Ibogaine; authorize SDH to select a consortium to conduct a drug development clinical trial with, to secure FDA's approval of.
What changed between versions
A new definition of 'lead consortium' is added in Section 2(f), meaning the consortium first established by the government of another state. This creates a designated primary actor in the multi-state ibogaine effort.
Section 3(a) now requires that the drug developer in Mississippi's consortium 'shall be the same drug developer that is part of the lead consortium,' tying Mississippi's effort to a specific existing out-of-state entity rather than allowing independent selection.
The old Section 8 required Mississippi's selected consortium to independently submit an IND application to the FDA and seek breakthrough therapy designation. This requirement is entirely removed in the new version.
Section 8 is retitled from 'Investigational new drug application' to 'Agreement with lead consortium.' The Mississippi consortium must now enter into an agreement with the lead consortium after that lead consortium has submitted the IND and sought breakthrough therapy designation, rather than doing so itself.
Section 5(2)(d) changes from requiring 'a detailed plan to seek a breakthrough therapy designation' to 'a plan to coordinate with the lead consortium to seek a breakthrough therapy designation,' shifting Mississippi from an independent actor to a coordinating partner.
Coordination requirements in Section 8(2) now specify coordination with trials 'conducted by the lead consortium and in other states' rather than simply 'in other states,' further anchoring Mississippi's role to the lead consortium's activities.