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Amid efforts to close a $1.6 billion opioid settlement, Mallinckrodt has fought tooth and nail to escape a massive Medicaid rebate bill for its controversial H.P. Acthar Gel. Instead of ceding ground, the U.S. government opted to take the fight right back to Mallinckrodt––and it could create even more trouble for the embattled drugmaker...The federal government has joined a False Claims Act whistleblower suit filed in Boston accusing Mallinckrodt of underpaying Medicaid rebates for Acthar by "hundreds of millions of dollars,"...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

A federal probe of pharma’s charity contributions has secured settlements from drugmakers large and small, and Sanofi is the latest to ink a deal with the government over allegations its payments were kickbacks...Sanofi agreed to pay $11.85 million to resolve allegations that it used The Assistance Fund as a “conduit” to help multiple sclerosis patients pay their Medicare co-pays for Lemtrada...The drug costs nearly $100,000 per year, and patient co-pays can run thousands of dollars per year...“Sanofi sought to undermine the Medicare program through its use of kickbacks disguised as routine charitable donations aimed at helping patients battling multiple sclerosis and who were struggling with costly copays,”...READ MORE

Lawsuits over Medicaid rebates are a fact of life in pharma, and in one particularly long-running case, Bristol-Myers Squibb stands accused of fiddling with its prices to lower payments. Now, after seven years in litigation, that lawsuit could be nearing an end...Bristol reached an "agreement in principle" in January to settle a 2013 whistleblower lawsuit accusing the company of manipulating the average manufacture price of its drugs in order to underpay Medicaid rebates between 2007 and 2016, according to an SEC filing...READ MORE

Is the pharma industry hiking up drug prices to boost profitability at the expense of hardworking Americans? That question—a favorite of politicians on both sides of the aisle—is at the heart of a special issue of the Journal of the American Medical Association, which features a collection of articles that aim to provide a well-rounded answer...Perhaps the most damning of the studies compares the profits of the 35 biggest pharmaceutical companies to the S&P 500 as a whole. The study...found that between 2000 and 2018 the median annual gross profit margin of Big Pharma was 76.5%, versus just 37.4% for the S&P 500 companies. Earnings before taxes and net income margins were also significantly higher among pharma companies, the authors reported...Merck CEO Kenneth Frazier had his own set of worries about the new JAMA studies, though he was more focused on fairness—or lack thereof...READ MORE

When federal prosecutors nabbed a guilty plea from a former exec at Novartis' Sandoz in an expansive price-fixing probe, it seemed to spell trouble for the massive generics player. Now, the other shoe has dropped for Novartis—to the tune of $195 million and an extraordinary confession—and more could be on the way...Novartis agreed Tuesday to pay $195 million and enter deferred prosecution to settle federal claims it colluded in an industrywide price-fixing scheme between 2013 and 2015...The criminal settlement is the single largest domestic antitrust deal ever signed....and it comes two weeks after a former Sandoz unit exec pleaded guilty to federal conspiracy charges in the scheme...READ MORE

The roles that pharmacists in community, hospital and clinical biology can play in preventing the spread of the new coronavirus 2019-nCoV and supporting the efficient management of infection by healthcare systems are outlined in a new document published by the International Pharmaceutical Federation (FIP) today. The document was developed by an emergency taskforce set up by FIP following the World Health Organization’s declaration that the outbreak of 2019-nCoV constitutes a public health emergency of international concern...READ MORE

Personalized medicine is the future of medical progress...For instance, an immunotherapy treatment called chimeric antigen receptor T-cell therapy is accessible now, and the Trump administration has the opportunity to make it widely available to Medicare beneficiaries...over 70 Members of Congress—Democrats, Republicans, liberals, and conservatives—sent a letter to Seema Verma, administrator of the Centers for Medicare and Medicaid Services, commending the administration for “ensuring Medicare patients nationwide have access” to this life-saving treatment. The Congressional letter goes on to ask the administration to “ensure that hospitals are appropriately reimbursed so they may continue to provide” CAR-T therapy to America’s seniors...without appropriate reimbursement policy, a Medicare patient could be denied access to a treatment that would save his or her life. Without proper reimbursement by Medicare, providers simply will not be able to offer it as an option, especially in rural areas as patients must stay near a treatment center for four weeks to be monitored...READ MORE

While eyes have been on China for signs that COVID-19 might result in drug shortages, India has come up with a surprise of its own. The country, which accounts for about 40% of U.S. generic drugs, has halted exports of more than two dozen APIs and drugs...India’s Directorate General of Foreign Trade today announced it was restricting 26 APIs and formulations until further notice...The government gave no further explanation, but Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India, told Reuters, “Irrespective of the ban, some of these molecules may face shortages for the next couple of months.” If interruptions from the virus get worse, he said, some shortages may become “acute.”...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