Category: fda

The Crisis Is Officially Ending, but Covid Confusion Lives On

The public health emergency declaration for covid-19 ends May 11, ushering in major changes in how Americans can access and pay for the vaccines, treatments, and tests particular to the culprit coronavirus. But not everyone will experience the same changes, creating a confusing patchwork of coverage — not unlike health coverage for other diseases. Meanwhile, outside advisers to the FDA formally recommended allowing a birth control pill to be sold without a prescription. If the FDA follows the recommendation, it would represent the first over-the-counter form of hormonal contraception. Margot Sanger-Katz of The New York Times, Tami Luhby of CNN, and Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico join KFF Health News’ Julie Rovner to discuss these issues and more. Plus for “extra credit” the panelists suggest health policy stories they read this week they think you should read, too.

Legal Pot Is More Potent Than Ever — And Still Largely Unregulated

As marijuana has become far more mainstream, potent, and sometimes dangerous, uneven regulation at the state and federal levels leaves consumers at risk.

Federal Rules Don’t Require Period Product Ingredients on Packaging Labels. States Are Stepping In.

New York and California have passed laws requiring disclosure of ingredients on menstrual product packaging. Advocates want more transparency across the U.S.

Listen: Mifepristone Remains Available for Now. What Happens Next?

The Supreme Court on April 21 ruled that the abortion pill mifepristone should remain widely available while the lower courts consider the issue, blocking earlier rulings that banned or restricted access to the drug. KFF Health News’ Julie Rovner joined NPR’s “Weekend All Things Considered” to discuss the complicated case.

The Confusing Fate of the Abortion Pill

The legality and availability of the abortion pill mifepristone is in question after a federal judge in Texas canceled the FDA’s approval of the first drug used in the two-drug medication abortion regimen. A 5th Circuit Court of Appeals panel overruled that decision in part, saying the pill should remain available, but only under the onerous restrictions in place before 2016. Meanwhile, another federal judge in Washington state issued a ruling in a separate case that conflicts with the Texas decision, ordering the FDA not to roll back any of its restrictions on the drug. Victoria Knight of Axios, Shefali Luthra of The 19th, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more.

Doctors’ Lesson for Drug Industry: Abortion Wars Are Dangerous to Ignore

The American Medical Association ducked the abortion issue for years and now sees its members’ professional opinions second-guessed by lawmakers and judges. PhRMA is following the same playbook.

Doctors’ Lesson for Drug Industry: Abortion Wars Are Dangerous to Ignore

The American Medical Association ducked the abortion issue for years and now sees its members’ professional opinions second-guessed by lawmakers and judges. PhRMA is following the same playbook.

FDA Evaluates ‘Safety Concerns’ Over Dental Devices Featured in KHN-CBS Investigation

A KHN and CBS News investigation found that a dental appliance called the AGGA has been used by more than 10,000 patients, and multiple lawsuits allege it has caused grievous harm to patients.

A Judicial Body Blow to the ACA

A federal judge in Texas has dealt a big setback to the Affordable Care Act. The same judge who tried in 2018 to declare the entire ACA unconstitutional has now ruled that the law’s main provisions for preventive care are unconstitutional and, therefore, unenforceable nationwide. Also this week, North Carolina became the 40th state to expand Medicaid under the ACA. Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sandhya Raman of CQ Roll Call join KHN chief Washington correspondent Julie Rovner to discuss these issues and more.

Judge Signals He Could Rule to Halt Sales of Common Abortion Pill

A U.S. District Court case is being widely followed because the judge’s decision could overturn the FDA’s approval of mifepristone two decades ago. With abortion rights polling well even in red states, anti-abortion activists are increasingly turning to the courts to achieve their aims.