Category: fda

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.

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

The Biden administration is moving to undo many of the changes the Trump administration made to the enrollment process for the Affordable Care Act, in an effort 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 new 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.”

In a Murky Sea of Mental Health Apps, Consumers Left Adrift

Venture capitalists have poured billions into the digital mental health space, sensing an area of unmet demand that is ripe for disruption. The problem for consumers is separating the apps that might help from those that offer little more than distraction — or could actually do harm.

KHN’s ‘What the Health?’: The ACA Lives

In a surprisingly strong 7-2 decision, the Supreme Court turned back the latest constitutional challenge to the Affordable Care Act, likely heralding the end of GOP efforts to strike the law in its entirety through court action. Meanwhile, Democratic lawmakers are looking for ways to expand health benefits. Joanne Kenen of Politico, Mary Ellen McIntire of CQ Roll Call and Rachel Cohrs of Stat join KHN’s Julie Rovner to discuss these issues and more. Also, Rovner interviews Andy Slavitt, who recently stepped down from the Biden administration’s covid response team, about his new book on the pandemic.