Head of opioid advisory panel criticises FDA for complacency in ongoing crisis

pharmafile | January 28, 2019 | News story | Medical Communications, Sales and Marketing Dsuvia, FDA, opioid crisis, opioids, pharma 

The opioid crisis continues to be a top healthcare concern in the US, but the head of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has called out the drug regulator over its handling of the epidemic.

In an interview with The Guardian, Dr Raeford Brown accused the FDA of complacency in its continued approval of opioid pain medications, in light of a lawsuit against OxyContin manufacturer Purdue Pharma which alleges that the company’s owners, the Sackler family, were personally responsible for directing deceptive sales tactics and peddling deliberate misinformation in order to boost sales, fully aware but without concern for the damage the drug would cause.

“I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens,” Dr Brown said. “Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a wilful blindness that borders on the criminal.”

Dr Brown pointed particularly to the FDA’s approval of Dsuvia last year, a form of opioid-based painkiller which can be up to ten times more potent than fentanyl.

The US opioid epidemic has claimed nearly 400,000 lives between 1999 and 2017, according to the Centers for Disease Control (CDC), with 47,000 dying in the latter year alone, with 36% of these deaths caused by prescription drugs. Today, opioids are responsible for around 150 deaths per day.

“They should stop considering any new opioid evaluation,” Dr Brown added. “For every day and every week and every month that the FDA don’t do the right thing, people drop dead on the streets. What they do has a direct impact on the mortality rate from opioids in this country.”

Matt Fellows

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