3 ms·
There should be a step between banning and approval. If you look at the history of hiv/aids drug approval it's pretty clear that there is significant harm that
by shkkmo 5y ago
There should be a step between banning and approval.
If you look at the history of hiv/aids drug approval it's pretty clear that there is significant harm that can be done by banning unapproved drugs.
At the same time, removing the requirement to show efficacy to be approved is also quite obviously bad for the reasons outlined in the article.
Why can't the company be allowed to provisionally sell the drug with the warning that the FDA has evaluated the drug as "unproven efficacy" until such a time as the follow up studies are completed?
- ceejayoz 5y agoWe have such a thing. https://www.fda.gov/news-events/public-health-focus/expanded-access https://www.fda.gov/news-events/public-health-focus/expanded...
- shkkmo 5y agoMy understanding is that while that helps in some cases, the restrictions on its applicability leave a lot of people high and dry.
- EamonnMR 5y agoThey could sell them as supplements but then they wouldn't be legally able to claim efficacy or be billed as medicine. They can't make nearly as much money without FDA approval.