Juul Sues FDA For Withholding Scientific Reviews Behind E-Cig Ban
The e-cigarette maker's complaint says the FDA is violating the Freedom of Information Act, Axios reports. In other news, Walgreens acquires Shields Health Solutions, CRISPR gene editing is said to be getting harder, West Virginia announces an opioid settlement, and more.
Axios:
Juul Sues FDA Over Documents Supporting E-Cigarette Ban
Juul Labs on Tuesday filed a lawsuit against the Food and Drug Administration over the agency's refusal to disclose documents supporting its order to take Juul's e-cigarettes off the shelves in the U.S. market. (Ravipati, 9/20)
Modern Healthcare:
Walgreens To Acquire Shields Health Solutions
Walgreens Boots Alliance has agreed to spend $1.37 billion to acquire the remaining 30% of specialty pharmacy company Shields Health Solutions that it didn't already own. In September 2021, Walgreens spent $970 million to become a majority stakeholder in Shields, and the company will acquire the remaining stake from other equity holders. The transaction is expected to close by the end of 2022, the companies said Tuesday. (Devereaux, 9/20)
Stat:
After Early Wins, CRISPR Gene Editing Is About To Get A Lot Harder
The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their liver last year, another six patients with a different strand of toxic liver DNA knocked out last week. The next era of CRISPR may not be so smooth. (Mast, 9/21)
KHN:
Genetic Tests Create Treatment Opportunities And Confusion For Breast Cancer Patients
The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment. But the clinical significance of many of the inherited mutations that can now be identified remains unclear, and experts are torn on when and how to deploy all the new tests available. Patients are sometimes left paying out-of-pocket for exams that are not yet the standard of care, and even the most up-to-date oncologists may be uncertain how to incorporate the flood of new information into what used to be standard treatment protocols. (Andrews, 9/21)
On opioids and drug use —
AP:
W.Va. Announces $147M Opioid Settlement With CVS, Walmart
Walmart and CVS Pharmacy have settled with the state of West Virginia for a combined total of $147 million in a lawsuit over the companies’ roles in contributing to the oversupply of prescription drugs that fueled the opioid epidemic in the country’s most impacted state, Attorney General Patrick Morrisey announced Tuesday. Walmart and CVS were two lawsuits that were part of a larger trial that was pushed back to June of next year along with Kroger and Walgreens. Morrisey recently announced a settlement with Rite Aid for up to $30 million to resolve similar litigation. (Willingham, 9/20)
Stat:
To Stem Overdoses, Canada Is Offering Safer Opioids. Will The U.S., Too?
Jouvence Tshiyoyo Bukumba, a nurse, asked Kim, 46, about her cardiology appointment and Chris, 54, about his nerve pain. Then came “the SOS questions” — safer opioid supply. How were their doses? Did they feel any cravings or withdrawal? (Joseph, 9/21)
USA Today:
Aaron Rodgers Insists Ayahuasca Is 'Not A Drug' And Says He May Be 'Called' To Take It Again
According to the Alcohol and Drug Foundation, ayahuasca is a liquid-based psychedelic that can cause a person to hallucinate. The active chemical in ayahuasca is dimethyltryptamine (DMT). DMT is a Schedule I controlled substance in the United States, which means it is illegal to manufacture, buy, possess, or distribute the drug. (Kuhagen, 9/20)