Author: Peter

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

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

The FDA issued a final rule amending the definition of “biological product” to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market...The final rule clears the way for the agency’s March 23 transition of filings for chemically synthesized polypeptides, including insulin products, from new drug applications to biologics license applications...The FDA anticipates that the change will add more choices for patients and potentially reduce insulin prices. The final rule “will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition,” said FDA Commissioner Stephen Hahn.

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

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

In new comments to the US government, several pharmacy groups say that mergers of major companies, such as CVS Health and Aetna, have had significant anticompetitive effects without improving the cost and quality of health care...The Alliance for Pharmacy Compounding, American Pharmacists Association, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, and National Community Pharmacists Association collectively urged for antitrust policy reform in a joint comment to the Federal Trade Commission and the Department of Justice Antitrust Division...READ MORE

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

Gov. Steve Sisolak...delivered a message of unity and calm Friday afternoon as Nevada prepares for possible coronavirus cases...There have been no confirmed cases of coronavirus...in Nevada, Sisolak said, before urging residents to continue practicing basic hygiene methods, such as washing hands with soap and water, coughing into your elbow and staying home from work or school if sick...“We’re going to prepare, not panic,” he said at a press conference in Las Vegas. “We’re going to choose collaboration over chaos.”...READ MORE

COVID-19's global spread has raised fears over drug shortages and price spikes, but Novartis' Sandoz is taking an early step to allay those concerns. The drugmaker, a top player in generics and off-patent antibiotics, pledged “stable” pricing for certain essential drugs and antibiotics amid the crisis...No matter how the supply chain situation plays out, Sandoz pledged to “keep prices stable for certain essential medicines it markets commercially," CEO Richard Saynor said in a statement...The commitment comes amid fears that the global supply chain will face disruption from an outbreak that’s so far taken its biggest toll in China, a manufacturing powerhouse where many of the pharmaceutical industry's starting materials are made...READ MORE

A Florida law restricting the quantity of opioids a doctor can prescribe for acute pain to three days’ worth may have led to overall reductions in opioids dispensed to patients in the state,..After the law was passed in July 2018, doctors wrote fewer and shorter prescriptions for opioids...“The policy was intended to reduce the quantity prescribed but it was not expected to decrease opioid use overall,” said study coauthor Dr. Juan Hincapie-Castillo of the University of Florida College of Pharmacy...“But fewer people were getting opioids. That means the law led not only to a reduction in the quantity dispensed, but also to a reduction in the initial decision to prescribe.”...READ MORE