FDA Has "Cozy Relationship" With Pharmaceutical Companies, Says Adviser

By Kelly Burch 01/28/19

"The FDA has a lack of transparency. They use the advisory committees as cover,” said the head of the FDA’s opioid advisory council. 

member of FDA shaking hands with pharmaceutical company rep

A Food and Drug Administration adviser says that the agency is putting the needs of pharmaceutical companies above the public by continuing to approve dangerous pain medications. 

Speaking with The Guardian, Dr. Raeford Brown, head of the FDA’s opioid advisory council, said there are “cozy, cozy relationships between the pharmaceutical industry and various parts of the FDA.”

Brown has been vocally opposed to the approval of the drug Dsuvia, an opioid more powerful than fentanyl that the FDA recently approved against the recommendation of the advisory committee. (The FDA is not bound by the recommendation of the committee.)

Brown said that the committee voted to approve the drug while many committee members were away at a professional conference, which he believes was a willful manipulation of the system. 

“There’s no question in my mind right that they did that on purpose. The FDA has a lack of transparency. They use the advisory committees as cover,” Brown said. 

He pointed to Dsuvia’s approval as the latest sign that the FDA has allegiances to pharmaceutical companies. 

He said, “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. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”

This approach is fueling the rise in opioid-related deaths, he said. 

“They should stop considering any new opioid evaluation. 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.”

Brown pointed out that the FDA relies on pharmaceutical funding for 75% of the budget of the division that approves opioid medication. He explained that this allows pharmaceutical companies to unfairly influence the process, something that the FDA denies. Brown worries that despite the widespread deaths caused by the opioid epidemic and the resulting media coverage, little will change at the FDA.

“Nothing is fundamentally being done to effect change in the regulation of opioids,” he said. “If the FDA continues to encourage the pharmaceutical industry to turn out opioid after opioid after opioid, and the regulation of those opioids is no better than it was in 1995, then we’ll be cleaning this up for a long time.”

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.