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Drugmakers may face stricter rules to ensure the supply of medicines in the European Union, EU officials said...as the bloc tries to reduce its imports of pharmaceutical products from China and other foreign "autocracies"...At the onset of the COVID-19 pandemic last year, the 27-country bloc encountered protracted problems in obtaining a wide range of medicines and their ingredients from India and China, as supplies tightened amid lockdowns and export restrictions...The planned rules change is also aimed at reducing the EU's reliance on medicine ingredients produced abroad, as the Commission estimates that two-thirds of the global supply is concentrated in India and China...READ MORE

After nearly nine months without a permanent FDA leader and after watching the agency withstand a torrent of criticism, President Joe Biden finally ready—almost—to announce a nominee for the beleaguered agency...Speaking to reporters on Tuesday in response to NIH Director Francis Collins’ retirement announcement, Biden said in reference to the FDA post, “We’ll be talking about that in a little bit.”...READ MORE

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

Pfizer’s efforts to blunt the anti-kickback policies...took a hit...as a federal district court dismissed its plan to assist Medicare patients in paying for one of the company's most expensive drugs...In ruling in favor of the Department of Health and Human Services...New York Judge Mary Kay Vyskocil denied Pfizer clearance to run two programs that would reimburse patients for their pricey heart medications Vyndaqel and Vyndamax, which cost $225,000 annually..."Because...the intent of the payments Pfizer proposes here are to increase the number of Medicare beneficiaries who purchase the drug, the Court is unable to issue the declaratory judgment Pfizer seeks or to issue judgment in its favor," Vyskocil wrote...The fight is an old one for Pfizer. In 2018, it had to cough up $24 million to settle a government lawsuit over donations to patient charities. The recent push was an attempt to challenge the laws that the company previously violated...READ MORE

...the US Department of Justice, three companies—Taro Pharmaceuticals, Sandoz, and Apotex—have agreed to fork over a total of $447.2m USD to settle their alleged violations of the False Claims Act. According to the government’s allegations, the firms conspired to fix the prices of various generic drugs, resulting in higher prices paid by federal health care programs and beneficiaries...The charges allege that between the years of 2013 and 2015, the trio of companies paid and received compensation, which is prohibited by the Anti-Kickback Statute, via arrangements on price, supply, and allocation of customers with other pharmaceutical manufacturers for certain generic drugs manufactured by the companies...READ MORE

Even while pediatric COVID-19 cases remain high in the United States, there remains significant resistance by parents to vaccinate their children. Amid this reluctance, Pfizer and BioNTech have asked the FDA to authorize their vaccine for children aged 5 to 11, the companies revealed...An FDA advisory committee has scheduled a meeting on Oct. 26 to discuss authorization. The submission potentially sets up the vaccine for emergency use approval...but the companies may face a tough sell trying to convince parents that the shot is safe...Last month, only 34% of parents in the U.S. with children ages 5 to 11 said they would vaccinate them “right away,”...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

...the Pharmaceutical Research and Manufacturers of America filed a complaint in the U.S. District Court for the Eastern District of Arkansas challenging provisions in Arkansas Act 1103 that seek to require manufacturers to provide federal 340B program pricing to Arkansas-based pharmacies contrary to federal statute...PhRMA...General Counsel James C. Stansel stated:“The 340B pricing mandate provisions of Arkansas Act 1103 violate both the Supremacy and Commerce clauses of the U.S. Constitution because they impermissibly clash with the statutory requirements of the federal 340B program. This misguided state mandate places requirements on manufacturers that directly conflict with the federal 340B statute and attempts to regulate commercial transactions that occur outside of Arkansas...READ MORE

The past several months have seen thousands of hospitals announce COVID-19 vaccination requirements for staff and clinicians as a condition of employment...Although controversial, the policies picked up steam when Pfizer and BioNTech’s Comirnaty received a full regulatory approval and then really kicked into gear when the Biden administration made workforce vaccination a requirement for Medicare and Medicaid participation...Most health system leaders and professional organizations have been supportive of the requirement, with some describing vaccination as “the logical fulfillment of the ethical commitment of all healthcare workers to put patients as well as residents of long-term care facilities first.”...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