- 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
- Senators blast Pfizer’s proposed COVID vaccine price hike as ‘profiteering’ (fiercepharma.com)
With the era of free COVID-19 vaccines winding down in the U.S., lawmakers are pressing Pfizer for a fair Comirnaty price tag and singling out the pharma giant for its “unseemly profiteering.”...Sen. Elizabeth Warren of Massachusetts and Vermont Sen.-elect Peter Welch blasted Pfizer’s purported Comirnaty pricing scheme—which could see the company charge between $110 and $130 per vaccine dose on the private market—as “pure and deadly greed.”...To date, more than 650 million COVID-19 vaccine doses have been administered in the U.S...Warren and Welch explained. But that “public health achievement” is “now at risk” thanks to Pfizer’s greed, they warned...READ MORE
- Nevada pharmacists allowed to prescribe Pfizer’s COVID-19 pill (reviewjournal.com)FDA is letting pharmacists prescribe Pfizer's Paxlovid but won't do the same for Merck's Lagevrio (fiercepharma.com)
...the U.S. Food and Drug Administration took the unusual step of authorizing pharmacists to directly prescribe antiviral medication Paxlovid to patients testing positive for COVID-19...But don’t expect to get a prescription right away from your neighborhood pharmacist for the pills...Major pharmacy chains and a state regulatory agency said Friday that they’re continuing to work with the FDA on how to best implement the change, including whether any new costs will be passed on to patients. Although the details still need to be worked out, the change was applauded by the industry...“I’m elated,” said Christina Madison, an associate professor at the College of Pharmacy at Roseman University in Southern Nevada...The change eliminates a barrier to getting treatment, especially in rural areas and “medical deserts” where a pharmacy is “the only place a person can get medical information for miles,” she said...READ MORE
- Pfizer stock-owning judges play musical chairs in New York City vaccine mandate lawsuits (fiercepharma.com)Judge Caproni Recuses Herself from NYC Vaccine Mandate Lawsuit because she owns Pfizer stock (teachersforchoice.org)
What do you do when you can’t find a judge who doesn’t own Pfizer stock? Keep looking. Then look again—and again...Such was plaintiffs’ plight this week in two consolidated federal lawsuits taking aim at the New York City Department of Education’s COVID-19 vaccine mandates. Since Monday, two judges have come and gone, thanks to their financial ties to pandemic vaccine companies. Meanwhile, a third has vowed to stick around, arguing her investments in Pfizer and Johnson & Johnson are out of date...READ MORE
- China reopens borders in final farewell to zero-COVID (reuters.com)
Travellers began streaming into mainland China by air, land and sea on Sunday, many eager for long-awaited reunions, as Beijing opened borders that have been all but shut since the start of the COVID-19 pandemic...After three years, mainland China opened sea and land crossings with Hong Kong and ended a requirement for incoming travellers to quarantine, dismantling a final pillar of a zero-COVID policy that had shielded China's people from the virus but also cut them off from the rest of the world...READ MORE
- Moderna refused China request to reveal vaccine technology, Financial Times reports (reuters.com)A Chinese mRNA COVID vaccine is approved for the first time - in Indonesia (reuters.com)
Moderna Inc has refused to hand over to China the core intellectual property behind the development of its COVID-19 vaccine, leading to a collapse in negotiations on its sale there...the vaccine maker is still “eager” to sell the product to China...READ MORE
- CDC and FDA clear the way for COVID vaccines for kids under 5 (cbsnews.com)Florida Gov. Ron DeSantis: ‘We are not going to order’ vaccines for kids for state health departments (msn.com)
Some 20 million babies, toddlers, and preschoolers are now eligible to be vaccinated for COVID-19, after the Centers for Disease Control and Prevention's Director Dr. Rochelle Walensky signed off on unanimous votes from her agency's outside vaccine advisers to recommend shots from Moderna as well as Pfizer and BioNTech for children as young as six months old..."Together, with science leading the charge, we have taken another important step forward in our nation's fight against COVID-19," Walensky said...READ MORE
- In Beijing, funeral homes and crematoriums are busy as COVID spreads (reuters.com)
Hearses bearing the dead lined the driveway to a designated COVID-19 crematorium in the Chinese capital on Saturday while workers at the city's dozen funeral homes were busier than normal, days after China reversed tight pandemic restrictions...In recent days in Beijing the spread of the highly transmissible Omicron variant has hit services from catering to parcel deliveries. Funeral homes and crematoriums across the city of 22 million are also struggling to keep up with demand as more workers and drivers testing positive for coronavirus call in sick...China is yet to officially report any COVID deaths since Dec. 7 when the country abruptly ended many key tenets of its zero-COVID policy that had been championed by President Xi Jinping, following unprecedented public protests against the protocol...READ MORE
- Group of 23 states tells U.S. court CDC lacks authority to set transit mask rules (reuters.com)
A group of 23 state attorneys general led by Florida told a federal court on Monday that the U.S. Centers for Disease Control and Prevention lacks the legal authority to impose a nationwide transportation mask mandate to address COVID-19...The CDC sought "an unprecedented masking mandate regulating every breath of millions of Americans," said the brief in support of the group that sued to overturn the mask mandate...The group, which included Arizona, Georgia, Indiana, Missouri, Ohio, Texas and Virginia, urged the appeals court to reject the CDC "overreach."...READ MORE
- FDA’s drug manufacturing oversight lags as pandemic wears on (fiercepharma.com)The FDA’s Weak Drug Manufacturing Oversight a Potentially Deadly Problem (ien.com)
Two and a half years in, the COVID-19 pandemic continues to drag on the FDA’s oversight of drug manufacturing plants...In fiscal year 2021, the FDA sent out 70% of follow-up letters to manufacturing facilities within 90 days of an inspection. Over that same stretch, the regulator completed 48% of regulatory actions for facilities in need of follow-up within six months of inspection closing, the agency said in a new report...To put those stats in perspective, the agency in fiscal year 2020 sent 78% of classification letters within the 90-day time frame and knocked out 63% of regulatory actions required over a six-month span. And in 2019, it sent out 87% of letters and completed 74% of regulatory actions during those time frames...READ MORE