New Rule From DEA, HHS Will Allow Some Opioid Treatment Via Telehealth
Roll Call reports that the newly finalized rule will allow for health care providers who have not seen a patient in person to prescribe six months’ worth of buprenorphine via telehealth. Also in pharma news: FDA's proposed nicotine crackdown; FDA's fast-track approval process for drugs; insulin prices; and more.
Roll Call:
DEA, HHS Finalize Rule Allowing Telehealth Drug Treatment
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 —
MedPage Today:
FDA Finally Proposes A Nicotine Crackdown, Years In The Making
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)
Stat:
Biden Administration, Gilead Settle Battle Over Patents For HIV PrEP Pills
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)
Becker's Hospital Review:
Watchdog Flags Flaws In FDA's Fast-Track Drug Approvals
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)
The New York Times:
Insulin Prices Dropped. But Some Poor Patients Are Paying More
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)
