Holly Fernandez Lynch
@hollylynchez.bsky.social
Academic lawyer/bioethicist studying pharmaceutical policy, access to investigational medicines, IRB quality (www.aereo.org), and clinical research ethics and regulation, with a splash of psychedelics.
Deadline extended to 11/10! Consider nominating yourself or a colleague to join ASLME's board. It's an exciting time for the org and we're looking for "ideas people," those w/ strong governance experience, and committed leaders at the intersection of law, med, and ethics.
aslme.org/nominate-som...
aslme.org/nominate-som...
November 4, 2025 at 12:13 PM
Deadline extended to 11/10! Consider nominating yourself or a colleague to join ASLME's board. It's an exciting time for the org and we're looking for "ideas people," those w/ strong governance experience, and committed leaders at the intersection of law, med, and ethics.
aslme.org/nominate-som...
aslme.org/nominate-som...
Looking forward to discussing these issues tomorrow: petrieflom.law.harvard.edu/events/detai...
November 4, 2025 at 12:06 PM
Looking forward to discussing these issues tomorrow: petrieflom.law.harvard.edu/events/detai...
We've been here before but let's see how FDA responds this time w/ Prasad wielding his influence. (I'm sure WSJ ed board + Loomer are already drafting their 2 cents...)
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
November 4, 2025 at 1:26 AM
We've been here before but let's see how FDA responds this time w/ Prasad wielding his influence. (I'm sure WSJ ed board + Loomer are already drafting their 2 cents...)
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
Good point. I think I read more than may have been intended in this passage:
November 2, 2025 at 8:32 PM
Good point. I think I read more than may have been intended in this passage:
And a great conclusion by @shaylalove.bsky.social
November 1, 2025 at 11:02 AM
And a great conclusion by @shaylalove.bsky.social
Such a bad take. Right, FDA won't look at your application if you don't follow a set of legal requirements established to protect study participants, prove a drug is safe and effective, and confirm it can be manufactured appropriately.
November 1, 2025 at 11:00 AM
Such a bad take. Right, FDA won't look at your application if you don't follow a set of legal requirements established to protect study participants, prove a drug is safe and effective, and confirm it can be manufactured appropriately.
Here's how @reshmagar.bsky.social and I put the same sentiment in the LA Times this weekend: www.latimes.com/opinion/stor....
But that's one difficulty with this FDA, a disconnect between what they say and what they seem willing to do.
But that's one difficulty with this FDA, a disconnect between what they say and what they seem willing to do.
October 22, 2025 at 1:06 PM
Here's how @reshmagar.bsky.social and I put the same sentiment in the LA Times this weekend: www.latimes.com/opinion/stor....
But that's one difficulty with this FDA, a disconnect between what they say and what they seem willing to do.
But that's one difficulty with this FDA, a disconnect between what they say and what they seem willing to do.
This is a screen grab from yesterday's FDA Direct podcast with Makary + Prasad. The rest of the podcast was off the wall, but this part gets it exactly right. I just want to understand how they square this with what Makary did for leucovorin.
www.fda.gov/news-events/...
www.fda.gov/news-events/...
October 22, 2025 at 1:02 PM
This is a screen grab from yesterday's FDA Direct podcast with Makary + Prasad. The rest of the podcast was off the wall, but this part gets it exactly right. I just want to understand how they square this with what Makary did for leucovorin.
www.fda.gov/news-events/...
www.fda.gov/news-events/...
Looking forward to joining this panel discussion on November 5.
petrieflom.law.harvard.edu/events/detai...
petrieflom.law.harvard.edu/events/detai...
October 20, 2025 at 10:44 PM
Looking forward to joining this panel discussion on November 5.
petrieflom.law.harvard.edu/events/detai...
petrieflom.law.harvard.edu/events/detai...
Our article, "Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty," is out now in @jlme-journal.bsky.social.
The thesis is simple: when psychedelics are being pursued for medical use, they should be regulated like other medicines.
www.cambridge.org/core/journal...
