Policy Engagement
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2024
- Overruling Chevron and FDA Decision Making, by Nikhil Chaudhry, Dr. Reshma Ramachandran, and Dr. Joseph Ross (Published on 02/09/2024)
- Reshma Ramachandran: Will the Supreme Court Upend Healthcare Regulation? – Yale Insights: Health & Veritas with Howard P. Forman and Harlan M. Krumholz (Published on 01/18/2024)
- The F.D.A. Warned an Asthma Drug Could Induce Despair. Many Were Never Told. – The New York Times (Published on 01/09/24)
2023
- Data Sharing—A New Era for Research Funded by the U.S. Government (Published in the New England Journal of Medicine 12/28/2023)
- Geographic and Demographic Representation in Industry-sponsored, US-based Clinical Trials of Systemic Lupus Erythematosus Therapies (Published in the Journal of Rheumatology 12/15/2023)
- Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics (Published in JAMA 12/11/2023)
- Rx Shortages Prompt Search by Congress for a Lasting Solution - Specialty Pharmacy Continuum (Published on 12/01/23)
- Huge Spending — But Little Sharing of Research Results — on Cancer Drugs - UCLA Anderson Review (Published on 11/15/23)
- Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics (Publish in JAMA Internal Medicine 11/03/2023)
- Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program (Published in JAMA Cardiology 10/25/2023)
- Americans Don’t Get to Have the Best New COVID Drug - The Atlantic (Published on 10/25/23)
- Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone. -Yale School of Medicine News (Published on 10/05/2023)
- Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative (Published in BMJ Surgery, Interventions, & Health Technologies on 9/28/23)
- Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment (Published in Harvard Law on 9/28/23)
- The Accelerated Approval Program for Cancer Drugs — Finding the Right Balance (Published in The New England Journal of Medicine on 9/14/23
- Top Patient Advocacy Orgs Have Industry Ties in Leadership, Study Shows (Published in MedPage Today on 8/21/23)
- Alzheimer's drug Leqembi may not work as well on women (Published in Axios on 7/11/23)
- Ozempic's maker bought prescribers over 450,000 meals last year (statnews.com) (Published in Stat News on 7/05/23)
- Is a gift ever just a gift? (Published in GoozNews on 6/30/23)
- FDA’s Peter Marks overrode agency staff to approve Sarepta’s Duchenne gene therapy (Published on 6/23/23)
- When Dying Patients Want Unproven Drugs (Published in The New Yorker on 6/19/23)
- The strain COVID vaccines might target next (Published in AXIOS on 6/15/23)
- How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful? (Published in Pink Sheet on 6/12/23)
- FDA removes neurologist with financial ties to Eisai and Biogen from Alzheimer’s advisory panel (Published in Stat News on 6/05/23)
- Promising new Alzheimer's drugs present patients with tough choices (Published in AXIOS on 5/15/23)
- Gene therapy for muscular dystrophy stirs hopes and controversy (Published in NPR & Houston Public Media on 5/02/23)
- Will New FDA Rules Help Dial Back Expedited Drugs? (Published in Undark Magazine on 4/12/23)
- Real-World Evidence For Accelerated Approval: NASEM Is A Tough Crowd (Published in Pink Sheet on 3/13/23)
- Clinical trials on new cancer drugs still fall far short of including key data on several demographic groups (Published in Medical Xpress on 2/23/23)
- Gold standard? 10% of newly approved drugs were based on studies that didn't achieve goals (Published in USA Today on 2/13/23)
- Lack of diversity in clinical trials is leaving women and patients of color behind and harming the future of medicine – Podcast (Published in The Conversation on 2/9/23)
- Health experts want FDA safety review of fast-tracked Alzheimer's drug (Published in AXIOS on 2/6/23)
- Loophole enables FDA approval of unsafe medical devices, Yale study finds (Published in Yale News on 1/19/23)
- Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax (Published in Pink Sheet on 1/16/23)
- New Alzheimer's drug may have limited real-world impact (Published in AXIOS on 1/10/2023)
- Approval of a second controversial Alzheimer's drug is dividing medical experts (Published in The Washington Post on 1/9/23)
2022
- Speedier drug approvals hit slowdown as FDA faces scrutiny (Published in AP News on 12/7/22)
- Covaxin Was Rushed Under Political Pressure, Need for Speed: STAT Report (Published in The Wire on 11/16/22)
- GSK’s Blenrep for Multiple Myeloma Misses Mark in Phase III Confirmatory Trial (Published in Biospace on 11/7/22)
- Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period (Published in Pink Sheet on 11/1/22)
- FDA explains why it won’t pull Jazz’s accelerated approval despite a failed confirmatory trial (Published in Endpoints News on 10/26/22)
- Time for Changes at the FDA, Expert Group Says (Published in MedPage Today on 10/21/22)
- Better Antibiotic Trials Sought as Congress Weighs Funding Bill (Published in Bloomberg Law on 10/19/22)
