The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
Category: fda
FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices
In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.
Elite Hospitals Plunge Into Unproven Stem Cell Treatments
Critics are concerned about the explosion in controversial stem cell procedures offered by clinics — and, increasingly, respected hospitals.
Health Officials’ Plug For Next FDA Chief: Go Big On E-Cig Regulation
With Scott Gottlieb making his exit from the Food and Drug Administration’s top spot, city and country health officials call for backup in the fight to curb teen use of e-cigarettes.
FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices
In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.
Device-Safety Experts To FDA: Make Data Public
For almost two decades, device makers have sent reports of incidents to databases hidden from public view.
FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records
In an interview, FDA Commissioner Scott Gottlieb reacts to a KHN/Fortune investigation of the drawbacks and risks of electronic health records.
Podcast: KHN’s ‘What The Health’ Surprise! Fixing Surprise Medical Bills Is Harder Than it Looks
Joanne Kenen of Politico, Anna Edney of Bloomberg News and Alice Miranda Ollstein of Politico join KHN’s Julie Rovner to discuss the efforts to curb “surprise” medical bills to patients who inadvertently get out-of-network care; a look at where the 2020 presidential candidates stand on health; and the Trump administration’s efforts to end HIV in the U.S. Also, Rovner interviews Food and Drug Administration Commissioner Scott Gottlieb, who is leaving his job in early April.
Podcast: KHN’s ‘What The Health?’ The Karma Of Cutting Medicare
Stephanie Armour of The Wall Street Journal, Alice Ollstein of Politico and Rebecca Adams of CQ Roll Call join KHN’s Julie Rovner to discuss the suggested cuts to health programs in President Donald Trump’s budget proposal, the latest on lawsuits challenging work requirements for Medicaid enrollees and the FDA’s crackdown on e-cigarettes. Plus, for extra credit, the panelists recommend their favorite health policy stories of the week.
Podcast: KHN’s ‘What The Health?’ The Karma Of Cutting Medicare
Stephanie Armour of The Wall Street Journal, Alice Ollstein of Politico and Rebecca Adams of CQ Roll Call join KHN’s Julie Rovner to discuss the suggested cuts to health programs in President Donald Trump’s budget proposal, the latest on lawsuits challenging work requirements for Medicaid enrollees and the FDA’s crackdown on e-cigarettes. Plus, for extra credit, the panelists recommend their favorite health policy stories of the week.
