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*
At @aspenideas.bsky.social Health where the CMS Deputy Administrator and Chief of Staff is claiming that CBO estimates that the reconciliation bill will cause millions will lose coverage are wrong. She does not have an estimate of her own. 🤯🤯🤯 #aspenhealth #MedSky
June 24, 2025 at 4:41 PM
At @aspenideas.bsky.social Health where the CMS Deputy Administrator and Chief of Staff is claiming that CBO estimates that the reconciliation bill will cause millions will lose coverage are wrong. She does not have an estimate of her own. 🤯🤯🤯 #aspenhealth #MedSky
Thank you @by-cjewett.bsky.social @nytimes.com for chatting with me about this piece and my concerns that the priorities outlined by our national regulator read like PhRMA's own FDA playbook 👇 in calling for speedier reviews & less evidentiary rigor. www.nytimes.com/2025/06/10/h... #MedSky
June 10, 2025 at 4:39 PM
Thank you @by-cjewett.bsky.social @nytimes.com for chatting with me about this piece and my concerns that the priorities outlined by our national regulator read like PhRMA's own FDA playbook 👇 in calling for speedier reviews & less evidentiary rigor. www.nytimes.com/2025/06/10/h... #MedSky
Truly honored to receive the Bernard Lown Award for Social Responsibility from the @lowninstitute.org. Dr. Lown's persistence & ability to mobilize the public against injustice are lessons I will carry forward as we continue to fight for a health system centered around our patients. Thank you 🙏🏿
June 6, 2025 at 5:57 PM
Truly honored to receive the Bernard Lown Award for Social Responsibility from the @lowninstitute.org. Dr. Lown's persistence & ability to mobilize the public against injustice are lessons I will carry forward as we continue to fight for a health system centered around our patients. Thank you 🙏🏿
FDA is supposed to be an independent regulator. Last week, the FDA Commissioner wrote in @nejm.org that he recommends COVID-19 vaccines for pregnant people. Now, he stands besides the HHS Secretary as he announces that the COVID-19 vaccine will not be recommended for healthy pregnant people. #MedSky
May 27, 2025 at 4:43 PM
FDA is supposed to be an independent regulator. Last week, the FDA Commissioner wrote in @nejm.org that he recommends COVID-19 vaccines for pregnant people. Now, he stands besides the HHS Secretary as he announces that the COVID-19 vaccine will not be recommended for healthy pregnant people. #MedSky
❌ guidance document on measuring sex differences in medical product trials
❌ a page on how FDA conducts cross-cutting regulatory science research to address health disparities & achieve health equity
❓ a flag on the REMS page giving 2 weeks notice of modification/removal
❌ a page on how FDA conducts cross-cutting regulatory science research to address health disparities & achieve health equity
❓ a flag on the REMS page giving 2 weeks notice of modification/removal
May 22, 2025 at 5:21 PM
❌ guidance document on measuring sex differences in medical product trials
❌ a page on how FDA conducts cross-cutting regulatory science research to address health disparities & achieve health equity
❓ a flag on the REMS page giving 2 weeks notice of modification/removal
❌ a page on how FDA conducts cross-cutting regulatory science research to address health disparities & achieve health equity
❓ a flag on the REMS page giving 2 weeks notice of modification/removal
❌ Spanish-language information for patients on increasing representation in clinical trials
❌ various patient health resources on clinical trials from the Office of Minority Health and Health Equity
❌ general info on the Risk Evaluation and Mitigation Strategies (REMS) program
❌ various patient health resources on clinical trials from the Office of Minority Health and Health Equity
❌ general info on the Risk Evaluation and Mitigation Strategies (REMS) program
May 22, 2025 at 5:21 PM
❌ Spanish-language information for patients on increasing representation in clinical trials
❌ various patient health resources on clinical trials from the Office of Minority Health and Health Equity
❌ general info on the Risk Evaluation and Mitigation Strategies (REMS) program
❌ various patient health resources on clinical trials from the Office of Minority Health and Health Equity
❌ general info on the Risk Evaluation and Mitigation Strategies (REMS) program
The government had informed @drsforamerica.bsky.social & @publiccitizen.bsky.social that they had completed their individual review of sites temporarily restored & only found 4 to require notice before taking them down. This reasoning is flawed & ignored the harms incurred for patients & doctors.
May 22, 2025 at 4:05 PM
The government had informed @drsforamerica.bsky.social & @publiccitizen.bsky.social that they had completed their individual review of sites temporarily restored & only found 4 to require notice before taking them down. This reasoning is flawed & ignored the harms incurred for patients & doctors.