The thesis is simple: when psychedelics are being pursued for medical use, they should be regulated like other medicines.
www.cambridge.org/core/journal...
October 17, 2025 at 10:09 AM
Our article, "Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty," is out now in @jlme-journal.bsky.social.
The thesis is simple: when psychedelics are being pursued for medical use, they should be regulated like other medicines.
www.cambridge.org/core/journal...
The thesis is simple: when psychedelics are being pursued for medical use, they should be regulated like other medicines.
www.cambridge.org/core/journal...
New from @pzettler.bsky.social @reshmagar.bsky.social + me in @jhppl.bsky.social.
We describe themes driving historic FDA reforms, explain how what's happening under Trump2 is different + call for principles to guide FDA reform and activity across administrations.
read.dukeupress.edu/jhppl/articl...
We describe themes driving historic FDA reforms, explain how what's happening under Trump2 is different + call for principles to guide FDA reform and activity across administrations.
read.dukeupress.edu/jhppl/articl...
October 8, 2025 at 3:16 PM
New from @pzettler.bsky.social @reshmagar.bsky.social + me in @jhppl.bsky.social.
We describe themes driving historic FDA reforms, explain how what's happening under Trump2 is different + call for principles to guide FDA reform and activity across administrations.
read.dukeupress.edu/jhppl/articl...
We describe themes driving historic FDA reforms, explain how what's happening under Trump2 is different + call for principles to guide FDA reform and activity across administrations.
read.dukeupress.edu/jhppl/articl...
We describe 4 alternatives that could work in tandem:
1. Approval by committee
2. Mandatory public comment when a director wants to deviate from a committee's recommendation
3. Mandatory adcoms when that happens
4. Adjustments to FDA's scientific dispute resolution procedures 2/
1. Approval by committee
2. Mandatory public comment when a director wants to deviate from a committee's recommendation
3. Mandatory adcoms when that happens
4. Adjustments to FDA's scientific dispute resolution procedures 2/
September 30, 2025 at 11:36 PM
We describe 4 alternatives that could work in tandem:
1. Approval by committee
2. Mandatory public comment when a director wants to deviate from a committee's recommendation
3. Mandatory adcoms when that happens
4. Adjustments to FDA's scientific dispute resolution procedures 2/
1. Approval by committee
2. Mandatory public comment when a director wants to deviate from a committee's recommendation
3. Mandatory adcoms when that happens
4. Adjustments to FDA's scientific dispute resolution procedures 2/
Everything is still on fire but rescuing a new puppy helps a lot. (As does our older rescue pup but it turns out 2 are better than 1.)
September 26, 2025 at 7:41 PM
Everything is still on fire but rescuing a new puppy helps a lot. (As does our older rescue pup but it turns out 2 are better than 1.)
"Research is compromised when it is informed by bias or is designed to reach a predetermined conclusion. Compromised research should not be considered when approving and regulating medications, including mifepristone."
September 25, 2025 at 9:45 PM
"Research is compromised when it is informed by bias or is designed to reach a predetermined conclusion. Compromised research should not be considered when approving and regulating medications, including mifepristone."
September 25, 2025 at 9:44 PM
No, FDA did this all on its own, relying on the reg below. They said they will ask GSK to submit a "prior approval supplemental NDA" to revise the prescribing info to include "the essential scientific information needed for the safe and effective use of these drug products" for CFD.
September 23, 2025 at 11:29 AM
No, FDA did this all on its own, relying on the reg below. They said they will ask GSK to submit a "prior approval supplemental NDA" to revise the prescribing info to include "the essential scientific information needed for the safe and effective use of these drug products" for CFD.
