A coalition of state attorneys general on June 10 filed the third in a series of lawsuits in U.S. federal court citing widespread price-fixing in the generic drug industry. The latest suit names 10 individual executives and 26 manufacturers of generic dermatological drugs, alleging “broad, coordinated and systematic antitrust violations, price-fixing, market allocating and the rigging of bids for more than 80 different topical generic drugs,” according to the New York Attorney General’s Office. From at least 2007 through 2014, three manufacturers – Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., Perrigo Co. plc, of Dublin, and Fougera (now Sandoz Inc., part of Basel, Switzerland-based Novartis AG) – sold about two-thirds of all the generic topical products dispensed in the U.S. In an effort to manipulate the market, “these companies repeatedly communicated directly and specifically to minimize competition, including by substantially raising prices on dozens of topical products,” according to the complaint. It added that the other generic manufacturers – including Mylan NV, of Hertfordshire, U.K., Jerusalem-based Teva Pharmaceutical Industries Ltd. and Mumbai-based Glenmark Pharmaceuticals Ltd. – did the same.
Charles Lieber, the former chair of Harvard University’s Chemistry and Chemical Biology Department, was indicted June 9 on two counts of making false statements to federal authorities regarding his participation in China’s Thousand Talents Program. Lieber, who was arrested on Jan. 28, is alleged to have become a “strategic scientist” at Wuhan University of Technology (WUT) in China, beginning in 2011, and later becoming a contractual participant in the Thousand Talents Program, a talent recruitment plan designed to attract, recruit and cultivate high-level scientific talent. Under the terms of Lieber’s three-year Thousand Talents contract, WUT allegedly paid him a salary of up to $50,000 per month, living expenses of up to ¥1 million (about US$158,000 at the time) and awarded him more than $1.5 million to establish a research lab at WUT. It is alleged that Lieber lied to federal authorities about his involvement in the Thousand Talents Plan and his affiliation with WUT. According to charging documents, since 2008, Lieber has served as principal investigator of the Lieber Research Group at Harvard University, specializing in the area of nanoscience. His research at the Lieber Research Group has been funded by more than $15 million in research grants from the NIH and Department of Defense. Among other things, those grants required the disclosure of all sources of research support, potential financial conflicts of interest and all foreign collaboration.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its business plan for 2020-21, with a focus on a post-Brexit strategy that outlines how it intends to operate going forward. The agency disclosed its “change strategy” and listed three fundamental shifts. The first focuses on U.K. patient access, calling for access to innovative products, with oversight and clinical impact from earliest use. The second involves transformed postmarket surveillance aiming for a systemic data-driven analysis of real-world use in the National Health Service, underpinned by data analytics and increased AI capacity. The third focuses on impact, with plans to engage patients in the MHRA’s work to influence on clinical practice and enable patients to make informed decisions. Among the agency’s priorities for 2020-21 is to become more patient-centered; be ready with new routes to market for medicines and medical devices by Jan. 1, 2021, when the post-Brexit transition period ends; and work with the National Institute for Biological Standards and Control to play a part in the national public health challenged caused by COVID-19.
The FDA and National Center for Advancing Translational Sciences (NCATS) at the NIH said they made updates to the CURE ID application to be a more effective tool during the COVID-19 public health emergency. CURE ID is an internet-based repository that allows clinicians to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing drugs through a website, a smartphone or other mobile device. Clinicians can also access cases entered by other users and view them as individual case reports or an aggregated dataset. The FDA and NCATS/NIH are also collaborating with the National Institute of Allergy and Infectious Diseases at NIH, the CDC, the Critical Path Institute, the World Health Organization and the Infectious Diseases Society of America to assess the global utility of the CURE ID platform for COVID-19 case information.