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Scott Gottlieb has a lot of thoughts on CBD
When I chatted with the former FDA commissioner about the agency’s efforts to regulate CBD, one thing was crystal clear: Gottlieb probably isn’t going to be offered a job as the head of the CBD lobby any time soon.
“There’s no science to demonstrate that putting it in the food supply has any medicinal value, let alone [to] support that it’s safe. People are just doing it,” Gottlieb told me.
Our chat came just after I published a story about the FDA’s quest (or perhaps, its struggle) to regulate CBD, or cannabidiol, in dietary supplements.
Gottlieb, like any good (former) regulator, also emphasized that he believes there’s likely a “pharmaceutical opportunity here,” and listed neurological and neuromuscular disorders as two potential conditions that pharmaceutical CBD might be shown effective to treat.
And CBD supplement lovers, don’t panic just yet: Gottlieb also made it about as clear as he could that the FDA is likely to figure out a way to allow some level of CBD in supplements, so long as research doesn’t show low levels of CBD are dangerous.
Gottlieb was also largely unapologetic about the laissez-faire approach to CBD that the FDA took during his tenure, despite widespread criticism. “I thought the agency was pretty proactive here. I feel pretty good about how we stepped into this,” he told me. More of my conversation with Gottlieb is here.
By the way, Gottlieb wasn’t the only one with #feelings after my story dropped. Dr. Amy Abernethy, the FDA’s principal deputy commissioner and head of the FDA’s CBD working group, came out with a curiously themed tweetstorm on CBD after my story published. I see you, Dr. Abernethy!
We aren’t still arguing about transparency, are we?
The Energy and Commerce Committee will hold a hearing on a handful of drug pricing bills today. The majority of the bills deal with transparency, which I like to call “the most contentious issue that no one except Washington lobbyists argue about.” It’s unclear how fiery (or boring, quite frankly) today’s hearing will be.
The witnesses, which include representatives from the drug lobby PhRMA and their middlemen counterparts, PCMA, are likely to disagree about how Congress should tackle transparency — and drug pricing writ large — but I was struck by how muted their prepared testimonies were.
Kristin Bass, who heads up policy for PCMA, for example, is likely to show only muted opposition to a bill from Rep. Abigail Spanberger (D-Va.) that would require PBMs to report their aggregate rebates and discounts to a public website. The industry has long fought against forced disclosure of its rebate information, arguing it could hamper their ability to negotiate substantial discounts. But instead of coming out with full throated opposition, Bass says the group “generally support[s]” reporting aggregate rebates, with the caveat that there’s a carve-out for drugs with less than three competitors.
Nevertheless, the hearing is the latest example of the House legislating in earnest on drug pricing. The House passed its first tranche of drug pricing bills last week, but not without some head-scratching drama (a STAT headline was even schlepped onto the House floor by Republican Michael Burgess of Texas!). ICYMI, check out my colleague Lev Facher’s juicy story from last week.
Gilead isn’t out of the doghouse yet
The House Oversight Committee’s hearing last week on Gilead’s Truvada isn’t likely to be the end of it’s investigation into the high price of that pre-exposure prophylaxis (PrEP) drug, which is used to prevent the transmission of HIV.
“The committee plans to do more with this, including potential requests to Gilead,” a senior Democratic committee aide told me Friday.
That’s a vague comment, but things could get really interesting if it means Chairman Elijah Cummings (D-Md.) is going to start requesting documents from Gilead. Cummings and his staff can do much more harm to a company’s reputation through an extensive investigation into internal documents than even the most contentious hearing.
Cummings, along with Rep. Alexandria Ocasio-Cortez (D-N.Y.) already sent a request last week to HHS Secretary Alex Azar requesting a slew of information centered on the government’s decision not to enforce its patents on Truvada. They also asked about Gilead’s recent decision to donate 2.4 million bottles of the drug, following public outcry over its price.
But one thing’s for sure: If Cummings digs any deeper, he’s going to invite pushback from the committee’s Republican ranking member, Rep. Jim Jordan of Ohio, who made no bones about the fact he wasn’t on board for last week’s hearing. If you missed it, check out my colleague Ed Silverman’s dispatch from that day.