Reshma Ramachandran
@reshmagar.bsky.social
Assistant Professor, primary care physician, and health services researcher at Yale School of Medicine, Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT); *views expressed here are my own*
Reposted by Reshma Ramachandran
First announced in June, these vouchers are meant to shorten drug review to 2 mos or less. Despite current FDA leadership claiming prior inappropriate industry influence, CRRIT Co-Director @reshmagar.bsky.social noted “cut to now, and it seems like the hen has let the fox into the henhouse.”
December 22, 2025 at 3:44 PM
First announced in June, these vouchers are meant to shorten drug review to 2 mos or less. Despite current FDA leadership claiming prior inappropriate industry influence, CRRIT Co-Director @reshmagar.bsky.social noted “cut to now, and it seems like the hen has let the fox into the henhouse.”
Reposted by Reshma Ramachandran
As we state in our @nejm.org Perspective piece, if FDA is serious about patient safety, then adequate staffing, resources, & true transparency are critical in addition to prioritizing enhancing active safety surveillance, not just increased reporting of safety signals yet to be investigated. #MedSky
December 8, 2025 at 9:02 PM
As we state in our @nejm.org Perspective piece, if FDA is serious about patient safety, then adequate staffing, resources, & true transparency are critical in addition to prioritizing enhancing active safety surveillance, not just increased reporting of safety signals yet to be investigated. #MedSky
for Duchenne muscular dystrophy based on data from FAERS and other sources, including a new black box warning, drug label changes, & withdrawal of an indication approval. However, the agency offered no real explanation of the evidence used in their press release announcement.
a woman is asking how did you get there
ALT: a woman is asking how did you get there
media.tenor.com
December 8, 2025 at 9:02 PM
for Duchenne muscular dystrophy based on data from FAERS and other sources, including a new black box warning, drug label changes, & withdrawal of an indication approval. However, the agency offered no real explanation of the evidence used in their press release announcement.
When reports submitted to FAERS are investigated and used by FDA to take regulatory actions, the agency continues to be opaque about how this data and other sources led to safety actions. FDA recently took significant safety actions for #Elevidys... www.fda.gov/news-events/...
FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent sa...
www.fda.gov
December 8, 2025 at 9:02 PM
When reports submitted to FAERS are investigated and used by FDA to take regulatory actions, the agency continues to be opaque about how this data and other sources led to safety actions. FDA recently took significant safety actions for #Elevidys... www.fda.gov/news-events/...
Previous FDA leadership have laid out these issues with VAERS nicely in their recent NEJM Perspective article: www.nejm.org/doi/full/10....
December 8, 2025 at 9:02 PM
Previous FDA leadership have laid out these issues with VAERS nicely in their recent NEJM Perspective article: www.nejm.org/doi/full/10....
Reposted by Reshma Ramachandran
What does this mean?
-In making a single pivotal clinical trial the default for drug approval, FDA is moving away from the administration’s stated “gold science standard” that calls for a quality minimum of “replicability” and “reproducibility.” (www.whitehouse.gov/presidential...)
-In making a single pivotal clinical trial the default for drug approval, FDA is moving away from the administration’s stated “gold science standard” that calls for a quality minimum of “replicability” and “reproducibility.” (www.whitehouse.gov/presidential...)
Restoring Gold Standard Science
By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 7301 of title 5, United
www.whitehouse.gov
December 4, 2025 at 4:29 PM
What does this mean?
-In making a single pivotal clinical trial the default for drug approval, FDA is moving away from the administration’s stated “gold science standard” that calls for a quality minimum of “replicability” and “reproducibility.” (www.whitehouse.gov/presidential...)
-In making a single pivotal clinical trial the default for drug approval, FDA is moving away from the administration’s stated “gold science standard” that calls for a quality minimum of “replicability” and “reproducibility.” (www.whitehouse.gov/presidential...)
These backroom deals between the administration and Big Pharma will not meaningfully lower drug prices for my patients, especially without health insurance or when their limited, fixed incomes are having to pay more to keep their insurance or for food for them and their families.
November 7, 2025 at 3:12 AM
These backroom deals between the administration and Big Pharma will not meaningfully lower drug prices for my patients, especially without health insurance or when their limited, fixed incomes are having to pay more to keep their insurance or for food for them and their families.
for pharma to opt into to provide drugs at "most-favored nation" prices to Medicaid patients when we're on the precipice of over 10 million losing this coverage. I said it last week before @sanders.senate.gov and Senate HELP and I'll say it again...
November 7, 2025 at 3:12 AM
for pharma to opt into to provide drugs at "most-favored nation" prices to Medicaid patients when we're on the precipice of over 10 million losing this coverage. I said it last week before @sanders.senate.gov and Senate HELP and I'll say it again...
be kicked off their insurance or those who just can't pay for their health insurance anymore because of premium price hikes, having GLP-1s and a handful of other expensive drugs listed on TrumpRx for a price they still cannot pay just doesn't matter. Nor does a voluntary model...
November 7, 2025 at 3:12 AM
be kicked off their insurance or those who just can't pay for their health insurance anymore because of premium price hikes, having GLP-1s and a handful of other expensive drugs listed on TrumpRx for a price they still cannot pay just doesn't matter. Nor does a voluntary model...
We just cannot keep looking at our patients' health policy by policy - all of these are connected and the most vulnerable - the elderly, the poor, those living paycheck to check - are the ones who are and will be harmed the most. For my patients on Medicaid who are about to...
November 7, 2025 at 3:12 AM
We just cannot keep looking at our patients' health policy by policy - all of these are connected and the most vulnerable - the elderly, the poor, those living paycheck to check - are the ones who are and will be harmed the most. For my patients on Medicaid who are about to...
those who told me they're trying to figure out whether or not they could still afford their insurance after they got notices about the premium increases. Not to mention the many others who have expressed fear before about their Medicaid coverage being cut in the near future...
November 7, 2025 at 3:12 AM
those who told me they're trying to figure out whether or not they could still afford their insurance after they got notices about the premium increases. Not to mention the many others who have expressed fear before about their Medicaid coverage being cut in the near future...