Category: fda

A Bitter Battle Over the ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks at Risk

Patients who depend upon special drugs to treat rare diseases are caught in the crossfire as drugmakers and the FDA battle over regulations that reward companies for developing treatments for relatively small pools of patients.

A Health-Heavy State of the Union

President Joe Biden’s 2023 State of the Union address leaned heavily on health care issues. Biden took a victory lap for recent accomplishments like capping prescription drug costs for seniors on Medicare. He also urged Congress to make permanent the boosted premium subsidies under the Affordable Care Act, and he sparred with Republicans on threats to cut Social Security and Medicare. Also this week, both sides in the abortion debate are bracing for a court decision out of Texas that could, at least temporarily, make the abortion pill mifepristone illegal nationwide. Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet join KHN chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews Kate Baicker of the University of Chicago about a possible middle ground in the effort to get universal health insurance coverage.

‘We Ain’t Gonna Get It’: Why Bernie Sanders Says His ‘Medicare for All’ Dream Must Wait

As he takes the reins of the Senate Health, Education, Labor & Pensions Committee, the independent from Vermont and implacable champion of “Medicare for All” maps out his strategy for negotiating with Republicans — and Big Pharma.

FDA Experts Are Still Puzzled Over Who Should Get Which Covid Shots and When

A single booster seems to prevent death and hospitalization in most people, but protection from the current vaccines wanes within months. FDA experts say they need to know more from the Centers for Disease Control and Prevention to decide the best long-term strategy.

Part I: The State of the Abortion Debate 50 Years After ‘Roe’

In Part I of this special two-part episode, Alice Miranda Ollstein of Politico, Sandhya Raman of CQ Roll Call, and Sarah Varney of KHN join KHN chief Washington correspondent Julie Rovner to discuss how the abortion debate has evolved since the Supreme Court overturned the nationwide right to abortion in 2022, and what might be the flashpoints for 2023. Also in this episode, Rovner interviews Elizabeth Nash of the Guttmacher Institute, about changing reproductive policies in the states.

GOP House Opens With Abortion Agenda

Leaders of the new Republican-led U.S. House kicked off their legislative agenda with two bills supported by anti-abortion groups. While neither is likely to become law, the move demonstrates how abortion will continue to be an issue in Washington. Meanwhile, as open enrollment for the Affordable Care Act nears its end in most states, the number of Americans covered by the plans hits a new high. Margot Sanger-Katz of The New York Times, Alice Miranda Ollstein of Politico, and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these topics and more. Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too.

States Challenge Biden to Lower Drug Prices by Allowing Imports From Canada

Colorado has joined Florida, New Hampshire, and New Mexico in seeking federal permission to import prescription drugs from Canada. President Joe Biden endorsed the approach in his 2020 campaign but has yet to approve any state plan.

KHN’s ‘What the Health?’: Congress Races the Clock

Sen. Raphael Warnock’s re-election in Georgia will give Democrats a clear-cut Senate majority for the first time in nearly a decade. Meanwhile, the current Congress has only days left to tackle major unfinished business on the health agenda, including fending off scheduled pay cuts for doctors and other health providers in the Medicare program. Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Anna Edney of Bloomberg News, and Sandhya Raman of CQ Roll Call join KHN’s Julie Rovner to discuss these topics and more. Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too.

The Business of Clinical Trials Is Booming. Private Equity Has Taken Notice.

Private equity-backed Headlands Research heralded its covid-19 vaccine trials as a chance to boost participation among diverse populations, then it shuttered multiple sites that conducted them.

As STDs Proliferate, Companies Rush to Market At-Home Test Kits. But Are They Reliable?

The popularity of at-home covid tests has amplified calls from public health researchers and diagnostic companies to make home testing similarly routine for sexually transmitted diseases. But FDA guidelines are lagging.