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 — 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 weren’t yet convinced. A meeting Friday will determine what happens next. Here’s the story from behind the scenes.
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.
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.
With political pressure mounting to recommend boosters, what are the experts saying about how current vaccines work and the potential benefits of another dose?
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 there’s 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 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.
Health plans’ coverage of the medication, branded as Wegovy — which has a $1,300-a-month price tag — is not a sure thing.
