- Cardinal Health pays SEC $8.8 million to settle China FCPA offenses (fcpablog.com)
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
- FDA Issues Final Rule Expanding Availability of Insulin Products (fdanews.com)FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products (fda.gov)
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.
- Coronavirus live updates: FDA reports 1st drug shortage due to novel coronavirus outbreak (abcnews.go.com)Drugmakers tell analyst ingredient prices are rising as FDA reports first supply hit tied to COVID-19 (fiercepharma.com)
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
- Coronavirus spreads faster outside China as fears of U.S. impact hit markets (reuters.com)Tracking China’s novel coronavirus (graphics.reuters.com)
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
- Pharmacy Groups Express Concerns About Health Care Megamergers (drugtopics.com)
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
- This Week in Managed Care: February 28, 2020 (ajmc.com)
Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network
- February 27: Pharmacy Week in Review (pharmacytimes.com)
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.
- Sandoz pledges ‘stable’ pricing for generics, antibiotics amid COVID-19 supply chain worries (fiercepharma.com)
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
- Florida law limiting first opioid prescription linked to drop in use (reuters.com)Changes in Opioid Use After Florida’s Restriction Law for Acute Pain Prescriptions (jamanetwork.com)
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
- Pharmacists Concerned About Shortages in Wake of Coronavirus (drugtopics.com)Hawley Introduces Bill to Reduce Reliance on Chinese Medical Supply Chain (nationalreview.com)
Although drug shortages due to the novel coronavirus disease outbreak haven’t occurred yet, the FDA and pharmacists are closely watching for potential shortages. Separately, pharmacists should urge Americans to get flu vaccinations and take a cautious approach with coronavirus…“While our primary concern is the health and safety of those affected by the virus, ASHP is concerned with the vulnerability of the pharmaceutical supply chain to threats like the coronavirus outbreak,” Michael Ganio, PharmD, BCPS, director of pharmacy practice and quality at ASHP...An estimated 80% of active pharmaceutical ingredient used in the US market comes from foreign sources. In addition, the FDA has recalled inspectors from China due to the outbreak, which could possibly lead to delays in manufacturing...READ MORE