“a war” within the FDA as officials in charge of opioid policy have “failed to learn the lessons” of the epidemic

1-24-19    Dr Raeford Brown told the Guardian there is “a war” within the FDA as officials in charge of opioid policy have “failed to learn the lessons” of the epidemic that has killed hundreds of thousands of people over the past 20 years and continues to claim about 150 lives a day.

Brown accused the agency of putting the interests of narcotics manufacturers ahead of public health, most recently by approving a “terrible drug”, Dsuvia, in a process he alleged was manipulated.

“They should stop considering any new opioid evaluation,” said Brown. “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, an anesthesiologist who chairs the FDA committee of specialists advising the agency on whether to approve new opioid painkillers, said he no longer had confidence in repeated assurances by the FDA leadership that it was taking the epidemic seriously and prepared to put public health above the commercial interests of drug makers.

US regions where drug companies marketed hit hardest by opioids crisis

 

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

Brown’s comments echo criticisms by US senators who have condemned the FDA for what they say is its “complicity” in the epidemic, for approving the powerful painkillers that drove the crisis and then failing to use its powers to protect the public as the death toll escalated.

Four US senators wrote to the head of the FDA, Dr Scott Gottlieb, late last year urging him not to allow Dsuvia, a powerful opioid pill, on to the market because it was “to the detriment of public health”.

Dsuvia is a branded narcotic sufentanil pill, a more potent version of fentanyl, made by Californian pharmaceutical company AcelRx.  The signatories included Senator Joe Manchin of West Virginia, whose state has the highest rate of opioid overdose deaths in the country.   https://www.theguardian.com/us-news/2019/jan/24/fda-opioids-big-pharma-prescriptions

-Food and Drug Administration Commissioner Scott Gottlieb

  "We may find a niche for [Dsuvia] but it's not like we need it, and for sure, at some level, it's going to be diverted," says Dr. Palmer MacKie, assistant professor at the Indiana University School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis. "Do we really want an opportunity to divert another medicine?" 

Though the advisory committee ultimately voted in favor of the drug, Public Citizen contends the FDA sought to "tilt" the vote's outcome toward approval.  Brown, the committee chief, who has been outspoken against certain opioids in the past, says he was unable to attend the advisory committee meeting on Oct. 12 because of a scheduling conflict that he had informed the FDA about months in advance.  Brown says the FDA decided to hold the meeting anyway — without him. 

"I have strong feelings about the opioid crisis, as someone who lives in the Commonwealth of Kentucky, where we continue to have people die," Brown says.  "My forthright nature may have played a role in their decision about how the agency was going to manage this advisory committee."   The October meeting also left out most members of another FDA committee — the Drug Safety and Risk Management Advisory Committee — who are often included in regulatory discussions of new opioid drugs.  Public Citizen says members of that committee were not invited to attend.  http://health.wusf.usf.edu/post/despite-warnings-fda-approves-potent-new-opioid-painkiller#stream/0

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11-2-18  In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a “danger” to public health.  And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids.  https://www.scientificamerican.com/article/fda-approves-controversial-new-opioid-10-times-more-powerful-than-fentanyl/

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