FDA Speeds Drug Trials; Montana Expands Experimental Access — SkimNews
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- The FDA opened applications for a pilot program to shorten the time drugmakers need to begin testing products in humans, building a network of "qualified research institutions" to partner with companies on Investigational New Drug application packages.
- Operation TrialBlazer, the HHS initiative housing the pilot, was first announced in June and pledged to shorten FDA drug approval timelines to help the U.S. compete with biotechnology industries in China and Australia.
- Libertarian-fringe biotech investors helped draft a Montana state law last year expanding access to drugs that no regulator has deemed safe and effective.
- Montana is now relying on a privately run board to decide which experimental treatments to offer, raising concerns about conflicts of interest and whether patients will get value for their money in an industry rife with unfounded claims.
- The company managing the Montana program works with biotech firms in a zone off the coast of Honduras with no drug regulator, and startup biotech firms hope Montana will serve as their shortcut around the FDA's costly drug development process.
Why it matters: Operation TrialBlazer targets the early-testing phase the HHS pledged to shorten so the U.S. can compete with China's biotech sector, while Montana's privately governed pathway offers a parallel route for experimental treatments outside the FDA's costly review process.
Ask SkimNews
