Five Things We Found In The FDA鈥檚 Hidden Device Database
The Food and Drug Administration released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices. Here鈥檚 what we鈥檝e learned so far.
FDA
361-380 of 477 results
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FDA Overlooked Red Flags In Drugmaker鈥檚 Testing of New Depression Medicine
In March, a chemical cousin of the anesthetic and club drug ketamine was approved for the treatment of patients with intractable depression. But critics say studies presented to the FDA provided at best modest evidence it worked and did not include information about the safety of the drug, Spravato, for long-term use.
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Must-Reads Of The Week From Brianna Labuskes
Newsletter editor Brianna Labuskes wades through hundreds of health care policy stories each week, so you don't have to.
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More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren鈥檛 reported through its traditional public reporting system.
By Sydney Lupkin and Christina Jewett -
Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device
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.
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Price Check On Drug Ads: Would Revealing Costs Help Patients Control Spending?
As part of his plan to tamp down drug pricing, President Donald Trump wants pharmaceutical companies to provide cost information in drug ads 鈥 just like side effects.
By Julie Appleby and Sydney Lupkin -
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.
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Elite Hospitals Plunge Into Unproven Stem Cell Treatments
Critics are concerned about the explosion in controversial stem cell procedures offered by clinics 鈥 and, increasingly, respected hospitals.
By Liz Szabo -
Health Officials鈥 Plug For Next FDA Chief: Go Big On E-Cig Regulation
With Scott Gottlieb making his exit from the Food and Drug Administration鈥檚 top spot, city and country health officials call for backup in the fight to curb teen use of e-cigarettes.
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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.
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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.
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Analysis: Why Americans Shouldn鈥檛 Feel Grateful For $137 Insulin
Only by the bizarre logic of the U.S. pharmaceutical industry does this drug count as any kind of generic.
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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.
By Fred Schulte and Erika Fry, Fortune -
Podcast: KHN鈥檚 鈥榃hat The Health?鈥 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鈥檚 Julie Rovner to discuss the efforts to curb 鈥渟urprise鈥 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鈥檚 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.
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Must-Reads Of The Week From Brianna Labuskes
Newsletter editor Brianna Labuskes wades through hundreds of health articles from the week so you don鈥檛 have to.
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Podcast: KHN鈥檚 鈥榃hat The Health?鈥 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鈥檚 Julie Rovner to discuss the suggested cuts to health programs in President Donald Trump鈥檚 budget proposal, the latest on lawsuits challenging work requirements for Medicaid enrollees and the FDA鈥檚 crackdown on e-cigarettes. Plus, for extra credit, the panelists recommend their favorite health policy stories of the week.
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FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers
The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.
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Must-Reads Of The Week From Brianna Labuskes
Newsletter editor Brianna Labuskes wades through hundreds of health articles from the week so you don鈥檛 have to.
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Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, leaving doctors and medical sleuths in the dark.
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Cities And Counties Unlikely To Heed FDA Warning On Importing Foreign Drugs
The Food and Drug Administration claims CanaRX, a company used by more than 500 cities, counties and school districts to help their employees get cheaper drugs from overseas, has sent 鈥渦napproved鈥 and 鈥渕isbranded鈥 drugs to U.S. consumers, jeopardizing their safety.