on the hill
Lawmakers push to extend telehealth prescribing
Two Democratic lawmakers are working to preserve health providers' right to prescribe controlled substances via telehealth, including stimulants for ADHD and buprenorphine for opioid addiction.
A new bill being drafted by Sen. Mark Warner (D-Va.) and Rep. Doris Matsui (D-Calif.) comes months before the expiration of temporary waivers first enacted by the DEA during the Covid-19 pandemic. Those rules are set to expire at the end of the year. More from Lev Facher and Mario Aguilar.
tobacco policy
People want to quit smoking. Where are we going wrong?
Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. Many argue that the smoking-cessation drugs on the market don't work well, and come with side effects and reputations that keep some smokers from ever trying them.
Despite this, there hasn't been a new class of drug approved for the condition in nearly two decades, Nicholas Florko reported in his last missive for STAT. It's a perfect storm of factors, advocates say: Drugmakers see brighter, more profitable prospects in other disease areas, and the FDA is historically skeptical of the smoking-cessation world.
With cigarette smoking killing tens of thousands of Americans a year, some of those advocates, former, and even current officials are turning up the pressure for FDA in particular. There's arguments that the agency set an impossibly high bar to find the next smoking-cessation product — and there's a meeting next month to hash it out. More from Nick.
FDA moves
Med device safety has a new face
The FDA tapped former device industry exec Ross Segan to lead its division charged with ensuring medical device safety, STAT's Lizzy Lawrence scooped Friday.
Segan has worked in the industry for years. He most recently served as chief medical officer for Olympus, an endoscope company with a long FDA history including warnings about product defects.
While it's not uncommon for industry leaders to join the agency, that track record has some advocates on guard as Segan takes over a complicated device safety portfolio. More from Lizzy.
drug pricing
Cassidy eyes exempting small biotechs from IRA plan
Sen. Bill Cassidy (La.) revealed a bill that would let some small drugmakers avoid President Biden's sweeping law to let Medicare directly negotiate drug prices, John scooped Friday.
The Inflation Reduction Act already exempts a set of biotechs from that plan. But that exemption expires after 2028, and only applies to drugs that were on the market in 2021. Cassidy's bill would extend those protections for longer and potentially include more biotech companies.
There's no chance, with a Democrat-controlled Senate and White House, that the bill gets traction this year. But with the election weeks away, Cassidy's legislation could be a preview of what's to come in a new Congress. More from John.
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