The U.S. Department of Health and Human Services (HHS) is appealing a federal judge's decision that struck down a rule requiring TV ads for certain prescription drugs to include the list price of the drug. HHS filed its appeal Wednesday in the U.S. Court of Appeals for the District of Columbia Circuit. The rule was tossed last month, just hours before it was to go into effect. In the decision, Judge Amit Mehta showed some sympathy for the intent behind the rule but said HHS' Centers for Medicare & Medicaid Services didn't have the authority to regulate TV ads – or, for that matter, the pharmaceutical market. (See BioWorld, July 10, 2019.)
Concerned about the number of drug shortages plaguing U.S. hospitals and impacting patient care, Sen. Gary Peters (D-Mich.), the ranking member of the Senate Committee on Homeland Security and Governmental Affairs, is investigating what's behind those shortages and whether the FDA has the authority it needs to adequately mitigate them. In a letter Wednesday to Acting FDA Commissioner Ned Sharpless, Peters cited figures from the American Society of Health-System Pharmacists (ASHP) showing that new and active drug shortages in the U.S. are at their highest level in nearly five years. According to ASHP, 80 new shortages were reported in the first half of this year, compared with 186 reported last year. However, since many shortages from previous years had yet to be resolved, the number of active shortages hit 282 last quarter. That's the highest number of active shortages since the fourth quarter of 2014, which had 301 ongoing shortages. The FDA has been working to resolve the shortages, which range from generic antibiotics to nuclear medicine to drugs as basic as sodium chloride. As of Thursday, the agency was reporting 116 current drug shortages. Peters linked the problem to higher health care costs due to poorer patient outcomes and the time providers spend dealing with the shortages. "Nationally, hospitals spend over $359 million annually on labor costs alone to manage the impacts of drug shortages," Peters said.
After two decades of helming the U.K.'s National Institute for Health and Care Excellence (NICE), Andrew Dillon said Thursday that he will be stepping down as chief executive at the end of March. Dillon is the only chief NICE has known, as he has been leading the institute since its founding in April 1999. NICE said its board will make arrangements to advertise for the chief executive's post within a few months.
The Institute for Clinical and Economic Review (ICER) is proposing changes to its methods for conducting value assessments of therapies beginning in 2020. The proposals include augmenting ICER's efforts to use real-world evidence, creating a new process for reevaluating evidence a year after each final evidence report is issued, addressing alternative modeling assumptions, expanding its evidence-rating categories to more effectively distinguish between situations that may share a high certainty of at least a comparative net health benefit but have the potential for widely different best-case scenarios, and providing a crosswalk between its evidence ratings and those of the German health technology assessment system. ICER also proposed standardizing its cost-effectiveness thresholds from $50,000 to $200,000 per quality-adjusted life year (QALY) and per the equal value of life years gained (evLYG), including those for treatments of ultra-rare disorders. However, the value-based price benchmarks would continue to use the threshold ranges of $100,000 to $150,000 per QALY and per evLYG, ICER said. The independent nonprofit will hold a public webinar on the proposal Sept. 4 and plans to release its final 2020 value assessment framework Dec. 18.
The Therapeutics Goods Administration (TGA) Thursday announced several steps it's taking to tackle the growing abuse and misuse of prescription opioid drugs in Australia. In addition to making smaller pack sizes available for immediate-release prescription opioids, the TGA is requiring sponsors to include boxed warnings and class statements on their labeling, indicating an opioid product's potential for harmful and hazardous use. The agency said it will work with sponsors to ensure that safety information is prominently and consistently displayed in the consumers medicines information, and that the labeled indications reinforce that opioids should only be used when other analgesics have proven ineffective. Given the increased potential for the harmful and hazardous use of fentanyl, the TGA will require the indication for fentanyl patches to be updated to state they should only be prescribed to treat pain in patients with cancer, in palliative care or with exceptional circumstances.
As part of the international response to the Ebola virus outbreak in the Democratic Republic of the Congo (DRC) and to meet U.S. domestic biodefense goals, HHS' Biomedical Advanced Research and Development Authority (BARDA) will provide an additional $23 million to Merck & Co. Inc., of Kenilworth, N.J., to support the manufacturing of V920, an investigational Ebola vaccine, over the next year. That funding will bring BARDA's total support for development of the vaccine to about $176 million. In addition, the U.S. Department of Defense and the NIH have supported numerous pre-clinical and clinical research projects related to the vaccine. As of last week, more than 192,000 people at risk of contracting Ebola in the DRC had been vaccinated with V920 through compassionate use. BARDA said it will continue to work with Merck on advancing the vaccine toward FDA licensure. It also is collaborating with federal and private partners to develop Ebola diagnostics and treatments.
Canadian Minister of Health Ginette Petitpas Taylor Thursday announced a five-year, $1.4 million government investment in a new national network to fill in the research gaps about the causes of, and treatments for, myalgic encephalomyelitis (ME), formerly known as chronic fatigue syndrome. To be headquartered at the Sainte-Justine University Hospital Research Centre in Montreal, the network of researchers, clinicians and patients will be led by Alain Moreau, a professor at the University of Montreal. The funding will be used to investigate ME's possible links to viruses and genes, link patient and researcher cohorts in Canada with those in the U.S., and support Canada's graduate students working on ME.