4 ms·

There was a good article on this in the New Yorker a while back: https://www.newyorker.com/magazine/2023/06/26/relyvrio-als-fda-approval https://www.newyorker.c

There was a good article on this in the New Yorker a while back: https://www.newyorker.com/magazine/2023/06/26/relyvrio-als-fda-approval https://www.newyorker.com/magazine/2023/06/26/relyvrio-als-f... It's sad that the drug didn't work (and I had a cousin recently die of ALS), but it's important to let the FDA do their work.

thenerdhead 3y ago
What work does the FDA do here? It is the work of large investments or initiatives to prove safety and efficacy and the FDA makes decisions. If anything we live in a world where we need better provisions for these illnesses similar to https://www.congress.gov/bill/118th-congress/senate-bill/1906/titles?s=1&r=44 https://www.congress.gov/bill/118th-congress/senate-bill/190... Waiting for phased trials when you understand the research and hypothetical risks is torture. Especially when many drugs have proven safety profiles where the only harm is financial.
- ProjectArcturis 3y ago
  This particular drug was just a combination of two already-approved generic drugs. Anyone could have tried them with a doctor's Rx without a change in the law.
  - thenerdhead 3y ago
    Ah so a patent company who wanted to make a profit? https://www.regulations.gov/docket/FDA-2023-E-2605 https://www.regulations.gov/docket/FDA-2023-E-2605 Interesting!
    - downvotetruth 3y ago
      Infuriating that government site does not even display without JavaScript.
hash872 3y ago
>but it's important to let the FDA do their work The FDA has been 'working' on authorizing sunscreen widely used in the rest of the developed world for the last 20 years, or since the original Dubya administration. This is not a typo. They are glacially, bureaucratically slow & cautious
- Auracle 3y ago
  Isn’t the real problem on that from that no company will put up funds to do the trials since they aren’t patentable at this point? That said, I feel like there should absolutely be an almost automatic approval for stuff sold in multiple other countries for decades.

thenerdhead 3y ago

What work does the FDA do here? It is the work of large investments or initiatives to prove safety and efficacy and the FDA makes decisions. If anything we live in a world where we need better provisions for these illnesses similar to https://www.congress.gov/bill/118th-congress/senate-bill/1906/titles?s=1&r=44 https://www.congress.gov/bill/118th-congress/senate-bill/190... Waiting for phased trials when you understand the research and hypothetical risks is torture. Especially when many drugs have proven safety profiles where the only harm is financial.

ProjectArcturis 3y ago
This particular drug was just a combination of two already-approved generic drugs. Anyone could have tried them with a doctor's Rx without a change in the law.
- thenerdhead 3y ago
  Ah so a patent company who wanted to make a profit? https://www.regulations.gov/docket/FDA-2023-E-2605 https://www.regulations.gov/docket/FDA-2023-E-2605 Interesting!
  - downvotetruth 3y ago
    Infuriating that government site does not even display without JavaScript.

hash872 3y ago

>but it's important to let the FDA do their work The FDA has been 'working' on authorizing sunscreen widely used in the rest of the developed world for the last 20 years, or since the original Dubya administration. This is not a typo. They are glacially, bureaucratically slow & cautious

Auracle 3y ago
Isn’t the real problem on that from that no company will put up funds to do the trials since they aren’t patentable at this point? That said, I feel like there should absolutely be an almost automatic approval for stuff sold in multiple other countries for decades.