5 ms·
"Mr. Hasler said this was probably not done because foreign manufacturers were not willing to bear the expense of applying for regulatory approval in the United
by toddbranch 11y ago
"Mr. Hasler said this was probably not done because foreign manufacturers were not willing to bear the expense of applying for regulatory approval in the United States to serve a tiny number of patients."
Or we could reduce the burden of applying for approval?
- Scoundreller 11y agoI agree. My blood isn't any different than a Europeans' or an Americans', so why duplicate the approval process? It can't be unsafe for one and safe for another just because some imaginary line has been crossed. It would also help to reduce drug shortages if stock could be more easily transferred.
- refurb 11y agoso why duplicate the approval process? It was the separate approval process that prevented an explosion of thalidomide babies in the US.[1] [1]http://en.wikipedia.org/wiki/Thalidomide#Birth_defects_crisis http://en.wikipedia.org/wiki/Thalidomide#Birth_defects_crisi...
- Scoundreller 11y agoIt could also be argued that one process would have prevented the explosions everywhere.
- neurotech1 11y agoThere is actually a FDA "waiver" process known as a "Humanitarian Device Exemption" for medical devices. The FDA does allow compounding pharmacies [0] to produce orphan drugs that are not otherwise available commercially. The big issue with using compounding pharmacies to produce orphan drugs is that these drugs can't be marketed for a specific use. The approval is as much about how the drug is marketed as the drug itself. The reason why the case of Daraprim [1] is so outrageous is that the drug is approved and in production, and the increase is profit for the "marketing" drug company. [0] https://en.wikipedia.org/wiki/Compounding#Regulation_in_the_United_States https://en.wikipedia.org/wiki/Compounding#Regulation_in_the_... [1] https://en.wikipedia.org/wiki/Pyrimethamine https://en.wikipedia.org/wiki/Pyrimethamine