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Montana delegates experimental medical approvals to private board

Business Insider reports that Montana's right-to-try law lets a venture capitalist's private board approve uncleared treatments.

The short version

  • Montana's right-to-try legislation relies on a privately operated review board to approve experimental medical treatments outside FDA oversight.[Business Insider]
  • The board, created with involvement from biotech investor Niklas Anzinger, approved a hearing loss therapy combining sound therapy and an off-label drug.[Business Insider]
  • Patients currently cannot access approved treatments because state officials have not yet licensed any experimental treatment centers.[Business Insider]
  • Medical ethicists warn the private approval model risks conflicts of interest, while proponents cite lower costs compared to federal clinical trials.[Business Insider]

Key facts

  • Montana uses a privately operated five-member review board run by Niklas Anzinger's company to decide which unapproved experimental treatments to authorize.[Business Insider]
  • The legislation behind the system was drafted with help from state Senator Kenneth Bogner, the Alliance for Longevity Initiatives, and Anzinger.[Business Insider]
  • Anzinger's review board charges medical companies a $12,500 application fee to seek approval in Montana.[Business Insider]
  • The board authorized its first therapy, combining an antihistamine and sound therapy for hearing loss.[Business Insider]

What remains uncertain

  • It remains unknown when patients will receive authorized therapies, as Montana has not licensed any experimental treatment centers.[Business Insider]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.