The chairman of a Food and Drug Administration advisory committee on the approval of new opioids says the agency is bowing to the influence of big pharmaceutical companies who want new powerful new opioids, and ignoring the danger of the drugs to Americans, 72,000 of whom died of overdose in 2017.
Anesthesiologist Raeford Brown told the Guardian that a war is now raging within the FDA over the agency’s policies and practices when reviewing and approving painkillers. Some are pushing for tougher approval guidelines for opioids, while others believe that big drug companies should be granted the chance to bring new drugs to market. Brown says the FDA has failed to learn from its own mistakes, and continues to ignore the abuse risks of new drugs.
“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. 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,” Brown told the Guardian. “The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
Trump-appointed FDA chief Dr. Scott Gottlieb said the agency should consider not only the effectiveness of a new opioid, but the need for the drug. He promised “dramatic action” to overhaul the agency’s methods, but the recent approval of another powerful painkiller called Dsuvia has called that pledge into serious doubt.
The FDA approved Oxycontin, the powerful narcotic pill that set off the opioid epidemic, in 1995 without clinical trials. The drug’s maker, Purdue Pharmaceuticals, convinced the FDA–and then doctors–that the drug was safe for widespread use in treating less-than-severe pain. The FDA then approved Fentanyl in 1998.
Dsuvia, which is a more potent version of Fentanyl that comes in pill form, was developed by the California pharmaceutical company AcelRx in cooperation with the U.S. Department of Defense. In 2017, the FDA rejected the drug on the advice of an advisory committee, the Guardian reports, but when the company resubmitted the drug a year later it was approved. And members of the advisory board who had pointed out the drug’s potential for abuse, including Brown, were not invited to the approval proceedings the second time around.
The most alarming part of the Guardian report is the idea that a crucial aspect of the FDA–the part that protects patients from harm from dangerous opioids–has effectively been privatized. A legal change in the 1990s allowed for more industry funding, and now the FDA division that approves new opioid drugs receives 75% of its funding from the industry. This, critics suggest, puts the FDA in the posture of a business partner of Big Pharma rather than a regulator.
A government survey in 2016 suggested that around 2.1 million Americans have abused opioids. That’s likely a conservative estimate given the stigma around admitting such a problem to a stranger. On average, more than 200 Americans died of opioid overdose every day in 2017.
The Guardian story says that the FDA denies that the pharma industry’s funding of the approval process gives it undue influence. The agency didn’t immediately respond to our request for comment on the report.