Policy Engagement
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2024
- Health Care Is About to Get Even More Litigious- Bloomberg (7/12/24)
- ‘It’s astronomical’: AbbVie led the way in paying doctors to pitch its drugs last year- MM+M (7/12/24)
- Environmentalists, Public Health Advocates Worry about Ability to Regulate Industry after Supreme Court’s Decision Overturning Chevron- KQED (7/11/24)
- AbbVie dramatically outspent its pharma company rivals in 2023 to promote its drugs to doctors- STAT News (7/05/2024)
- Chevron doctrine ruling a “gut-punch’ for US health and environment-experts- The Guardian (7/06/24)
- How the Supreme Court has roiled U.S. health-care agencies- The Washington Post (7/02/24)
- How controversial was the decision by FDA’s Peter Marks to approve Sarepta’s gene therapy? Check its footnotes- STAT News (7/02/24)
- Supreme Court Imperils an Array of Federal Rules- The New York Times (6/28/24)
- The Justices just shackled Biden and every future president-and created new messes for Congress to solve- Politico (6/28/24)
- The Most Important Supreme Court Case You’ve Probably Never Heard Of- PJ Media (6/25/24)
- Surrogate Markers Used for Many New Drug Approvals Lack Follow-Up Outcomes Data: Study- Medscape (5/17/24)
- Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review ...- JAMA Network Open (5/01/24)
- Prices of Expensive Diabetes Medicines and Weight-loss Drugs Are Drastically Higher Than Production Costs- Yale School of Medicine (4/29/24)
- Diabetes Medication Can Be Manufactured at Lower Cost, New Study Says-Yale School of Medicine (4/24/24)
- Graft much? Doctors received $12 billion from drug, device makers between 2013-2022- Science Blog (3/28/24)
- $5 Ozempic? New study sparks calls for Novo Nordisk to cut prices- Becker’s Hospital Review (3/28/24)
- Heckmann and Wong Receive R01 award from National Institute of Mental Health for ...- Yale School of Medicine (3/26/24)
- Sustainable Price Estimates for Diabetes Medicines Revealed - Mirage News (3/28/24)
- Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications- American Diabetes Association (3/27/24)
- Georgia patients struggle to find drugs they need due to shortages- The Atlanta Journal-Constitution (3/06/24)
- 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
- Counting on Inulin Manufacturers To Do the Right Thing is Not a Good Policy Prescription to Avert Shortages- Health Affairs (7/12/2024)
- The Future of FDA Advisory Committees: Protecting Public Health and Preserving Public Trust-Health Affairs (7/01/24)
- Estimating The Effects OF COVID-19 On Globalized Markets For Active Pharmaceutical Ingredients-Health Affairs (7/2024)
- To receive testimony on the Department o... | U.S. Senate Committee on Armed Services- United States Senate Committee on Armed Services (4/12/24)
- Victory Over Big Pharma Will Take More Than the IRA | MedPage Today (4/04/24)
- Implications for Public Health Regulation if Chevron Deference Is Overturned- JAMA (3/20/24)
- 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
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Comments on National Institutes of Health (NIH) Office of Science Policy: Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning (7/22/24)
- Amicus Brief for The Center For Investigative Reporting And Will Evans v Dept of Labor (7/17/24)
- Comment on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 (submitted on 7/02/24)
- Comment FDA-2016-D-3561: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (4/29/2024)
- Comment on FDA-2023-D-4395: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Guidance for Industry (2/20/2024)
- Comments 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 (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