I, for one, am decidedly skeptical that Scott Gottlieb, and the new FDA/HHS leadership will actually be able to achieve what each is setting out to do, despite all the tough talk on pricing from the White House. Even so, most major pharma names have seen NYSE declines this week -- even in the face of some very positive oncology drug press coverage.
The issue is pricing -- and the new FDA leader's remarks to the effect that he will make a priority of bringing at least three generic competitors to market, for each formerly branded drug, when the relevant patent exclusivity lapses. There is significant empirical evidence that drug prices fall precipitously when a third competitor enters a given market. And so, that is his aspirational goal. It is also his goal to clear the generic app. backlog, at FDA. But that one will likely require a very large budget bump -- one that the White House (let alone Congress) -- will be unlikely to push through, in the current environment.
As I say though, the NYSE stock ticker for most names is showing more than a little concern, here (a bit, from Bloomberg, then):
. . . .FDA Commissioner Scott Gottlieb said in an interview Monday that the agency is looking at how to push applications to the front of the line in cases where there are fewer than three competing generic manufacturers. The policy would target cases where there are few or no competing versions of drugs, which has led to high prices in some situations. . . .
Adding generic competitors would mean lower prices, Gottlieb said. The goal is to have three manufacturers of every generic version of a drug. That’s the point at which prices start to fall significantly, he said. . . .
The agency is also looking at a plan to eliminate within a year the backlog of 2,640 generic-drug applications. . . .
The FDA is also looking into whether it can publish a list of the 180 brand-name drugs that no longer have patent protection and still don’t face any generic competition, 150 of which the agency has never received an application from a generic drugmaker to review.
Publishing it “might create a more compelling business opportunity,” he said.
Many of these ideas will be discussed at a public hearing the FDA plans to hold in the next several months to discuss ways to facilitate generic-drug competition. . . .
Now you know -- feeling cold, on an otherwise sunny day. A bit of a collateral family medical emergency. May be off-line until Monday, now. Be good to one another.
[In more encouraging news, Cassini has completed its eighth inner ring dive, safely overnight.]
नमस्ते
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