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Biologic drugs, made from living organisms, and the cheaper biosimilar drugs that mimic them are more complex than chemical drugs and their generic counterparts. The Food and Drug Administration says biosimilars are as safe and effective as the biologics, and doctors agree ā but they are cautious about changing the treatment regimen of patients doing well.
The Food and Drug Administration has been mired in controversies related to drug approvals and covid vaccines, all without a permanent leader.
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 werenāt yet convinced. A meeting Friday will determine what happens next. Hereās the story from behind the scenes.
KHN and California Healthline staff made the rounds on national and local media this week to discuss their stories. Hereās a collection of their appearances.
The FDAās 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 KHNās Julie Rovner to discuss these issues and more. Plus, for āextra credit,ā the panelists suggest their favorite health policy stories of the week they think you should read, too.
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.
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.
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.
As pharmaceutical companies declare a need for boosters, scientists and doctors emphasize thereās no proof yet.
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 Pfizerās 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 KHNās Julie Rovner to discuss these issues and more. Also, for āextra credit,ā the panelists suggest their favorite health policy stories of the week they think you should read, too.
Health plansā coverage of the medication, branded as Wegovy ā which has a $1,300-a-month price tag ā is not a sure thing.
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.
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.
In todayās pharmaceutical universe, a simple āsafe and effectiveā 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.
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 didnāt 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 Alzheimerās disease. Rachel Cohrs of Stat and Sarah Karlin-Smith of the Pink Sheet join KHNās Julie Rovner to discuss these issues and more. Also, Rovner interviews KHNās Rae Ellen Bichell, who reported and wrote the latest KHN-NPR āBill of the Monthā episode about a mother and daughter who fought an enormous emergency room bill.
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.
It could take years for follow-up studies to prove Aduhelm slows the disease ā or doesnāt. Meanwhile, its maker will profit.
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.
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 Alzheimerās disease. Joanne Kenen of Politico, Kimberly Leonard of Insider and Sarah Karlin-Smith of the Pink Sheet join KHNās Julie Rovner to discuss these issues and more. Also, Rovner interviews Marshall Allen of ProPublica about his new book, āNever Pay the First Bill: And Other Ways to Fight the Health Care System and Win.ā
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 ā or could actually do harm.
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