The Promising Pathway Act

The evident failures of the FDA and CDC during COVID have opened up new opportunities for reform. One of the most interesting is the Promising Pathway Act, sponsored by Sens. Mike Braun (R-Ind.) and Kirsten Gillibrand (D-N.Y.). As Bart Madden and I write, the Act would create a new form of approval, provisional approval.

The Hill: Here’s how the current version of the bill works: A new drug could secure provisional approval for serious or life-threatening health conditions via early-stage clinical investigations indicating that the new drug’s safety and efficacy compare favorably to approved drugs.

Importantly, provisional approval requires establishing patient registries for all such treatments and is not simply a matter of faster approval. Third-party, independent entities would manage these registries, tracking safety and effectiveness.

In order to speed up the use of this new knowledge, the de-identified, disaggregated databases would be accessible to approved researchers, medical professionals for public health research and biopharmaceutical industry researchers. Drug sponsors or the government would fund the registries, and the FDA would submit an annual report to Congress on provisionally approved drugs.

Thus, provisional approval would allow earlier access to not yet approved drugs but would require the creation of a patient registry and database that could be used by anyone to evaluate the drug. An interesting and important idea.

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