Re:Silicon Valley’s Ultimate Exit (2013)
by HarryHirsch on Thursday January 19, 2017 @10:50PM
(#13441614)
Here's a fun data point: people in the drug discovery business do not see the FDA as an obstacle to doing business. It's the financing model that's commonly seen as troublesome, with the low-hanging fruit gone coming distant second.
For genuine public health emergencies (anyone remember AIDS?) there's fast-track approval, the first antiretrovirals were at market remarkably quickly.
Re:Silicon Valley’s Ultimate Exit (2013)
by avn2109 on Thursday January 19, 2017 @11:44PM
(#13441774)
>> "...people in the drug discovery business do not see the FDA as an obstacle to doing business."
Let me play devil's advocate here and suggest that entrenched market participants love high-barrier-to-entry regulatory regimes. The FDA is "people in the drug discovery business'" moat.
Re:Silicon Valley’s Ultimate Exit (2013)
by HarryHirsch on Friday January 20, 2017 @08:23AM
(#13443589)
When you do drug discovery and development safety and efficacy is your concern. Your aims and the FDA's coincide. It's Pharma-Bro Shkreli who uses the FDA as a moat, but I think the general public sees him as an aberration and pharma wishes he would just go away because he draws the wrong kind of attention.
Re:Silicon Valley’s Ultimate Exit (2013)
by yummyfajitas on Thursday January 19, 2017 @11:46PM
(#13441786)
When cost comes down, financing becomes simpler, right?
Re:Silicon Valley’s Ultimate Exit (2013)
by HarryHirsch on Friday January 20, 2017 @08:19AM
(#13443562)
It's the risk that kills it. If your compound fails at late Stage 2 or early Stage 3 you just did 7 years for nothing. Also: the penguin effect. A first-in-class compound requires target validation, which adds another few years plus you can't patent that effort, and then the stuff arrives at market and physicians don't know why they should prescribe it. Just compare profit from the first statin to current 5th-generation profits from that same class. Silicon Valley is so much more predictable and offers returns in a shorter timeframe.
I'll agree with that, EU approval should prompt accelerated review. That said, thalidomide was far less bad in the US because the FDA was a little more conservative.
Still, I'd be willing to say EU approval should drop the cost in some way by reusing studies or other things.
However, that doesn't mean bad FDA rules are not also an issue. From the blog post I linked to:
Any pharma company that wants their medication approved in both the US and Europe has to spend a billion or so dollars getting it approved by the FDA, and then another billion or so dollars getting it approved by the Europeans. A lot of pharma companies don’t want to bother, with the end result that Europe has many good medications that America doesn’t, and vice versa. Just in my own field, amisulpride, one of the antipsychotics with the best safety/efficacy balance, has been used successfully in Europe for twenty years and is totally unavailable here despite a real need for better antipsychotic drugs.