Thread by @_jacquie_lee

THREAD: today Trump & Hahn talked about the FDA's "compassionate use" pathway to get patients unapproved #Covid_19 treatments

In 2018 Trump supported a similar law, #RightToTry, but comments today on reporting/data needs highlight its pitfalls (1/6)

news.bloomberglaw.com/health-law-and…

Both FDA expanded access (or compassionate use) and Right to Try let patients access experimental drugs

But RTT has less robust reporting & cuts FDA completely out of the administration process (2/6)

Under FDA pathway, agency gets a 'written summary of the results of the expanded access use, including adverse effects' (per FDA)

Under RTT: an annual report of more general info & "serious adverse events" (per law)

Hahn wants that detailed data (3/6)

So that's why expanded access is being encouraged instead of RTT when it comes to giving patients experimental #Covid_19 treatments
Hahn wants to use the results of those treatments in those patients to better understand our options for coronavirus (4/6)

Other groups say Right to Try is the answer to help with speedy #Covid_19 treatments

The Goldwater Institute pushed for 'expanding' RTT earlier this week (not sure what that entails bc state RTT laws & a federal law exist already)

Few reports of patients using RTT though (5/6)

So in essence #COVIDー19 is opening up the debate (again) about deregulation to speed up drug development to save patients but ensuring certain regulations are in place to get good information to keep patients safe

Again, here's the story. Fin. (6/6)

news.bloomberglaw.com/health-law-and…