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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

The White House announced the launch of the first federally supported test-to-treat site, a part of the White House test-to-treat initiative designed to improve access to COVID-19 antiviral oral medications for certain high-risk patients. In response, ASHP sent a letter to Ashish Jha, the White House COVID-19 Response Coordinator, requesting the administration dramatically expand access to COVID-19 antivirals in all communities by removing the federal barrier preventing pharmacists from initiating therapy with these time-sensitive medications...READ MORE

The city of Las Vegas contracted with Northshore Clinical Labs to provide limited COVID-19 testing early this year, a city representative said this week...“This was when demand for testing was at its highest levels, and the city was trying to help meet that demand,” city representative Jace Radke said in an email. “The city has not entered into any other contracts with Northshore Clinical Labs, and is no longer affiliated with the company.”...Northshore was the target of a ProPublica investigation that revealed...the lab’s tests frequently gave inaccurate results. A test by the Nevada State Public Health Laboratory found a false-negative rate of 96 percent, meaning that Northshore’s test had missed nearly all positive cases in the sampling...READ MORE

The Food and Drug Administration has determined that the risk of a rare, but serious, clotting syndrome tied to Johnson & Johnson’s COVID-19 vaccine warrants limiting its use to adults who either can’t or won’t get another available shot...The agency is taking stricter measures following a new analysis...has uncovered 60 known cases of the side effect, nine of which were fatal. The overall rates remain very low — about 3.23 cases per million vaccinations with J&J’s shot and 0.48 deaths per million. Regulators still aren’t sure exactly which factors put people at risk for the disorder, which initially appeared most common in younger women. It isn’t associated with either Pfizer’s or Moderna’s vaccines...READ MORE

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

Federal authorities are expanding an investigation into Chicago-based Northshore Clinical Labs following a ProPublica story that raised questions about its COVID-19 testing operations in Nevada...an investigator with the Inspector General’s Office of the U.S. Department of Health and Human Services indicated he planned to subpoena documents from Nevada health officials...“Myself and other law enforcement agencies have had a case opened regarding Northshore Clinical Lab for quite some time,” wrote Special Agent Peter Theiler, who is based in Chicago. “After reading the ProPublica article on Northshore Clinical Lab regarding Nevada patients, we are interested in obtaining records related to testing for COVID-19 for Northshore Clinical Lab rapid test results and PCR test results for Nevada.”...READ MORE

No one who provides a service does it for free. Professionals administer these services, and payment is expected...Have you heard about the uninsured person who walked into the pharmacy to get their second or third or fourth COVID-19 shot? The billing mechanism for these patients—the Health Resources and Services Administration—is now out of money, and yet we, the pharmacists, are expected to take care of these patients...According to the CDC website,“[The] COVID-19 vaccine is free of charge for everyone. Participating pharmacies will bill private and public insurance for the vaccine administration fee. For uninsured patients, this fee will be reimbursed through the Health Resources and Services Administration’s Provider Relief Fund.”...At least half the patients who come into the pharmacy will ask why we need their insurance card. “These shots are supposed to be free,” they say. I explain to them that it takes at least 15 minutes of our time to administer a shot, and even though the vaccine is “free”—and even the alcohol pads and syringes are “free”—there is still a cost...READ MORE

The role of pharmacy technicians in immunizations has evolved rapidly, particularly over the past 2 years because of COVID-19. Prior to the pandemic, pharmacy technicians for the most part were limited to assisting pharmacists in basic tasks related to immunizations. These included screening patients, preparing for the immunization, and performing administrative tasks required for immunization programs...In 2016, Idaho led the way in expanding the role of pharmacy technicians to include administering immunizations...the results were clear: All pharmacy technicians taking part in the study passed their assessments on the first attempt...The momentum for pharmacy technician-administered immunizations continued in Michigan, Washington state, Rhode Island, Utah, and Nevada...READ MORE

Jose Maria Fernandez Sousa-Faro, president of European pharmaceuticals giant PharmaMar, has been charged by police with being falsely vaccinated against Covid-19. Dr. Sousa-Faro has been caught up in a scandal in Europe involving people being added to the National Immunization Registry in exchange for large sums of money...Police allege that Sousa-Faro arranged to be injected with a saline solution instead of a Covid-19 vaccination and paid thousands of dollars to have his name added to Spain's immunization register, as confirmed by police sources and reported by El Periodico de Espana...READ MORE

In its COVID-19 vaccine patent kerfuffle with Arbutus Biopharma and Roivant’s Genevant Sciences, mRNA hot shot Moderna aims to shield itself with its government contract...Plaintiffs Arbutus and Genevant sued Moderna back in February, seeking damages tied to six patents they claim Moderna infringed with the production and sale of its COVID-19 vaccine Spikevax...the plaintiffs should have sued the U.S. government instead, Moderna said in a filing at the U.S. District Court for Delaware. To back up its argument, Moderna cited a federal law once used to “’prevent patent infringement suits from interfering with the supply of war materials during World War 1.'”...Moderna explained that it supplied its COVID-19 vaccine to the feds as part of the nation’s emergency response to the pandemic. It's "difficult to conceive of a situation more within the heart" of the wartime law than the pandemic, the company argued...READ MORE