BREAKING: HHS & health agencies including @fda.gov have again purged websites including guidance required under law around ensuring that clinical trials include participants that represent real-world patients. Government health agencies will be taking down more - let us know if you see this. #MedSky
May 22, 2025 at 3:39 PM
BREAKING: HHS & health agencies including @fda.gov have again purged websites including guidance required under law around ensuring that clinical trials include participants that represent real-world patients. Government health agencies will be taking down more - let us know if you see this. #MedSky
This is terrific to see building off of @drsforamerica.bsky.social lawsuit filed by @publiccitizen.bsky.social similarly challenging the removal of public health data & clinical guidance from federal health agency websites plus also noting that under the RIF, future data collection will be stymied.
May 21, 2025 at 1:42 AM
This is terrific to see building off of @drsforamerica.bsky.social lawsuit filed by @publiccitizen.bsky.social similarly challenging the removal of public health data & clinical guidance from federal health agency websites plus also noting that under the RIF, future data collection will be stymied.
@drsforamerica.bsky.social is in the @nytimes.com among other inspiring researchers, clinicians, orgs, & states working to save health and science as the administration continues to gut biomedical research and healthcare access domestically and abroad. #MedSky #EpiSky www.nytimes.com/2025/05/19/o...
May 19, 2025 at 3:02 PM
@drsforamerica.bsky.social is in the @nytimes.com among other inspiring researchers, clinicians, orgs, & states working to save health and science as the administration continues to gut biomedical research and healthcare access domestically and abroad. #MedSky #EpiSky www.nytimes.com/2025/05/19/o...
Does anyone else find this weird? FDA officials are "taking off their FDA hat" to make statements about FDA regulation & policy. Here's the Commissioner at FDLI & the Principal Deputy Commissioner at the #MAHA Institute launch. Regardless of what you say, you ARE, in fact, the regulator. #MedSky
May 16, 2025 at 6:00 PM
As @agencyiq.bsky.social points out, the reduction-in-force at @fda.gov has led to the various centers regulating drugs, biologics, and other medical products to stop communicating to the public including patients and clinicians about its regulatory activities including new drug approvals. #MedSky
May 15, 2025 at 2:26 PM
As @agencyiq.bsky.social points out, the reduction-in-force at @fda.gov has led to the various centers regulating drugs, biologics, and other medical products to stop communicating to the public including patients and clinicians about its regulatory activities including new drug approvals. #MedSky
Anyone know what this part of the "most-favored nation" drug pricing EO means for @fda.gov given the language "maybe be unsafe, ineffective, or improperly marketed"? At worst, FDA could withdraw drugs that are thought to be, but not necessarily proven to be ineffective or unsafe? #MedSky #EpiSky
May 12, 2025 at 9:15 PM
@fda.gov Commissioner's answer here to @jeremyfaust.bsky.social is not quite true. As we @yalecrrit.bsky.social have shown, drugs are increasingly approved using expedited development & review pathways, which have cut down development & approval times significantly. jamanetwork.com/journals/jam...
April 30, 2025 at 1:53 PM
@fda.gov Commissioner's answer here to @jeremyfaust.bsky.social is not quite true. As we @yalecrrit.bsky.social have shown, drugs are increasingly approved using expedited development & review pathways, which have cut down development & approval times significantly. jamanetwork.com/journals/jam...
Very much hope this is true. I wrote last week in @theconversation.com how important FOIA offices are for ensuring public accountability of federal agencies & catalyzing change that has been instrumental in protecting patients: theconversation.com/the-sudden-d... h/t @owermohle.bsky.social #MedSky
April 22, 2025 at 10:02 PM
Very much hope this is true. I wrote last week in @theconversation.com how important FOIA offices are for ensuring public accountability of federal agencies & catalyzing change that has been instrumental in protecting patients: theconversation.com/the-sudden-d... h/t @owermohle.bsky.social #MedSky
The closure of @fda.gov FOIA offices across FDA has also impacted my own work as we often file such requests to get access to efficacy and safety information that FDA considered when making approval decisions. In checking on some recent requests, here's the response I received.
April 16, 2025 at 4:37 PM
The closure of @fda.gov FOIA offices across FDA has also impacted my own work as we often file such requests to get access to efficacy and safety information that FDA considered when making approval decisions. In checking on some recent requests, here's the response I received.
