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July 19, 2018
Gottlieb's biosimilar bark. But what about the bite?  
The FDA commissioner gave a tough speech on biosimilars yesterday at the Brookings Institution while unveiling an 11-point Biosimilars Action Plan.

Gottlieb decried PBMs (Trump administration health officials never seem to miss a chance to take a whack at PBMs) and "rebating schemes" in his prepared remarks. He criticized "patent thickets" that keep biosimilars off the market. And he gave the audience a bit of history lesson on pricing and reimbursement, saying it was designed when payers like Medicare were price takers that weren't in a position to negotiate prices because there was no competition among biologics

Gottlieb also told the Brookings audience that FDA would be teaming up with the FTC to challenge "gaming tactics" and anticompetitive behavior. 

Stay tuned, he said. And we and many others will be.

The action plan itself isn't a hugely revolutionary document. Might the bark here be more than the bite? The 11 points include moderate, sensible steps like standardizing review templates, enhancing the Purple Book, and giving developers additional guidance on interchangeability. 

Still, almost anything is going to be better than the current situation. The FDA has approved a paltry number of biosimilars--just 11, Gottlieb said in his speech--and only three are on the market. 
No shelter from the storm for PBMs
And there's the possibility of more bad news for PBMs. 

Bloomberg reported yesterday that HHS submitted a proposal to the White House late Wednesday that would tighten up the anti-kickback law that currently give PBMs a "safe harbor" to use the discount and rebating practices that they've thrived on. 

No details have come out. But the Bloomberg story had a link to an OMB website posting, and the title for pending regulatory review says quite a lot: " Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection." 

HHS Secreatary Alex Azar hasn't been shy about criticizing PBMs and their business practices. In testimony before a Senate committee last month, Azar mooted getting away from rebating and fixed-price contracts.

"Such a system's incentives, detached from these artificial list prices, would likely serve patients far better, as would a system where PBMs receive no compensation from the very pharma companies that they are supposed to be negotiating against," Azar told the senators.

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Azar asks Gottlieb to study drug importation
This is clearly the week that the publicity-conscious (to put it mildly) Trump administration wanted some conversation about its efforts to lower drug prices. 

On Thursday, Azar announced that he was asking Gottlieb to establish a working group on drug importation. Gottlieb has expressed reservations about drug importation in the past--including in a 2016 interview with Managed Care.

The creation of a working group is hardly a formula for dramatic action. Besides, the press release talks about studying drug importation in cases when a manufacturer that is in a monopoly position suddenly raises prices, and it gives the Martin Shkreli drug, Daraprim, as an example (although it doesn't name Shkreli.) 

Azar doesn't seem to be contemplating opening the door broadly to drug importation but using it in special cases. 

ECRI to turn the lights back after AHRQ guideline website goes dark
There was an uproar--and a Twitter hashtag, #Savetheguidelines--when AHRQ's National Guideline Clearinghouse went dark on Monday. Atul Gawande was among those who sounded the alarm.  

Budget cuts were the reason. Republicans have had a target pinned on AHRQ's back for quite awhile and the shuttering the guideline website was a jab at AHRQ. 

But the ERCI Institute in suburban Philadelphia, which has had a contract with AHRQ to maintain the guideline website, said this week that it would revive the website and launch an interim version this fall. One big difference, though: ECRI says it is going to need to charge some kind of fee. 
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