nicotine products
Does Toucan Sam vape?
Follow your nose. It always knows. The FDA authorized fruit-flavored vapes for the first time on Tuesday.
You might think that would spark outcry from public health experts. Instead, the decision divides researchers and anti-smoking advocates, Sarah Todd and Lizzy Lawrence report.
Equally controversial is how the FDA’s decision came about. Read more about the layers of political meddling in what is supposed to be a scientifically based process.
fda
More FDA political interference
Lizzy has another story about disagreement between career scientists and political appointees.
This one is about Sanofi asking FDA to pull its type 1 diabetes drug, teplizumab, out of Makary’s new speedy drug review program.
Drug center Director Tracy Beth Høeg disagreed with a staff decision to approve the drug, according to sources familiar with the dispute who requested anonymity due to fear of reprisal. The agency has missed its goal date of April 21 to deliver a decision to Sanofi.
Agency sources have previously warned STAT that drugs under the voucher program are particularly vulnerable to political interference.
Read more.
drug pricing
$529 billion
That’s how much the Trump administration projects that its most favored nation drug pricing policy could save the federal government over a decade.
But don’t assume that STAT’s Daniel Payne accepted that very large savings estimate without scrutiny. For starters, the estimate assumes the deals will run indefinitely, even though a couple of companies have said they run for three years.
The report raises many questions, but it also offers the most detailed explanation so far of the secret deals that President Trump’s team cut with brand drugmakers. Read more.
anti-depressant drugs
HHS tackles ‘overmedication’
Health secretary Robert F. Kennedy Jr. has long been critical of what he sees as overprescribing of anti-depressants. Speaking at the MAHA Institute this week, he announced that his department would take action to curb the “dependency crisis.”
Among the actions HHS is planning: Introducing Centers for Medicare and Medicaid billing guidance that would incentivize providers to taper their patients off of a specific class of anti-depressants, known as selective serotonin reuptake inhibitors, or SSRIs, releasing a “Dear Colleague” letter to doctors directing them to “strengthen informed consent” in prescribing medication, and releasing a forthcoming report by the the Substance Abuse and Mental Health Services Administration on prescribing trends.
SAMHSA is also planning educational webinars on side effects of psychiatric medications and deprescribing this summer while the Health Resources and Services Administration will host webinars on “holistic care” for community health centers. HHS is also planning to convene an expert panel this July to discuss tapering off of medications.
Kennedy has (against existing evidence) long linked SSRI use to violence, including mass shootings, and has argued that trying to come off of an SSRI is worse than quitting heroin.
According to CDC data, just over 13% of adults have reported using an anti-depressant. Last year, HHS released a report finding that, from 2006 to 2023, U.S. children and teens using SSRIs increased from 1.5% to 3.6%, which the report’s authors said remains low, but reflects changing mental health needs. — Chelsea Cirruzzo
