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Top FDA official says the agency is bowing to Big Pharma

The Food and Drug Administration is succumbing to Big Pharma’s influence to keep approving lucrative opioids despite the toll they’re taking on American lives, a top official at the agency claims.

Dr Raeford Brown, chair of the FDA’s committee for reviewing opioid approvals, told the Guardian the agency is having a ‘direct impact on the mortality rate from opioids in this country’ by continuing to approve new high-risk drugs.

His words come after the FDA approved a controversial new opioid, Dsuvia, despite its own board of physicians warning the drug is easy to abuse and could cause more deaths.

Dr Brown was one of a number of committee members who, he claims, we deliberately barred from voting on Dsuvia because the in-person vote was scheduled for the same day as a conference that most of them were attending. 

The drug’s manufacturers and the FDA claim that, since the drug will mainly be administered by doctors in hospital settings, there is a low risk of it reaching the streets. 

But Dr Brown warns sufentanil is already known to be abused by doctors and having hospitals as the gatekeeper is no sure-fire way to prevent it reaching the black market.   

The FDA approved a dissolvable pill form of sufentanil, a potent opioid that will be placed under the tongues of patients in pain in hospitals – despite outcry from many doctors

Sufentanil, a cousin of fentanyl, was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.

But now it will be available as a single, dissolvable dose for patients in the hospital, at just $50 to $60 a tablet.

The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor.

The tablet, placed under the tongue with a dispenser, starts reducing pain in 15 to 30 minutes. 

Gottlieb noted the pill was a high priority for the Department of Defense, which helped fund testing, because it wanted a way to provide fast pain relief to injured soldiers.

In a lengthy statement, FDA Commissioner Scott Gottlieb said there will be ‘very tight restrictions’ placed on its distribution and it is intended only for supervised settings like hospitals. 

It will carry a boxed warning and won’t be available at drugstores for patients to take home. 

Instead, doctors will administer a single dose under the tongues of patients in pain in hospital settings. 

But Dr Brown worries that isn’t enough control over the drug. 

He predicts that the pill will be abused inside and outside medical settings and cause overdose deaths. 

‘Because the drug is used in a sublingual’ – or under the tongue – ‘form, it will be rapidly absorbed by the vasulature under the tongue,’ Dr Brown told in an interview in October, shortly after members of his committee voted 10-3 in favor of Dsuvia. 

Dr Brown couldn’t attend the meeting and didn’t cast a vote because he was already scheduled to speak at the annual meeting of the American Society of Anesthesiologists at that time, attended by about 10 other committee members, by his estimation.     

Today he reiterated to the Guardian that he believes the scheduling was deliberate. 

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

The vote is not binding, it is just a vote of confidence. But the FDA has tended to heed their advice. 

But Dr Brown says that has gradually been changing, driven by ‘cozy, cozy relationships between the pharmaceutical industry and various parts of the FDA.’ 

He added that AcxelRX’s assurances that their drug’s design will keep it from being abused shouldn’t carry much weight. 

‘Just because a company says, ‘we’re only going to allow the drug to be used in way X’ doesn’t mean it’s true,’ said Dr Brown.

‘I learned that the hard way.’

The FDA’s promises during the drug’s review process didn’t inspire much confidence in Dr Brown, either. 

‘[The FDA] has put together a program that hasn’t thus far found any reliable risk mitigation strategy that is effective in preventing misuse and diversion of these agents,’ he said.  

He has asked FDA staff to ‘evaluate a new framework’ for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.

‘We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval – the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction,’ Gottlieb wrote.