Latest News On FDA

Latest KFF Health News Stories

How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters

KFF Health News Original

With real-time data streaming in from highly specialized researchers in the U.S. and abroad, NIH scientists became convinced that boosting the covid-19 vaccine was needed to save lives, prompting the president to announce a plan with a Sept. 20 start date. Scientists at the regulatory agencies weren’t yet convinced. A meeting Friday will determine what happens next. Here’s the story from behind the scenes.

KHN’s ‘What the Health?’: Vaccine Approval Moves the Needle on Covid

KFF Health News Original

The FDA’s formal approval of the first vaccine to prevent covid-19 may or may not prompt doubters to go out and get shots, but it has clearly prompted employers to make vaccination a work requirement. Meanwhile, moderates and liberals in the U.S. House put aside their differences long enough to keep a giant social-spending bill on track, at least for now. Joanne Kenen of Politico, Tami Luhby of CNN and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Plus, for “extra credit,” the panelists suggest their favorite health policy stories of the week they think you should read, too.

Apple, Bose and Others Pump Up the Volume on Hearing Aid Options, Filling Void Left by FDA

KFF Health News Original

A 2017 law designed to help lower the cost of hearing aids mandated that federal officials set rules for a new class of devices consumers could buy without needing to see an audiologist. But those regulations are still on hold.

The White House Says Boosters for All. Here’s What You Need to Know.

KFF Health News Original

Federal officials are preparing to offer those who received Pfizer or Moderna covid vaccines a third dose in September. But the FDA and CDC are still reviewing the data for final clearance.

‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors

KFF Health News Original

In another twist on covid vaccine hesitancy, blood centers say they are starting to hear from transfusion patients demanding blood from unvaccinated donors. Experts say the option is neither practical nor medically justifiable.

Mensaje del CEO de Pfizer al público: confíen en nosotros con el refuerzo de la vacuna contra covid

KFF Health News Original

Pfizer anunció su ensayo global de fase 3 sobre una tercera dosis a mediados de julio. La fecha de finalización de ese ensayo es en 2022. Los resultados de la fase 3 suelen ser necesarios antes de la aprobación oficial.

KHN’s ‘What the Health?’: Delta Blues

KFF Health News Original

Covid is back with a vengeance, with some people clamoring for booster shots while others harden their resistance to getting vaccinated at all. Meanwhile, the Food and Drug Administration is pushing hard on drugmaker Pfizer’s request to upgrade the emergency authorization for its vaccine and give it final approval. Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Also, for “extra credit,” the panelists suggest their favorite health policy stories of the week they think you should read, too.

Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign

KFF Health News Original

The makers of Aduhelm, a drug approved last month despite concerns raised by experts about its effectiveness, have launched a website and ads designed to urge people who are worried about their memory to ask doctors about testing. But some health advocates say it is misleading because some memory loss with aging is normal.

Analysis: Necessary or Not, Covid Booster Shots Are Probably on the Horizon

KFF Health News Original

In today’s pharmaceutical universe, a simple “safe and effective” determination by the Food and Drug Administration to approve a drug can be manipulated to sell products of questionable value. And drugmakers can profit handsomely.

KHN’s ‘What the Health?’: Here Comes Reconciliation

KFF Health News Original

Democrats in Congress reached a tentative agreement to press ahead on a partisan bill that would dramatically expand health benefits for people on Medicare, those who buy their own insurance and individuals who have been shut out of coverage in states that didn’t expand Medicaid. Meanwhile, controversy continues to rage over whether vaccinated Americans will need a booster to protect against covid-19 variants, and who will pay for a new drug to treat Alzheimer’s disease. Rachel Cohrs of Stat and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Also, Rovner interviews KHN’s Rae Ellen Bichell, who reported and wrote the latest KHN-NPR “Bill of the Month” episode about a mother and daughter who fought an enormous emergency room bill.

Dying Patients With Rare Diseases Struggle to Get Experimental Therapies

KFF Health News Original

When patients with common terminal illnesses such as cancer seek permission for compassionate use of therapies in the testing stage, their requests often are approved. But those with more unusual illnesses say drug companies are rarely willing to provide access.

Paying Billions for Controversial Alzheimer’s Drug? How About Funding This Instead?

KFF Health News Original

Aduhelm, approved by the Food and Drug Administration last month despite questions about its efficacy, could be prescribed to at least 1 million patients a year, for a price tag of about $56 billion. Experts suggest there might be better ways to spend that money.

KHN’s ‘What the Health?’: Un-Trumping the ACA

KFF Health News Original

The Biden administration is moving to undo many of the changes the Trump administration made to the enrollment process for the Affordable Care Act to encourage more people to sign up for health insurance. Meanwhile, Congress is opening investigations into the controversial approval by the Food and Drug Administration of an expensive drug that might (or might not) slow the progression of Alzheimer’s disease. Joanne Kenen of Politico, Kimberly Leonard of Insider and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Also, Rovner interviews Marshall Allen of ProPublica about his new book, “Never Pay the First Bill: And Other Ways to Fight the Health Care System and Win.”