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With pharmaceutical supply chains under immense pressure due to the novel coronavirus, China's role as a global ingredient producer has come under scrutiny. Despite fears the East Asian nation could shut off the tap for U.S. drugs, the FDA said it hasn't yet noticed major signs for concern...The FDA hasn't seen a shortage of active pharmaceutical ingredients (APIs) sourced from China due to the ongoing novel coronavirus outbreak but is "closely monitoring the situation," FDA Commissioner Stephen Hahn told Fox News...Hahn highlighted reported spot shortages of certain drugs due to increased demand but said China's API tap is still running, despite escalating rhetoric between the Chinese and U.S. governments. Hahn highlighted the Trump administration's push to develop "advanced" manufacturing stateside to help drive greater redundancy in the supply chain...READ MORE

FDA Commissioner Stephen Hahn offered more details of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak...While FDA inspections are suspended in China, the agency may ask firms for facility records ahead of or instead of inspections, allowing the agency to review records ahead of time and identify plants that most warrant an inspection...“These records will help the agency when we resume drug inspections in China,” allowing it to focus early inspections and help prevent an inspection backlog, he said...READ MORE

The U.S. Food and Drug Administration said it has been alerted to the first manufacturing shortage of an unnamed drug due to the deadly novel coronavirus outbreak that began in China and has now reached the U.S...FDA Commissioner Stephen Hahn said the agency has been "closely monitoring" the medical product supply chain "with the expectation" that the outbreak of the novel coronavirus would "likely" have an impact..."A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list," Hahn said in a statement Thursday night. "The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug."...READ MORE

A Biogen employee who allegedly concealed her coronavirus symptoms on a flight back to China may face criminal charges. But first, the biotech has decided it wants nothing to do with the rogue staffer...“She is no longer an employee of Biogen,” a company spokesperson told FiercePharma...According to Biogen, the former employee, a woman surnamed Li, ignored health experts’ guidance and “made the personal decision to travel to China without informing the company.”...Li told local authorities she attended the ill-fated Biogen management meeting at the Marriott Long Wharf hotel in Boston on Feb. 26 and Feb. 27, which as of Thursday has been linked to 97 COVID-19 cases in Massachusetts and multiple cases in other states. But the people at Biogen said Li did not attend the meeting because it wasn't an event for her...READ MORE

The new coronavirus outbreak may be very bad for your health but not only for the reasons you imagined. This coronavirus is less likely to harm you directly than to injure you through its impact on your other medical needs...COVID-19 is more likely to harm Americans indirectly because the U.S. is increasingly reliant on drugs either directly sourced from China or made from intermediate chemicals...While 90 percent of the finished drugs Americans take are generics, most are manufactured overseas, primarily in India and China. Even India...relies on China for 80 percent of the APIs it uses in drug production...COVID-19 has resulted in massive disruption of Chinese manufacturing. It’s only a matter of time until this translates into supply disruptions for China-dependent customers...Coronavirus has created concerns about not only the quantity of Chinese medical products available but also about the virus’s effect on quality. China does not effectively regulate Chinese drug manufacturers. Multiple episodes have cast doubt on the safety and efficacy of their products...READ MORE

The number of new coronavirus infections inside China - the source of the outbreak - was for the first time overtaken by fresh cases elsewhere...as U.S. markets turned negative on fears over the rapid global spread of the disease...Asia reported hundreds of new cases, Brazil confirmed Latin America’s first infection and the new disease - COVID-19 - also hit Pakistan, Greece and Algeria. Global food conglomerate Nestle suspended all business travel...U.S. health authorities, managing 59 cases so far - mostly Americans repatriated from a cruise ship in Japan - have said a global pandemic is likely…Stock markets across the world have lost $3.3 trillion of value in four days of trading, as measured by the MSCI all-country index...Wall Street reversed earlier gains on Wednesday afternoon on fears that the virus would spread across the United States, and oil prices dropped to their lowest level in over a year...READ MORE

Some patients infected with the novel coronavirus can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. After seeing promising results in clinical practice, Chinese authorities now recommend a Roche arthritis drug to tackle that rampage...Roche’s blockbuster Actemra, first approved by the U.S. FDA in 2010 for rheumatoid arthritis, can now be used to treat serious coronavirus patients with lung damage, China’s National Health Commission said in its updated treatment guidelines for COVID-19...READ MORE

Cardinal Health paid the SEC $8.8 million Friday to settle FCPA (Foreign Corrupt Practices Act) offenses related to a Chinese subsidiary that provided marketing services...In an internal administrative order, the SEC charged Cardinal Health with violating the FCPA’s books and records and internal accounting controls provisions...Dublin, Ohio-based Cardinal Health agreed to disgorged $5.4 million to the SEC, plus prejudgment interest of $916,887, and pay a civil penalty of $2.5 million...In one instance, a marketing account it administered for a UK- based pharmaceutical manufacturer was terminated in 2013 after Cardinal’s CEO received an internal report alleging that Cardinal China employees were using the account to “bribe employees of China’s Center for Disease Control.”...READ MORE

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