- Supreme Court maintains access to abortion pill, blocking restrictions on its use (biopharmadive.com)
The stay suspends an order by a Texas judge that had invalidated the FDA’s approval of mifepristone, keeping it available while a circuit court hears the case...The Supreme Court on Friday allowed the abortion pill mifepristone to remain on the market for the time being, suspending a lower court order that would have curtailed its availability in the U.S....The 7-2 ruling stays a verdict earlier this month by U.S. District Court Judge Matthew Kacsmaryk invalidating the Food and Drug Administration’s 2000 approval of mifepristone. Justices Samuel Alito and Clarence Thomas dissented...READ MORE
- As US drug shortages persist, House committee presses FDA for answers (fiercepharma.com)
With drug shortages becoming increasingly common...House Republicans are pressing the FDA for answers. At the heart of the investigation is whether the FDA has done enough to prevent and respond to the current spate of shortfalls, which have affected cancer meds and nonprescription painkillers alike...In a letter...Republican leaders from the House Committee on Energy and Commerce pressed FDA Commissioner...to respond 10 questions on the FDA’s tracking of scarce medicines, its inspection priorities and what the agency has done to parse and prevent shortages...READ MORE
- Walgreens won’t sell abortion pills in GOP states after legal threats from state officials (fiercehealthcare.com)
Walgreens will not dispense abortion pills in nearly two dozen states after legal threats from GOP lawmakers, the retail pharmacy chain confirmed...The Walgreens decision stems from a letter written by nearly two dozen Republican state attorneys general at the beginning of February that threatened legal action if the company began distributing mifepristone in their states...Walgreens...spokesperson saying “we are not distributing mifepristone at this time. We intend to be a certified pharmacy and will distribute mifepristone only in those jurisdictions where it is legal and operationally feasible.”...READ MORE
- State board reports hundreds of pending Nevada MD complaints (apnews.com)Some Nevada Medical Board investigations dragging on for seven years, records show (mynews4.com)
KRNV-TV reported...that in response to a public records request, the board said it has 455 pending cases, including three on hold since 2016 because police also are investigating...Medical Board Executive Director Ed Cousineau told KRNV-TV that staffing issues can make it difficult to complete investigations in a timely manner...But Reno attorney Julie Throop said delays of seven years can make it too late for attorneys to use board findings in court...KRNV-TV said records showed 301 pending complaints filed against doctors last year and 140 unresolved since 2019. It found eight outstanding complaints from 2018 and three from 2017...READ MORE
- Emergent makes history with first FDA nod for over-the-counter naloxone (fiercepharma.com)
...the FDA approved the first over-the-counter naloxone product...the U.S.’ drug regulator blessed Emergent’s 4mg Narcan nasal spray with a nonprescription nod, teeing up direct-to-consumer sales at places like drug stores, convenience stores, supermarkets and gas stations...the timeline on which the product will be made available at stores—as well as its price—is up to Emergent...Other formulations and dosages of naloxone will remain prescription only, though there are access laws that technically permit pharmacies across all 50 states to dispense the emergency drug without a doctor’s note...READ MORE
- Las Vegas, Las Vegas Strip Have An Unexpected Cannabis Problem (thestreet.com)Nevada cannabis lounges stoke DUI fears as fatal crashes rise (reviewjournal.com)
When Nevada legalized recreational cannabis, people expected the normal array of problems as Las Vegas tourists over-indulged...Legalized cannabis, however, has come with its own set of unique problems. First and foremost casino operators including the Las Vegas Strip's biggest operators...Since they're regulated by federal law, casino operators can't house dispensaries or Las Vegas's newly-approved cannabis lounges. That means that people not only have to leave their Strip or downtown resort in order to buy marijuana, but they also have to leave to legally smoke it...that quirk in the law keeps tourists from smoking and driving. That could change later this year when new rules allow dispensaries like Planet 13 to add consumption lounges to their locations...READ MORE
- DEA’s proposed telehealth rules pull back COVID-era remote prescribing flexibilities (fiercehealthcare.com)
Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration...If made permanent, the rules would be a marked change from the suspension of the Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic...Under the proposed rule released by the DEA...some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder would require at least one in-person visit...READ MORE
- Bipartisan caucus in US Congress looks to boost domestic drug manufacturing (fiercepharma.com)
...the Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress...will focus on domestic production of finished drugs and active pharmaceutical ingredients...Members of the caucus said they will look to advance legislation that incentivizes more domestic production for essential medicines as part of an effort to reduce U.S. reliance on foreign countries. The lawmakers also aim to head off potential supply chain disruptions and ensure a steady supply of pharmaceuticals in the event of public health emergencies...READ MORE
- Teladoc-owned BetterHelp to pay $7.8M to online therapy users for alleged data misuse, per FTC order (fiercehealthcare.com)
The Federal Trade Commission has reached a settlement with online therapy company BetterHelp...over allegations that it shared consumers’ health data with companies like Facebook and Snapchat for advertising purposes...BetterHelp is banned from sharing consumers’ health data, including sensitive information about mental health challenges, with third parties for marketing and ad targeting...BetterHelp also agreed to pay $7.8 million to consumers to settle charges that it revealed consumers’ sensitive data with third parties for advertising after promising to keep such data private...READ MORE
- All Nevada counties will see proceeds from opioid settlements (thenevadaindependent.com)
After receiving more than $320 million so far from settlements with opioid companies, the state has created a process to divide it across all Nevada counties...the attorney general’s office debriefed members of the Assembly Committee on Revenue on the One Nevada Agreement on Allocation of Opioid Recoveries...“We included all counties — whether or not they were litigating or non-litigating — so that they all are receiving something because frankly, this opioid epidemic does not care about county lines or city lines,” said Chief Deputy Attorney General Mark Krueger...One of the more recent settlements was $32 million the state received through opioid litigation with Walmart...READ MORE