2021
- Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements (published in JAMA on 11/12/21) – Reshma Ramachandran, Christopher J. Morten, Joseph S. Ross
- Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway: The Need for Reforms (published in JAMA Internal Medicine on 7/13/21) - Bishal Gyawali, Joseph S. Ross, Aaron S. Kesselheim
- Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown (published in New England Journal of Medicine on 3/25/21) - Vinay K. Rathi, James L. Johnston, Joseph S. Ross, and Sanket S. Dhruva
- Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment (Published in Harvard Law on 9/28/23)
- A first for Medicaid unwinding (Published in Politico on 8/23/23)
- Alzheimer’s Groups Seek Broad Medicare Coverage for Pricey Drugs (Published in Bloomberg Law on 6/01/23)
- Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy? (Published in MedPage Today on 5/18/23)
- Adding device identifiers to claims forms—a key step to advance medical device safety (Published in the BMJ on 1/11/23)
- Why the PASTEUR Act is no cure for antimicrobial resistance (Published in The Hill on 12/13/22)
- Congress Should Take This Chance to Fix Clinical Trial Diversity (Published in Bloomberg Law on 12/22/22)
- Spontaneous reporting of post-market safety signals: what evidence should support regulatory action? (Published in the BMJ on 10/05/22)
2024
- Comment on FDA-2023-D-4395: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Guidance for Industry (submitted on 2/20/2024)-Julia Etkin, Sanket S. Dhruva, Kushal T. Kadakia, Reshma Ramachandran, Joseph S. Ross, Rita F. Redberg, Sarah Bitter
- Comments of Nikhil Chaudhry, BA, Melissa Barber, PhD, Anthony So, MD, MPA, Ravi Gupta, MD, MS, Joseph S. Ross, MD, MHS, and Reshma Ramachandran, MD, MPP, MHS on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, National Institute of Standards and Technologies (NIST), United States Department of Commerce. 88 FR 85593, Docket No.: 230831-0207 (submitted on 2/06/24)
2023
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Comment on FDA-2023-D-2318: Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (submitted on 12/18/23)- Julia Etkin, Joseph Ross, Holly Fernandez-Lynch, Maryam Mooghali, Reshma Ramachandran
- Comment on FDA-2023-D-3134: Best Practices for Selecting a Predicate Device to Support a Premarket 510(k) Submission (submitted on 12/5/23)- Kushal Kadakia, Vinay Rathi, Sanket Dhruva, Nikhil Chaudhry, Reshma Ramachandran, Joseph Ross, Harlan Krumholz
- Comment on FDA-2023-D-3133: Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (submitted on 12/5/23)- Kushal Kadakia, Vinay Rathi, Sanket Dhruva, Nikhil Chaudhry, Reshma Ramachandran, Joseph Ross, Harlan Krumholz
- Comment on FDA-2023-D-3132: Evidentiary Expectations for 510(k) Implant Devices (submitted on 12/5/23)-Kushal Kadakia, Vinay Rathi, Sanket Dhruva, Nikhil Chaudhry, Reshma Ramachandran, Joseph Ross, Harlan Krumholz
- Amicus Brief for Relentless v Dept of Commerce (Supreme Court case that may overturn federal agency deference)” (Submitted 12/2023) - Reshma Ramachandran, Joseph Ross
- Comment on Draft Guidance, (FDA-2023-D-0559) “Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.” (Submitted on 9/11/23) – Reshma Ramachandran, Joseph Ross, Joshua Wallach
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Comment on “CMS Coverage with Evidence Development Proposed Guidance Document” (submitted on 8/21/23)— Maryam Mooghali, Osman Moneer, Nikhil Chaudhry, Reshma Ramachandran
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Comment on Draft Guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.” (submitted on 7/10/23) – Sanket S. Dhruva, Molly M. Jeffery, Joseph S. Ross
- Comment on Pandemic and All-Hazards Preparedness Act (PAHPA) Discussion Draft to the Senate Health, Education, Labor, and Pensions Committee (submitted on 7/10/23) – Reshma Ramachandran, Nikhil Chaudhry
- Response to Request for Information from Senator Mike Crapo and Chairwoman Cathy McMorris-Rodgers on Drug Shortages (submitted on 7/7/23) – Nikhil Chaudhry, Melissa Barber, Inmaculada Hernandez, Stacie B. Dusetzina, Joseph S. Ross, Reshma Ramachandran
2022
- Comment on Draft Guidance (FDA–2021–D–0789): Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (submitted on 6/10/21) – Jennifer E. Miller, Joseph S. Ross, Reshma Ramachandran, Cary Gross
- Comment on CMS Interim Rule for Prescription Drug and Health Care Spending - CMS-9905-IFC (submitted on 1/25/22) - Kamil F. Faridi, Reshma Ramachandran, Sanket S. Dhruva, Nihar R. Desai, Khera, Khurram Nasir, Harlan M. Krumholz, Joseph S. Ross
- Comment on CMS’s Proposed Decision Issued in Response to the National Coverage Analysis “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” (submitted 2/8/22)
2021
- Comment on Draft Guidance (FDA-2020-D-2307), “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products” – Sanket S. Dhruva, Reshma Ramachandran, Joseph S. Ross