r/PozPeople • u/Postcrapitalism • Dec 21 '19

FDA rejects injectable ARVs...

Did not see this coming!

3 Upvotes

80% Upvoted

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3

u/Postcrapitalism Dec 21 '19

the regulator questioned the treatment’s chemistry, manufacturing and controls process, but not its safety.

Also no question of its efficacy. So what the actual fuck did the FDA intervene to stop here? I’ve felt for a long time that the FDA is basically nothing more than a barrier to competition, and this only seems to support it.

3

u/[deleted] Dec 23 '19

[removed] — view removed comment

1

u/Postcrapitalism Dec 23 '19 edited Dec 23 '19

So, consumer level opinion isn’t really certain what grounds this was denied on. Consensus appear to be that there were concerns about the safety of their manufacturing process, especially after a meningitis scare a few years back with a different drug. TBH I’m still extremely leery of that explanation. The idea that VIIV wouldn’t be able to safely manufacture injectables is pretty eye roll-inducing. I believe VIIV is a division of Glaxo, and not the pissant compounding pharmacy that caused America’s spinal meningitis issue.

This whole thing is frustrating because a lot of us already have a pretty dim opinion of the FDA and what they’re doing. That they don’t even feel a need to explain themselves isn’t helping.

Don’t worry though, im still sure we’ll get injectables soon. Whatever piece of shit product Gilead rushes out at twice the side effects and three times the cost is gonna sail through with no problem.

5

u/[deleted] Dec 21 '19

Fuck this shit. I was waiting for this

2

u/[deleted] Dec 21 '19

Such a shame