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On arrival for a pre-approval inspection for a Chinese heparin API maker, an FDA inspector was told that the plant had not started making products and was only doing equipment testing. The truth of the matter was hidden in a drum being snuck out the back. An intercepted container an employee was removing from the warehouse contained two batches of crude heparin manufactured two days earlier...That was just the beginning of the problems found during July 2019 inspection of Yibin Lihao Bio-technical, the API maker in Yibin Shi Sichuan, China. According to a warning letter, there were quality assurance records scattered in cabinets, on desks and on the floor of the QA office. Employees insisted they were for a grant application from the government and not manufactured products. Not true. The FDA would learn the records did correspond to manufactured heparin...READ MORE

At the beginning of 2019, ...the…Food and Drug Administration began accepting pilot project proposals to identify solutions for meeting the 2023 requirements of the Drug Supply Chain and Security Act. The…Congress passed the DSCSA to improve the security of the pharmaceutical supply chain to help eliminate counterfeit pharmaceuticals and enhance patient safety...the MediLedger Project, a working group of 24 industry leading pharmaceutical manufacturers, distributors, retail chains, logistics partners and solution providers, was accepted by the FDA as one of their approved proposals…The working group’s purpose was to evaluate blockchain technology…in the track and trace of prescription medicines in the United States. The MediLedger Project released…the MediLedger DSCSA Pilot Project Final Report detailing how and why blockchain can meet the 2023 DSCSA requirements for an interoperable, confidential change of ownership system in the US pharmaceutical supply chain…READ MORE

The surge in vertical integration in the healthcare industry has created "an oligopoly of integrated healthcare companies controlling nearly all aspects of the healthcare and pharmacy supply chain," said the National Community Pharmacists Association in comments submitted today to the Federal Trade Commission and the US Department of Justice Antitrust Division..."These vertical mergers have allowed a handful of massive companies to exercise enormous power over patients and the marketplace. In many cases, we believe they are creating for themselves unfair advantages that are driving up patient costs and killing local businesses," said B. Douglas Hoey, NCPA CEO...READ MORE

Twenty one states have rejected an $18 billion settlement proposal from three major U.S. drug distributors to resolve lawsuits over their alleged role in the opioid crisis, but discussion are still active...More than 2,500 lawsuits have been brought nationwide by states, local and tribal governments over the toll the opioid crisis has taken on their communities...the states objected to a settlement offer sent to the companies’ law firms earlier this week, and were pushing for a larger payment...READ MORE

The federal government has released its long-awaited plan to reduce red tape and other administration snarls that create time-eating obstacles for doctors using health information technology...The Department of Health and Human Services' Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs, mandated by the 21st Century Cures Act, aims to reduce the effort and time required by clinicians to meet reporting requirements, record health information, and improve the functionality and intuitiveness of EHRs...READ MORE

Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network

The Food and Drug Administration...outlined its efforts to track potential supply chain disruptions emanating from the spread of the new coronavirus from China, noting increased ordering of surgical masks, gowns and other personal protective equipment through distributors...Agency chief Stephen Hahn said in a statement that shifting ordering patterns has yet to result in shortages but warned the situation is "evolving and very dynamic."...The agency is holding off on conducting medical product inspections in China, heeding the State Department's warning against traveling to the country where the outbreak began. Still, Hahn noted the FDA is working to use other information "to inform decisions allowing the products to enter the U.S. market."...READ MORE

In Nevada, there have been no cases of the coronavirus, but in California there have been eight confirmed cases. Public health officials in the Silver State are closely monitoring the outbreak...Dr. Mark Pandori is the director of the Nevada State Public Health Laboratory. He said they are prepared if there were to be an outbreak in the state, and are actively gathering information from California...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Spread of the novel coronavirus in China and beyond would have mixed effects on U.S. biopharma companies, says Moody's...the impact on their businesses may be mixed...If the virus persists long enough, branded drugmakers may see decreased demand for their innovative drugs in China...the global spread of the virus could lead to government stockpiling of certain drugs such as antivirals...As for generic players, which depend on China for active pharmaceutical ingredients, a continued outbreak may increase the risk of supply disruption...READ MORE