Join the NASEM Health and Medicine Division on 7/15 for the virtual public release webinar of our new report examining challenges and solutions to better aligning investment in therapeutic development with disease burden and unmet need. Register here: bit.ly/3ICet41
July 11, 2025 at 5:21 PM
Join the NASEM Health and Medicine Division on 7/15 for the virtual public release webinar of our new report examining challenges and solutions to better aligning investment in therapeutic development with disease burden and unmet need. Register here: bit.ly/3ICet41
Our special issue, “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” is now live in @jlme-journal.bsky.social. Check out the full line up of leading voices on spotting, addressing, and preventing misconduct.
www.cambridge.org/core/journal...
www.cambridge.org/core/journal...
June 17, 2025 at 7:54 PM
Our special issue, “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” is now live in @jlme-journal.bsky.social. Check out the full line up of leading voices on spotting, addressing, and preventing misconduct.
www.cambridge.org/core/journal...
www.cambridge.org/core/journal...
Same thing for non biologic drugs. The statute provides grounds for refusing an application based on various factors related to safety and effectiveness - not government priorities. If those factors don't apply, the Secretary "shall" approve. www.law.cornell.edu/uscode/text/...
April 11, 2025 at 3:04 PM
Same thing for non biologic drugs. The statute provides grounds for refusing an application based on various factors related to safety and effectiveness - not government priorities. If those factors don't apply, the Secretary "shall" approve. www.law.cornell.edu/uscode/text/...
The statute says "The Secretary shall approve" biological products that are "safe, pure, and potent." There's no room for disapproval based on the government having different "priorities." Industry should be screaming at the top of their lungs over this. www.law.cornell.edu/uscode/text/...
April 11, 2025 at 3:01 PM
The statute says "The Secretary shall approve" biological products that are "safe, pure, and potent." There's no room for disapproval based on the government having different "priorities." Industry should be screaming at the top of their lungs over this. www.law.cornell.edu/uscode/text/...
Thank you to @statnews.com for including me in your 2025 STATUS List featuring "50 influential people shaping the future of health and life sciences"!
Some influencers for better, some for worse. Always working to be on the right side of that divide.
Some influencers for better, some for worse. Always working to be on the right side of that divide.
April 10, 2025 at 2:10 PM
Thank you to @statnews.com for including me in your 2025 STATUS List featuring "50 influential people shaping the future of health and life sciences"!
Some influencers for better, some for worse. Always working to be on the right side of that divide.
Some influencers for better, some for worse. Always working to be on the right side of that divide.
A joint statement from www.AEREO.org, @weareprimr.bsky.social, @aahrpp.bsky.social, careq.ucsd.edu, calling on the administration to protect + restore OHRP against loss of expert leadership and
provide it with the resources needed to ensure public safety + a trustworthy human research enterprise.
provide it with the resources needed to ensure public safety + a trustworthy human research enterprise.
April 4, 2025 at 1:23 PM
A joint statement from www.AEREO.org, @weareprimr.bsky.social, @aahrpp.bsky.social, careq.ucsd.edu, calling on the administration to protect + restore OHRP against loss of expert leadership and
provide it with the resources needed to ensure public safety + a trustworthy human research enterprise.
provide it with the resources needed to ensure public safety + a trustworthy human research enterprise.
Time to re-read "Science: The Endless Frontier"
nsf-gov-resources.nsf.gov/2023-04/Endl...
nsf-gov-resources.nsf.gov/2023-04/Endl...
March 24, 2025 at 11:14 AM
Time to re-read "Science: The Endless Frontier"
nsf-gov-resources.nsf.gov/2023-04/Endl...
nsf-gov-resources.nsf.gov/2023-04/Endl...
Thanks to Amy Ben-Arieh (not on Bsky, I think) for noting this change. The Common Rule version posted on the OHRP website has changed "gender" to "sex" in the section describing IRB membership requirements (without flagging the change or noting a revision date). The eCFR version remains unchanged.
February 5, 2025 at 12:23 PM
Thanks to Amy Ben-Arieh (not on Bsky, I think) for noting this change. The Common Rule version posted on the OHRP website has changed "gender" to "sex" in the section describing IRB membership requirements (without flagging the change or noting a revision date). The eCFR version remains unchanged.