Last week, I interviewed FDA Commissioner Dr. Robert Califf for MedPage Today and Inside Medicine. The edited videos (slightly abridged) are available at Medpage (Part I and Part II) and the full unabridged audio and transcript are below. In addition to potentially making a little bit of news in our interview (which I’ll get to in a moment), we also learned that Dr. Califf has been an active
Great interview thanks for sharing! And a special thanks for working in my suggested Narcan going OTC question 💪 I think the commissioner’s answer was a little shaky… I agree we probably won’t see $700 price tags like Epinephrine… but the similarities do exist as life saving treatments that can be exploited for profiteering. And the FDA should be more aware of the powers they actually have!
See second article below about these powers.
2 quotes to consider in case the commissioner reads your comments section a week later 😉
NYT: last month:
Narcan’s manufacturer, Emergent BioSolutions, declined to disclose the price plans for an over-the-counter version, pending F.D.A. approval. The company said it would “work with public interest” groups, who are now charging about $47.50 a box. Health economists predict the new price could land somewhere between $35 and $65 — plus a retailer’s markup.
So the cost of the new out-of-pocket Narcan could make the spray prohibitive for many individuals, especially for those who inject opioids, and, indirectly, for the organizations that buy the medication in bulk.
“People who really need it won’t be able to afford it, so it is much more likely that it becomes an item that is shoplifted,” said Jim Thacker, who directs the Target4 Project, a statewide program based at the University of Kentucky that focuses on H.I.V. prevention and gives out free Narcan.
And that, he said, may create another obstacle: “Then Narcan will probably be put behind the pharmacist’s counter or behind glass, which creates a barrier to the people who can afford it but don’t want to ask for it,” he said.
*and from a 2021 article in The Gaurdian;
Naloxone is an inexpensive medication that’s been around since the 1970s. Other life-saving medications such as insulin and EpiPens are also sold at prohibitively high costs.
“This is a symptom of broader dysfunction in the US pharmaceutical industry, where public health concerns are secondary to financial concerns,” Beletsky said.
But “it’s not enough to criticize the pharmaceutical industry,” he added. “We should be using the regulatory tools that we have to compel them to act in a different way.”
The federal government could step in to make the prices more affordable and consistent, “but that just hasn’t happened yet”, Latimore said.
Because there are no gaps in supply – only in price – the US Food and Drug Administration hasn’t declared a naloxone shortage.
One solution could be creating public benefit corporations – organizations that produce essential medications for low prices. Such a corporation was proposed in the Purdue Pharma settlement, Beletsky pointed out. The Biden administration could also invoke the Defense Production Act to compel private entities to prioritize manufacturing naloxone under the rationale that the opioid epidemic is a national crisis.
So let’s hope there’s a good balance between serving a societal need and paying the stockholders! Lord knows the epipen phenomenon is inexcusable, and actually quite evil.
Great interview thanks for sharing! And a special thanks for working in my suggested Narcan going OTC question 💪 I think the commissioner’s answer was a little shaky… I agree we probably won’t see $700 price tags like Epinephrine… but the similarities do exist as life saving treatments that can be exploited for profiteering. And the FDA should be more aware of the powers they actually have!
See second article below about these powers.
2 quotes to consider in case the commissioner reads your comments section a week later 😉
NYT: last month:
Narcan’s manufacturer, Emergent BioSolutions, declined to disclose the price plans for an over-the-counter version, pending F.D.A. approval. The company said it would “work with public interest” groups, who are now charging about $47.50 a box. Health economists predict the new price could land somewhere between $35 and $65 — plus a retailer’s markup.
So the cost of the new out-of-pocket Narcan could make the spray prohibitive for many individuals, especially for those who inject opioids, and, indirectly, for the organizations that buy the medication in bulk.
“People who really need it won’t be able to afford it, so it is much more likely that it becomes an item that is shoplifted,” said Jim Thacker, who directs the Target4 Project, a statewide program based at the University of Kentucky that focuses on H.I.V. prevention and gives out free Narcan.
And that, he said, may create another obstacle: “Then Narcan will probably be put behind the pharmacist’s counter or behind glass, which creates a barrier to the people who can afford it but don’t want to ask for it,” he said.
*and from a 2021 article in The Gaurdian;
Naloxone is an inexpensive medication that’s been around since the 1970s. Other life-saving medications such as insulin and EpiPens are also sold at prohibitively high costs.
“This is a symptom of broader dysfunction in the US pharmaceutical industry, where public health concerns are secondary to financial concerns,” Beletsky said.
But “it’s not enough to criticize the pharmaceutical industry,” he added. “We should be using the regulatory tools that we have to compel them to act in a different way.”
The federal government could step in to make the prices more affordable and consistent, “but that just hasn’t happened yet”, Latimore said.
Because there are no gaps in supply – only in price – the US Food and Drug Administration hasn’t declared a naloxone shortage.
One solution could be creating public benefit corporations – organizations that produce essential medications for low prices. Such a corporation was proposed in the Purdue Pharma settlement, Beletsky pointed out. The Biden administration could also invoke the Defense Production Act to compel private entities to prioritize manufacturing naloxone under the rationale that the opioid epidemic is a national crisis.
So let’s hope there’s a good balance between serving a societal need and paying the stockholders! Lord knows the epipen phenomenon is inexcusable, and actually quite evil.
And PS - FDA should use these sorts of powers for mife.