Morning Briefing
Summaries of health policy coverage from major news organizations
New Rule From DEA, HHS Will Allow Some Opioid Treatment Via Telehealth
The Biden administration Wednesday finalized a long-awaited rule laying out how some health care providers can prescribe gold-standard opioid use disorder treatments through telehealth. (Hellmann and Raman, 1/15)
In other pharmaceutical developments —
On Wednesday, the FDA issued its long-awaited proposal to drastically limit the amount of nicotine in cigarettes and some other tobacco products, with the goal of making them less addictive. In its proposed rule, the FDA would cap the nicotine level at 0.7 mg/g of tobacco in cigarettes and certain other combusted tobacco products. The FDA's proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco -- not e-cigarettes, nicotine pouches, noncombusted cigarettes, waterpipe tobacco, and smokeless tobacco products. (Lou, 1/15)
After years of sparring, the Biden administration and Gilead Sciences have settled a contentious lawsuit over patents for a pair of HIV prevention pills in a case that raised questions about the extent to which government-funded research should lead to affordably priced medicines. (Silverman, 1/15)
A new report from HHS' Office of Inspector General raises concerns about the FDA's accelerated approval process for drugs with weak supporting evidence, Bloomberg reported Jan. 14. The report highlights issues with the approvals of Biogen's Alzheimer treatment, Aduhelm; Serepta Therapeutics' Duchenne muscular dystrophy therapy, Exondys 51; and Covis Pharma's preterm birth prevention treatment, Makena. (Murphy, 1/15)
Maricruz Salgado was bringing her diabetes under control. Thanks to a federal program that allowed health clinics that serve poor people to buy drugs at steeply discounted prices, she was able to pay less than $75 for all five of her diabetes medications every three months. But in July, the cost of three of those drugs soared. Ms. Salgado, who does not have health insurance, suddenly faced costs of hundreds of dollars per month. She could not afford it. (Thomas, 1/16)