approved stamp FDA

Protestors descended on the FDA today to mark the end of Scott Gottlieb’s tenure with the delivery of a large “heroin spoon” sculpture stamped with the FDA’s logo. Activists say they are angry that the outgoing commissioner rubber-stamped Dsuvia, an incredibly powerful opioid that is meant for surgeries and late-term terminal cancer.

The group of activists urged the FDA to stop approving “dangerous” opioids and to focus on more ideas for medication-assisted treatment and other drugs to help treat addiction.

Dsuvia is a sublingual formulation of sufentanil, which is 500 times as powerful as morphine. The drugmaker says that the drug was created for the management of acute pain in adults in medically supervised healthcare settings. Activists and addiction specialist believe that the drug will eventually make it onto the street, causing overdose deaths, just like fentanyl. Fentanyl was developed mostly for surgical settings but after a few years began to be prescribed off-label for chronic pain, causing addiction or dependence in its patients.

AcelRx Pharmaceuticals, says that the drug was created in collaboration with the Department of Defense to help meet the needs of the military population. In war settings and battlefields, soldiers don’t typically have access to intravenous (IV) treatments for pain. AcelRx says intramuscular injections (currently the standard of care for battlefield patients) are not as useful as IV options at providing timely relief, and may not be effective in cases of severe trauma. Because Dsuvia is sublingual, it can keep severely injured soldiers from going into shock, especially when a hospital setting could be hours away.

While it may be a good alternative for soldiers in wartime situations, the drug would be incredibly deadly if self-administered or sold on the street.

Protesters want to Trump administration to nominate an FDA commissioner who would take a hardline approach in response to the opioid crisis. They also want the government to take a defensive stance against new and possibly addictive opioid manufacturing.

The protest follows demonstrations at museums funded by the Sackler family. The Sacklers are the founders of Purdue Pharma, which manufactures of OxyContin, and is the focus of dozens of state, county, and local lawsuits across the US. The lawsuits claim Purdue marketed Oxycontin aggressively and minimized the addiction potential of the drug, despite the fact that Oxycontin is so addictive it used to be called “hillbilly heroin” on the street.