2024

Research Articles

Ten-Year Medicare Use and Spending on the 10 Drugs Selected for Negotiation Under the Inflation Reduction Act (Journal of the American Heart Association,1/23/25)
Online Advertising of Compounded Glucagon-Like Peptide-1 Receptor Agonists (JAMA Health Forum, 1/17/25)
Assessing Medicare’s Coverage With Evidence Development Program (Health Affairs,1/06/25)
Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications (Health Affairs,12/03/24)
Representativeness of Studies Required Under Medicare's Coverage With Evidence Development Program (JAMA,11/13/24)
Industry Payments to Physicians by Competing Manufacturers Within Novel Therapeutic Classes (JAMA,11/07/24)
Adoption of the voluntary conflict of interest statement on PubMed (PLOS ONE, 10/30/24)
Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence (BMJ Open,10/26/24)
National Trends in and Concentration of Industry Payments to U.S. Psychiatrists, 2015-2021 (Psychiatric Services,10/23/24)
Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021 (JAMA Network Open, 10/01/24)
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 (Annals of Internal Medicine, 9/17/24)
Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study (BMC Medical Research Methodology, 8/28/24)
Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies (JAMA Network Open, 8/27/24)
Estimating The Effects Of COVID-19 On Globalized Markets For Active Pharmaceutical Ingredients (Health Affairs, 7/01/24)
Consent Form Reporting on ClinicalTrials.Gov, 2013-2023 (JAMA Network Open, 6/21/24)
Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals (Published in JAMA Network Open on 5/01/24;
Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022 (Medical Devices: Evidence and Research, 4/29/24)
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments (JAMA, 4/22/24)
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study (BMJ Medicine, 4/05/24)
Industry Payments to US Physicians by Specialty and Product Type (JAMA 3/28/24)
Estimated Sustainable Cost-based Prices for Diabetes Medicines (JAMA Network Open, 3/27/24)
Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016–2019 data (Journal of Pharmaceutical Policy and Practice, 2/29/24)

Commentaries in Medical Journals

Integrating Equity Into Licensing Agreements For Taxpayer-Funded Technologies (Health Affairs Forefront, 12/19/24)
Technology transfer, intellectual property, and the fight for the soul of WHO (PLOS Global Public Health, 12/05/24)
Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters (Annals of Internal Medicine on 11/19/24)
Enhancing Medical Device Postmarketing Safety Surveillance—The Case of Inferior Vena Cava Filters (JAMA,11/06/24)
Understanding Drug Supply Shortages in the US and Canada (JAMA, 10/31/24)
Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process (Annals of Internal Medicine, 10/08/24)
At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? (JAMA Internal Medicine, 8/12/24
Counting On Insulin Manufacturers To Do The Right Thing Is Not A Good Policy Prescription To Avert Shortages (Health Affairs Forefront, 7/12/24)
The Future Of FDA Advisory Committees: Protecting Public Health And Preserving Public Trust (Health Affairs Forefront, 7/01/24)
Lessons from Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications (American Diabetes Association on 3/27/24)
Implications for Public Health Regulation if Chevron Deference Is Overturned (JAMA, 3/20/24)
If Left Unchecked: Lessons Learned from Unfettered U.S. Government Support of the NIH-Moderna Vaccine (Cambridge University Press, 3/04/24)
US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion (BMJ, 2/21/24)
Reforming The Medical Device Recall Process—A Call For Accountability (Health Affairs Forefront, 2/15/24)
Overruling Chevron and FDA Decision-Making (Yale Journal on Regulation, 2/09/24)

Opinion Pieces in Lay Media

The Fight to Reclaim Technical Expertise Amid the Fall of Chevron Deference (AI Now, 8/01/24)
To get a fair deal on Wegovy, buying Novo Nordisk might not be Medicare's worst option (STAT News, 7/23/24)
Victory Over Big Pharma Will Take More Than the IRA (MedPage Today, 4/04/24)

White Paper

Transforming Clinical Trials Results Reporting in the United States (4/22/24)

Public Comments

US v Gilead Science, Inc et al (12/19/24)
American Clinical Laboratories Association et al v FDA and Association of Molecular Pathology et al v FDA (11/04/24)
Comment on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Studies (9/27/24)
Comments on Food and Drug Administration (FDA) Draft Guidance on “Considerations in Demonstrating Interchangeability With a Reference Product: Update (8/20/24)
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 (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 (4/29/24)
Comment on FDA-2023-D-4395: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Guidance for Industry (2/20/24)
Comment 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)

In the Media