Category: fda

Pfizer CEO to Public: Just Trust Us on the Covid Booster

As pharmaceutical companies declare a need for boosters, scientists and doctors emphasize there’s no proof yet.

KHN’s ‘What the Health?’: Delta Blues

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.

Diabetes Drug’s New Weight Loss Formula Fuels Cost-Benefit Debate

Health plans’ coverage of the medication, branded as Wegovy — which has a $1,300-a-month price tag — is not a sure thing.

Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales

Pharmaceutical companies routinely cover the cost of patient copays for expensive drugs under private insurance. A federal judge could make the practice legal for millions on Medicare as well.

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

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

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

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

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.

Why We May Never Know Whether the $56,000-a-Year Alzheimer’s Drug Actually Works

It could take years for follow-up studies to prove Aduhelm slows the disease — or doesn’t. Meanwhile, its maker will profit.

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

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.