🤷🏿♀️ Trump tariffs on medicines coming: seems unlikely that manufacturing of essential drugs will shift to the US overnight & firing of FDA inspectors will lead to delays in ensuring these production facilities can be used. Our patients will feel this when they lose access to their medicines. #MedSky
April 9, 2025 at 2:55 PM
🤷🏿♀️ Trump tariffs on medicines coming: seems unlikely that manufacturing of essential drugs will shift to the US overnight & firing of FDA inspectors will lead to delays in ensuring these production facilities can be used. Our patients will feel this when they lose access to their medicines. #MedSky
While Pharma may have escaped Trump tariffs for now in exchange for promises of domestic manufacturing, DOGE/HHS gutting FDA capacity will make it difficult to ensure these new production lines are inspected & approved to ensure patient safety. Remember what happened with baby formula? #MedSky
April 4, 2025 at 4:44 PM
While Pharma may have escaped Trump tariffs for now in exchange for promises of domestic manufacturing, DOGE/HHS gutting FDA capacity will make it difficult to ensure these new production lines are inspected & approved to ensure patient safety. Remember what happened with baby formula? #MedSky
As we said in @medpagetoday.bsky.social, if FDA doesn't spend Congressionally appropriated funds to a certain level, then it can't use industry user fees that ensure timely review of drugs, devices, etc. Mass firing at FDA may lead to this & slow down treatment approvals. From @agencyiq.bsky.social:
April 3, 2025 at 8:56 PM
As we said in @medpagetoday.bsky.social, if FDA doesn't spend Congressionally appropriated funds to a certain level, then it can't use industry user fees that ensure timely review of drugs, devices, etc. Mass firing at FDA may lead to this & slow down treatment approvals. From @agencyiq.bsky.social:
Senators Cassidy & @sanders.senate.gov have asked the HHS Secretary to testify before the HELP Committee on April 10 on the mass layoffs he authorized across federal public health agencies that have purged scientific expertise needed to keep patients safe. #MedSky #EpiSky @drsforamerica.bsky.social
April 1, 2025 at 7:57 PM
Senators Cassidy & @sanders.senate.gov have asked the HHS Secretary to testify before the HELP Committee on April 10 on the mass layoffs he authorized across federal public health agencies that have purged scientific expertise needed to keep patients safe. #MedSky #EpiSky @drsforamerica.bsky.social
More FDA departures of experienced senior officials regulating drugs, devices, & tobacco. Not to mention how callous and cruel it is to have public servants find out their service has ended when trying to use a badge to get into the building. #MedSky #EpiSky www.statnews.com/2025/04/01/h...
April 1, 2025 at 12:53 PM
More FDA departures of experienced senior officials regulating drugs, devices, & tobacco. Not to mention how callous and cruel it is to have public servants find out their service has ended when trying to use a badge to get into the building. #MedSky #EpiSky www.statnews.com/2025/04/01/h...
Adding insult to injury- FDA loses its case against the American Clinical Laboratory Association & Association for Molecular Pathology challenging the Lab-Developed Test Rule regulating common tests that w/o premarket review have led to patient harm. Huge implications for FDA's regulatory authority.
March 31, 2025 at 8:41 PM
Adding insult to injury- FDA loses its case against the American Clinical Laboratory Association & Association for Molecular Pathology challenging the Lab-Developed Test Rule regulating common tests that w/o premarket review have led to patient harm. Huge implications for FDA's regulatory authority.
Dr. Redfield's comments as a former CDC official is extremely disappointing & demonstrates a lack of understanding of how the FDA works - career officials serve in FDA roles for reviewing new medical products to ensure integrity & independence of the process. These are not political roles. #MedSky
March 31, 2025 at 6:28 PM
Dr. Redfield's comments as a former CDC official is extremely disappointing & demonstrates a lack of understanding of how the FDA works - career officials serve in FDA roles for reviewing new medical products to ensure integrity & independence of the process. These are not political roles. #MedSky
@fda.gov's top vaccine & biologics official resigns. Meanwhile, the HHS Secretary appoints an unlicensed physician with a checkered research history to study debunked links between vaccines and autism, and spreads misinformation that is actively harming kids. www.nytimes.com/2025/03/28/h... #MedSky
March 29, 2025 at 2:48 AM
@fda.gov's top vaccine & biologics official resigns. Meanwhile, the HHS Secretary appoints an unlicensed physician with a checkered research history to study debunked links between vaccines and autism, and spreads misinformation that is actively harming kids. www.nytimes.com/2025/03/28/h... #MedSky
From @wsj.com, RFK Jr./DOGE are planning to cut 10,000 technical & scientific experts from HHS on top of the 10,000 who have left amid the Trump administration's efforts to silence experts, shroud these agencies in further secrecy, & promote disinformation. 3500 or 19% of FDA will be fired. #MedSky
March 27, 2025 at 1:19 PM