FDA plans ultra-fast review of three psychedelic drugs following Trump directive
Summary
The Food and Drug Administration (FDA) will speed up the review process for three psychedelic drugs aimed at treating mental health conditions like depression and PTSD. This move follows President Donald Trump’s executive order to make psychedelic drugs easier to access and regulate.Key Facts
- President Trump signed an order to speed access to psychedelic drugs and reduce restrictions on them.
- The FDA gave priority review vouchers to two companies developing psilocybin for tough-to-treat depression.
- Another company received a voucher for methylone, related to MDMA, targeting post-traumatic stress disorder (PTSD).
- Priority review means the FDA will try to shorten the review time from months to weeks.
- The FDA did not disclose the names of the companies receiving these vouchers.
- The FDA also allowed early testing of a drug related to ibogaine for treating alcohol use disorder.
- Ibogaine is a strong psychedelic with some known risks but is used by veterans to treat trauma and addiction.
- The fast-track review program has faced criticism for favoring companies linked to the White House.
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