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HollyLynchez's profile
Holly Fernandez Lynch (she/her)
Holly Fernandez Lynch (she/her)
Holly Fernandez Lynch (she/her)
@HollyLynchez

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Holly Fernandez Lynch (she/her)

@HollyLynchez

Bioethics+law faculty @PennMEHP @PennCarey_Law @GreenwallFDN scholar, @HastingsCenter fellow IRB quality (http://aereo.org ), pre-approval access (CUPA), FDA policy

Philadelphia, PA
…dicalethicshealthpolicy.med.upenn.edu/faculty-all/ho…
Joined April 2017

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    1. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      1. The House is poised to pass its #righttotry bill this week. Here's the version released late Friday night: http://docs.house.gov/billsthisweek/20180312/HR____.pdf …

      4 replies 16 retweets 14 likes
      Show this thread
    2. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      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 …

      1 reply 5 retweets 5 likes
      Show this thread
    3. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      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 …

      1 reply 2 retweets 1 like
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    4. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      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.

      1 reply 3 retweets 5 likes
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    5. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      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.

      1 reply 2 retweets 3 likes
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    6. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      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.

      2 replies 1 retweet 3 likes
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      Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

      7. It would require companies to provide more stats about their #righttotry requests, provisions, and outcomes, which is a good thing.

      10:18 AM - 11 Mar 2018
      • 1 Retweet
      • 3 Likes
      • Carrie Swope Michael D. Becker Dr. Alison Bateman-House
      1 reply 1 retweet 3 likes
        1. New conversation
        2. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

          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.

          1 reply 4 retweets 8 likes
          Show this thread
        3. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

          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.

          1 reply 1 retweet 3 likes
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        4. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

          10. Take it away, @pzettler, @ABatemanHouse, @SteveJoffe, @AmeetSarpatwari, @gregggonsalves, and others!

          1 reply 0 retweets 3 likes
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        5. Holly Fernandez Lynch (she/her)‏ @HollyLynchez 11 Mar 2018

          11. Oh, and this:http://thehill.com/opinion/healthcare/377794-heres-how-to-structure-successful-right-to-try-laws …

          1 reply 0 retweets 2 likes
          Show this thread
        6. End of conversation

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