politics
HHS radical transparency? Democrats beg to differ
Health secretary Robert F. Kennedy Jr. said he was “happy to” release, by last Friday, the contract of a longtime vaccine critic hired by the Department of Health and Human Services.
He didn’t, according to Daniel Payne.
Democrats want more information on vaccine critic David Geier, who was hired to review vaccine data. Geier has been given unusual access to confidential data at Kennedy’s behest and was selected to lead a government study on autism.
It’s common for health secretaries to face criticism from the opposing party for not responding to their questions. But Democrats are using Kennedy’s assertions of radical transparency against him, listing a whole lot of outstanding requests.
Read more.
addiction
Trump’s confusing policies on illicit drugs
On April 18, the Trump administration promoted psychedelics as treatments for mental health conditions, and on April 23 Trump’s acting attorney general signed an order reclassifying medical marijuana to a lower tier of scheduled substances. The following day, the FDA gave priority review vouchers to three psychedelic-based mental health treatments.
As Lev Facher put it, the days of ‘Just say no,’ seemed long gone.
But on April 24, the administration announced its opposition to harm reduction services for people who use illicit drugs, Lev reports. In dual letters from the Substance Abuse and Mental Health Services Administration, the administration returned to what before Biden was standard drug policy fare: promoting abstinence-first interventions, opposing harm reduction strategies, and viewing law enforcement as a primary tool in reducing drug-related harms.
Read more.
medical devices
RAPID communication with Medicare
Federal regulators announced a new Medicare coverage pathway for breakthrough devices, Mario Aguilar and Katie Palmer report.
The new Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, will try to synchronize the FDA’s premarket review process and Medicare’s independent process of determining whether to cover devices once on the market.
The program aims to address long-standing industry complaints that it takes too long for Medicare to pay for innovative technology.
Read more about the many open questions about how the program will work in practice.
vaccines
New hep B vaccination policy will be expensive and deadly, researchers project
Last year, a panel of vaccine advisers stacked with vaccine skeptics voted to replace a decades-old recommendation that all babies be vaccinated at birth against hepatitis B.
The new policy, which recommends giving the birth dose only to babies perceived to be at risk of neonatal infection, will lead to increased numbers of infected infants and more cases of chronic hepatitis B infection in children that will generate millions of extra dollars in health care costs, according to two studies, Helen Branswell reports.
Read more.