2023

Research Articles

Geographic and Demographic Representation in Industry-sponsored, US-based Clinical Trials of Systemic Lupus Erythematosus Therapies (Journal of Rheumatology 12/15/2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics (JAMA 12/11/2023)
Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics (JAMA Internal Medicine 11/03/2023
Evaluating Regulatory Pathways and Clinical Development Times for Novel Therapeutics (JAMA Network Open, 8/31/23)
Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership (JAMA Internal Medicine, 8/21/23)
Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices (JAMA, 8/17/23)
Transparency of Results Reporting in Cancer Clinical Trials (JAMA Network Open, 8/09/23)
Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models (Scientific Data, 8/08/23)
Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov (Journal of Neurology, Neurosurgery & Psychiatry, 7/13/23)
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study (BMJ, 7/05/23)
US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019 (JAMA Network Open, 6/26/23)
US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics (BMJ Evidence-Based Medicine, 5/22/23)

Commentaries in Medical Journals

Data Sharing—A New Era for Research Funded by the U.S. Government (New England Journal of Medicine 12/28/2023)
Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program (JAMA Cardiology 10/25/2023_
Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative (BMJ Surgery, Interventions, & Health Technologies, 9/28/23
The Accelerated Approval Program for Cancer Drugs — Finding the Right Balance (The New England Journal of Medicine, 9/14/23)
Extending the US Food and Drug Administration’s Postmarket Authorities (JAMA Health Forum, 6/09/23)
U.S Orphan Drug Act (BMJ, 5/09/23)
Challenges and solutions to advancing health equity with medical devices (Nature Biotechnology, 4/10/23)
Ensuring Public Trust in an Empowered FDA | NEJM (New England Journal of Medicine, 4/03/23)
Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross-sectional study (BMJ Medicine, 1/05/23)
Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study (BMJ Open, 1/23/23)
US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021 (JAMA Internal Medicine, 2/13/2023)

Opinion Pieces in Lay Media

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment (Harvard Law, 9/28/23)
Do Advocacy Groups always put patients first? (Medpage Today, 8/29/23)
Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy? (MedPage Today, 5/18/23)
Want to make drugs, including insulin, affordable? End patent abuse. | GUEST COMMENTARY (The Baltimore Sun, 3/03/23)

Public Comments

Amicus Brief for Relentless v Dept of Commerce (Supreme Court case that may overturn federal agency deference).(12/22/2023)

Comment on FDA-2023-D-2318: Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (12/18/23)

Comment on FDA-2023-D-3133: Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (12/05/23)

Comment on FDA-2023-D-3132: Evidentiary Expectations for 510(k) Implant Devices (12/05/23)

Public Comment on [CMS-3421-NC] Medicare Program; Transitional Coverage for Emerging Technologies (9/13/23)

Addressing Drug Shortages: Emergent Challenges, Structural Factors, and Potential Policy Reforms (9/11/23)

Public Comment on 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, Guidance for Industry [FDA-2023-D-0559] (9/11/23)

Public Comment on Increasing Patient Access to At-Home Use Medical Technologies [FDA-2023-N-1956] (8/29/23)

Public Comment on Centers for Medicare and Medicaid Services Coverage with Evidence Development Proposed Guidance Document (8/21/23)

Response to RFI on Drug Shortages (7/07/23)

Public Comment on the Food and Drug Administration Draft Guidance “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics” [FDA-2023-D-0110]. (5/24/23)

Public Comment on the Food and Drug Administration Draft Guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” [FDA-2022-D-2870] (5/22/23)

In the Media

Rx Shortages Prompt Search by Congress for a Lasting Solution, Specialty Pharmacy Continuum (12/01/23)
Huge Spending — But Little Sharing of Research Results — on Cancer Drugs, UCLA Anderson Review (11/15/23)
Americans Don’t Get to Have the Best New COVID Drug, The Atlantic (10/25/23)
Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone, Yale School of Medicine News (10/05/2023)
Health Subcommittee members at odds over drafted drug shortage legislation, Fierce Healthcare (9/15/23)
House Democrats push back on Republicans’ drug shortage proposals during legislative hearing, Endpoints News (9/14/23)
No 'Silver Bullet' for Generic Drug Shortage, House Members Told, Medpage Today (9/14/23)
Yale Experts Discuss Impact of Medicare Price-negotiation Legislation, Yale Daily News (9/11/23)
Yale Researchers Develop Nasal Spray mRNA Vaccine for COVID-19 Yale Daily News (9/08/23)
(STUDY) 50% of paid staff at top patient advocacy groups have direct ties to Pharma industry, Sharyl Attkisson(8/27/23)
Top Patient Advocacy Orgs Have Industry Ties in Leadership, Study Shows, Medpage Today (8/21/23)
Vaccine Politics May be to Blame for GOP Excess Deaths, Washington Post (7/24/23)
Newly approved Alzheimer's drug may not work as well on women, Axios (7/11/23)
Novo Nordisk bought prescribers over 450,000 meals and snacks to promote drugs like Ozempic, STAT News (7/05/23)
Is a gift ever just a gift, Substack.com (6/30/23)
FDA’s Peter Marks overrode agency staff to approve Sarepta’s Duchenne gene therapy, Endpoints News (6/23/23)
When Dying Patients Want Unproven Drugs, The New Yorker (6/19/23)
The strain COVID vaccines might target next, Axios (6/15/23)
How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful, Pink Sheet (6/12/23)
FDA removes neurologist with financial ties to Eisai and Biogen from Alzheimer’s advisory panel, STAT News (6/05/23)
Alzheimer’s Groups Seek Broad Medicare Coverage for Pricey Drugs, Bloomberg Law (6/01/23)
Promising new Alzheimer's drugs present patients with tough choices, Axios (5/15/23)
Gene therapy for muscular dystrophy stirs hopes and controversy, NPR & Houston Public Media (5/02/23)
Will New FDA Rules Help Dial Back Expedited Drugs?, Undark Magazine(4/12/23)
Real-World Evidence For Accelerated Approval: NASEM Is A Tough Crowd, Pink Sheet (3/13/23)
Clinical trials on new cancer drugs still fall far short of including key data on several demographic groups, Medical Xpress (2/23/23)
Gold standard? 10% of newly approved drugs were based on studies that didn't achieve goals, USA Today (2/13/23)
Lack of diversity in clinical trials is leaving women and patients of color behind and harming the future of medicine, The Conversation Podcast (2/09/23)
Health experts want FDA safety review of fast-tracked Alzheimer's drug, Axios (2/06/23)
Loophole enables FDA approval of unsafe medical devices, Yale study finds, Yale News (1/19/23)
Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax, Pink Sheet (1/16/23)
Adding device identifiers to claims forms—a key step to advance medical device safety, BMJ (1/11/23)
New Alzheimer's drug may have limited real-world impact, Axios (1/10/2023)
Approval of a second controversial Alzheimer's drug is dividing medical experts, The Washington Post (1/09/23)