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Protestors slam FDA with claims it did too little on opioids – STAT

WASHINGTON — Activists on Friday delivered a parting gift to Scott Gottlieb, the outgoing Food and Drug Administration commissioner, at the entrance of a federal building here: an 800-pound, supersized heroin spoon stamped with the FDA’s logo.

The group urged FDA to stop approving “dangerous” opioids and to instead encourage the development of more drugs to treat addiction. Many protesters decried the November approval of Dsuvia, a mega-potent pain drug, and urged the Trump administration to nominate an FDA commissioner who would take a different tack than Gottlieb on opioid approvals.

The protest comes after a series of demonstrations at museums funded by the Sackler family, the now-infamous founders of Purdue Pharma, the manufacturer of OxyContin. But Friday’s event, which took place just five blocks from the Arthur M. Sackler art gallery on the National Mall, marked a shift in protesters’ focus from the pharmaceutical industry to government.


The protesters numbered around 100. Though Homeland Security officers kept a watchful eye on the group, no arrests were made, even as protesters staged a lengthy “die-in” near the building’s entrance.

“When you are willing to overrule the objections of your expert advisory committees on opioids and rapidly push them out when you’ve got this climbing death rate, and yet you consistently slow-walk the medications to treat addiction, we have trouble,” said Carol McDaid, a lobbyist whose practice focuses on addiction and recovery issues and who attended the protest.

The protest took place at the HHS headquarters and not at FDA’s campus in Silver Spring, Md., because the space in front of those buildings is not accessible to unauthorized visitors, said Ryan Hampton, an activist and author who helped orchestrate Friday’s protest. In a speech, Hampton credited his recovery from addiction to medication-assisted treatment and said the FDA should work to spur treatments beyond the three currently available medications: naltrexone, buprenorphine, and methadone.

While it was an FDA-centric protest coinciding with Gottlieb’s final day on the job, Esposito said the action had been planned months before, prior to Gottlieb’s announcement he would leave the agency.

Sarah Peddicord, an FDA spokeswoman, said in a statement that the FDA “has been acting forcefully to address the crisis, which is the largest and most complex public health tragedy that our nation has ever faced.” She cited achievements that ranged from ensuring opioids are properly prescribed to prioritizing new forms of MAT to expanding naloxone availability.

Gottlieb made the opioid crisis one of the focuses of his nearly two-year tenure at the FDA, supporting efforts to sell the overdose-reversal drug naloxone over the counter, emphasizing the importance of medication-assisted treatment, and cracking down on illicit drug sales over the internet.

Controversially, he cracked down on the use of kratom, an unregulated herbal supplement that affects the same brain receptors as many opioids. While kratom is often used in nonmedical settings to treat pain or symptoms of opioid withdrawal, Gottlieb said FDA tests found unsafe levels of lead and nickel in numerous kratom samples, and said separate investigations found kratom companies marketing the drug for uses unvetted by medical literature.

The Dsuvia approval appeared to outweigh those accomplishments, however, especially after the head of an FDA advisory committee overseeing the approval process publicly protested the drug’s approval. In a letter, he predicted the drug would instantly lead to diversion and death following its approval. Despite those objections, the committee voted 10-3 to recommend Dsuvia’s approval.

But protesters said his actions were insufficient in the face of Dsuvia’s approval — and the agency’s ruling that Brixadi, a new addiction drug, could not be marketed in the U.S. until the exclusivity period for a similar product expires in late 2020.

The supersized sculpture of drug paraphernalia, complete with painted liquid heroin and burn marks on its bottom, is protest art manufactured by Domenic Esposito, a Boston-based sculptor whose brother has struggled with addiction. In a previous demonstration, Esposito left a spoon at the Connecticut headquarters of Purdue Pharma, the opioid manufacturer increasingly blamed for exacerbating the crisis.

“They need real investigations,” Esposito said of the FDA, alleging that the agency contributed to poor oversight of drug manufacturers and distributors who allowed rates of opioid prescription and diversion to spike in the past two decades.

Esposito, who drove from Massachusetts to D.C. on Thursday night with the sculpture in tow, said he’s manufactured four spoons to date: each cast from molten metal and emblazoned with a different logo, as appropriate.

He left the first at Purdue’s headquarters, and gifted another to Maura Healy, the Massachusetts attorney general who has aggressively investigated Purdue’s role in accelerating addiction deaths. A third came to Washington for Friday’s protest, and a fourth still is being prepared for a tour along the East Coast during which parents who have lost children to overdose can sign the spoon with their names.

The group’s chant, throughout the event: “Two hundred dead every day — we blame the FDA.”

Gottlieb told the Washington Post on Thursday that he will soon return to the American Enterprise Institute, a conservative think tank, as a resident fellow focused on prescription drug pricing.

Ned Sharpless, the director of the National Cancer Institute, will serve as acting FDA commissioner beginning next week. It is unclear whether President Trump is likely to nominate him to serve in the long term.

In his final days at FDA, Gottlieb sought to highlight much of the work the agency had done to curb the crisis, tweeting a letter from former FDA Commissioner Margaret Hamburg about a man whose son died from suicide after being able to obtain treatment for opioid addiction. FDA commissioners have passed pictures of the son, Michael, from one to the next since Hamburg’s tenure in 2015.

“Today,” Gottlieb wrote Tuesday on Twitter, “I gave it to Ned Sharpless.”