The FDA Is Broken
How the Food and Drug Administration messes up approval of new drugs including the new one, aducanumab, that supposedly helps Alzheimer’s disease patients. More
Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous
Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts. More
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
Criticisms of the US Food and Drug Administration’s accelerated approval process have resurfaced after the recent approval of aducanumab (Aduhelm) for dementia. Elisabeth Mahase finds that the process is plagued by missing efficacy data and questionable evidence. More
Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway
This Viewpoint discusses the US Food and Drug Administration’s accelerated approval pathway and proposes the need for reforms as well as the timely completion of postapproval trials. More
Is the FDA’s Drug Approval Process Broken?
A Q&A with physician and former FDA advisor Aaron Kesselheim on why he resigned to protest the approval of a new Alzheimer’s drug — and the reforms necessary to prevent it from happening again. More
Trump’s FDA commissioner takes job at Moderna backer
Stephen Hahn joins Flagship Pioneering, which launched Moderna a decade ago and made billions from its coronavirus vaccine. More
Op-ed: FDA’s ‘abundance of caution’ should extend to supplements
Supplements — vitamins, hormones, herbs, enzymes and probiotics — are only lightly regulated, and the existing rules are poorly enforced. The pandemic underlines why this is not a good thing, writes Sarah Green Carmichael in an op-ed. More
Biden’s choice and FDA’s loosening standards of evidence
The US Food and Drug Administration is widely considered the world’s premier regulator of drugs and devices, but critics say three decades of deregulation have resulted in increasingly lax oversight and lower standards of evidence, writes Jeanne Lenzer More
Assessment of Outcomes Associated With the Use of Newly Approved Oncology Drugs in Medicare Beneficiaries
This cohort study evaluates the differences in survival, duration of therapy, and treatment patterns between clinical trial patients and older adults with Medicare receiving cancer drugs for metastatic solid cancers in usual practice. More
Approval and Coverage of Cancer Drugs in England, Canada, and the US
Most drug approvals are based on surrogate markers, such as tumor shrinkage in a fraction of patients (response rate) or delayed tumor growth (progression-free survival). These surrogates use arbitrary percentage cutoffs and are not optimized to ensure that a drug can improve the length or quality of life. More
What Americans Don’t Know About Their Medications
People who have faced debilitating side effects say we need better warnings on drugs. The FDA hasn’t been enthusiastic. More
Federal officials misappropriated millions earmarked for biomedical research: Investigation
Using those funds for non-BARDA purposes was "so common, there was even a name for it within the agency: "Bank of BARDA," OSC said. More
Azar’s ‘Sunset Rule’ will bring a dangerous new dawn for health regulation
The Sunset Rule would force HHS to accomplish a herculean task: reassess the impacts of its 17,000-plus regulations every 10 years. More
The Federal Health Authority, a Federal Reserve System for Health Care: COVID-19 Has Exposed a Need for Change
The current COVID-19 pandemic shares many of the same causes as the Panic of 1907: lack of a coordinated federal response, lax state-level regulations, and absence of clear strategies to respond and recover from the initial outbreak. Therefore, we propose a new entity paralleling the Federal Reserve —the Federal Health Authority (FHA)—to anticipate health shocks, coordinate future responses, and address longer-term problems in the nation’s health and health care. More
For two decades, the FDA approval process for opioids had numerous shortcomings, study finds
“Our study shows that there are evidence gaps that the FDA needs to address in approving new opioids,” said study co-author Thomas Moore. More
Increase transparency at the FDA: We need sunlight to fight the pandemic
To restore public trust in the FDA's response to the Covid-19 pandemic, it needs to recommit to transparency and promote accountability. More
The Disasters That Built the FDA and Where We Go From Here
A series of disasters shaped the FDA into what it is today. We need to make sure that this pandemic moves the agency in the right direction. More
Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency
Vaccine development and use depend on data-driven assessment of benefits and risks, first by regulatory bodies, and then more subjectively, millions of times over, by individual physicians and patients. More
Trump administration limits FDA review of some coronavirus tests
The policy change has been a major point of tension for weeks between HHS and FDA. More
The FDA Needs to Get Back to Basics
The agency should take every measure to ensure the safety and efficacy of prescription drugs under emergency use authorization. More