2. With some help from @pzettler I've annotated the bill, to provide shortcuts to important cross references, comparisons to prior versions, and important improvements and remaining concerns about federal #righttotry:https://drive.google.com/file/d/1pmtOGi_5xMYRcGR-jIqEkqn3atv3rGx3/view?usp=sharing …
-
-
Show this thread
-
3. My overall impression is that this version is quite similar to the Senate bill:https://www.congress.gov/bill/115th-congress/senate-bill/204/text …
Show this thread -
4. It most problematically still cuts
@US_FDA out, despite the fact that they aren't the roadblock and in a substantial number of cases, help protect patient safety even when approving#expandedaccess requests.Show this thread -
5. It requires patient
#consent under the terms of existing FDA regs, which actually prohibit statements about releasing parties for liability from#negligence - which the new bill would do.Show this thread -
6. It preserves a role for
#IRBs in approving#righttotry requests. This won't substitute for@US_FDA oversight, but at least it's something. And perhaps#IRBs will seek FDA guidance prior to approval, which seems permissible.Show this thread -
7. It would require companies to provide more stats about their
#righttotry requests, provisions, and outcomes, which is a good thing.Show this thread -
8. But - and this is most important - it is still nothing more than a
#righttoask, selling patients false hope that could hurt them. Phase 1 studies do not demonstrate safety. Period. They demonstrate being safe *enough* for further testing. There's a difference.Show this thread -
9. My criticisms of the Senate bill, with
@SteveJoffe in@NEJM, continue to apply: http://www.nejm.org/doi/full/10.1056/NEJMp1714054 …. And so do our fears about broader implications for@US_FDA's mission.Show this thread -
10. Take it away,
@pzettler,@ABatemanHouse,@SteveJoffe,@AmeetSarpatwari,@gregggonsalves, and others!Show this thread - End of conversation
New conversation -
Loading seems to be taking a while.
Twitter may be over capacity or experiencing a momentary hiccup. Try again or visit Twitter Status for more information.