Category:

Pharmacy operators including CVS Health Corp and Walmart Inc fueled the U.S. opioid epidemic by failing to stop massive quantities of addictive painkillers from reaching the black market, a lawyer for two Ohio counties said at the start of a trial...Mark Lanier told a federal jury in Cleveland hearing the first trial the pharmacy chains have faced in nationwide litigation over the epidemic that the companies bore responsibility for drug abuse in the counties of Lake and Trumbull..."They just dispensed like a vending machine," Lanier said in his opening statement...READ MORE

A landmark opioid trial is getting underway in Cleveland. For the first time, pharmacies...will be on trial, and there will be far-reaching implications for big-ticket policy questions far afield of the opioid crisis...On one side will be Walgreens, CVS, and Walmart. On the other, two Ohio counties...The basic theory that will be trial-tested is whether pharmacies are legally responsible for creating a public nuisance by overlooking so-called “red flags” when filling customers’ prescriptions for FDA-approved opioids...READ MORE

Pfizer...announced that the U.S. Food and Drug Administration has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series...READ MORE

Ahead of a highly anticipated meeting that could influence how soon coronavirus booster shots become widely available in the U.S., staff at the Food and Drug Administration appeared to take a neutral view of whether the agency should authorize a third dose of Pfizer's vaccine..."Some observational studies have suggested declining efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not," the reviewers said in the document, using the brand name for Pfizer's vaccine. "[B]ut FDA has not independently reviewed or verified the underlying data or their conclusions."...READ MORE

The...Supreme Court...cleared the way for New York to collect a $200 million surcharge imposed on opioid manufacturers and distributors to defray the state's costs arising from the deadly epidemic involving the powerful painkilling drugs...The justices declined to hear an appeal by two trade groups representing drug distributors and generic drug makers and a unit of British-based pharmaceutical company Mallinckrodt Plc of a lower court's decision upholding the surcharge...The law's challengers included the Association for Accessible Medicines, whose members include drugmakers Teva Pharmaceutical Industries Plc...and Mallinckrodt, and the Healthcare Distribution Alliance, which represents wholesale distributors...The alliance's members include the three largest opioid distributors in the United States, McKesson Corp, AmerisourceBergen Corp and Cardinal Health...READ MORE

New York hospitals on Monday began firing or suspending healthcare workers for defying a state order to get the COVID-19 vaccine, and resulting staff shortages prompted some hospitals to postpone elective surgeries or curtail services...New York City Mayor Bill de Blasio told a news conference the city's hospitals were not yet seeing a major impact from the mandate, adding he worried about other areas of the state where vaccination rates are lower...A spokeswoman for Catholic Health, one of the largest healthcare providers in Western New York, said it had reached full compliance, counting staff members who had been vaccinated, those with exemptions and some who had been suspended without pay...READ MORE

Results from a new HDA Research Foundation survey indicate that the pharmaceutical supply chain is entering a critical phase in achieving the transaction data connections required to comply with the Drug Supply Chain Security Act in 2023...The DSCSA requires transaction data with product identifiers to be provided with physical product on November 27, 2023...“many healthcare supply chain trading partners are realizing there is work to be done to establish proper business-to-business connections; ensure data are formatted, transmitted and received successfully; that processes for troubleshooting are created; and that products in inventory have the right data attached to them for shipping after November 27,” said Perry Fri...COO of the HDA Research Foundation. “The Foundation’s survey shows...what might be leading to slow implementation rates across the supply chain.”...READ MORE

Five weeks after Japan suspended the use of three lots of the Moderna COVID-19 vaccine, the company and its Japanese distributor Takeda have concluded that “human error” caused the presence of metallic particles in vials...The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The fourth and fifth lots from the series were held back...READ MORE

Businesses with 100 or more employees will be required to mandate vaccination or weekly testing for their workers under a new rule announced by President Joe Biden...But many Nevada businesses and public institutions have already put their own employee vaccine mandates in place, with more in the works as the federal government finalizes the new rule and fleshes out its finer points. Some have gone further by requiring vaccinations not just for employees but as a condition of entry for members of the public, including at conventions, athletic events and concerts...At the same time, some rural governments have passed resolutions banning vaccine mandates to varying degrees...READ MORE

An FDA advisory panel knocked down Pfizer and BioNTech's pitch for COVID-19 booster shots for everyone, but rebounded on the committee's follow-up allowance for third shots in the elderly and high-risk people...he committee voted 16-2 to reject Pfizer’s bid for a full approval for boosters for people 16 and older...“It may eventually be indicated for the general population,” committee member Ofer Levy, M.D, said. “I just don’t think we’re there yet in terms of the data.”...READ MORE