty clear that they were wrong and millions of families have paid the price for their irresponsibility.

There are more than enough formulations of opioid analgesics in the medical community, in oral, parenteral and transdermal formulations. To add another that is 1,000 times stronger than morphine is nothing short of irresponsible. Instead of pushing out a dangerous medication like sufentanilin the middle of a crisis that has been barely contained, we encourage the FDA to focus on approving and fast-tracking drugs and other treatments to prevent opioid dependency or opioid use disorders, such as alternatives to opioids (NSAIDS). We also encourage a focus on researching and approving new medication-assisted treatment formularies for substance use disorder types without presently approved treatments such as amphetamine use disorder, and on new, lower cost formularies of naloxone for layperson use.

If the strategy of the administration centers on prevention, treatment, and recovery, we are confused by this abrupt decision, which is out of alignment with that emphasis. Also, according to the U.S. Food & Drug Administration website , “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” This decision is counterproductive to that very statement and poses grave concerns to communities like ours fighting to pull ourselves out of this crisis at the local level.

In closing, we disagree with your decision to approve Dsuvia and ask that you consider the potential destruction and devastation its access can cause. We also have concerns that this decision prioritizes the profitability of pharmaceutical companies and in turn, the administration who will receive payouts from the pharmaceutical lobby in future elections. Patient care, public safety, and medical necessity need to come first, and not profits or payoffs.

Sincerely,

Chelsea Laliberte, MSSA
Executive Director, Live4Lali
Direct: 844.584.5254 x802
Email: [email protected]

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This post was written by live4lali