The Canadian government approved Interim Order (IO) No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Intended to alleviate shortages, the approval extends for one more year the pandemic measures allowing the import of drugs and devices that may not fully meet Health Canada’s regulatory requirements but that are manufactured to comparable standards. It also continues the requirement from a previous IO that expires next week for certain manufacturers and importers of medical devices to notify the Minister of Health of shortages. A new provision in the order gives importers six months to make the information for the safe use of a drug or device available in both French and English. As of Feb. 17, 56 drugs and 265 medical devices were permitted for exceptional importation and sale under IO No. 1. As evidence of the need for the import program to continue after the March 30 expiration of that order, a government notice in the March 20 Canada Gazette said that since March 2020, Health Canada has responded to 45 Tier 3, the highest impact, drug shortages, compared with 10 Tier 3 shortages in 2019. And of more than 400 medical device shortage reports received as of Feb. 17, 281 were confirmed and posted. Before the first IO required manufacturers to report shortages of pandemic-related devices, Health Canada was notified of only 27 device shortages from 2015 to February 2020. “While the supply and demand levels for some health products are stabilizing, the need for vigilance continues,” according to the notice.
MHRA resumes some onsite inspections
After an 82-day pause on all onsite inspections, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) plans to resume its onsite U.K. risk-based GxP quality inspections March 29. The agency suspended all inspections Jan. 5 due to social distancing requirements and pandemic travel restrictions. Although the risk-based inspections will resume, it won’t be business as usual, according to a March 19 guidance. The MHRA said it will continue to use a combination of remote and onsite approaches in an effort to reduce the regulatory burden during the pandemic. The agency also plans to give at least 14 days’ advance notice, when possible, to enable COVID-19 risk mitigation planning ahead of an inspection. When short notice or unannounced inspections are necessary, MHRA inspectors will discuss COVID-19 risk mitigation measures with the organization on arrival.
Kyprolis discount opens door to U.K. coverage
Amgen Inc.’s confidential discount paved the way for the U.K.’s National Institute for Health and Care Excellence (NICE) to recommend a triple therapy including Amgen’s Kyprolis (carfilzomib) as a second-line treatment for multiple myeloma. Clinical trial evidence shows that using carfilzomib with lenalidomide ad dexamethasone provides longer periods of remission and survival than the current second-line treatment of just lenalidomide ad dexamethasone, according to NICE’s final draft guidance, which is expected to be published next month. The benefit of the triple therapy appears to continue for up to six years, but NICE said how long it extends beyond that is uncertain. U.K. patients will be offered a maximum of 18 cycles of the treatment in accordance with the guidance.
HHS delays Trump ‘Sunset’ rule
Citing a lawsuit filed earlier this month, the U.S. Department of Health and Human Services (HHS) and its agencies are delaying the implementation of yet another last-minute rule from the Trump administration. The “Sunset” rule, published Jan. 19 and originally scheduled to take effect March 21, was basically a housecleaning rule that required HHS and individual agencies to regularly evaluate existing regulations to ensure they were effective and still necessary. Under the rule, all regulations, with certain exceptions, would expire five years after the year the Sunset rule becomes effective, 10 years after the year the regulation was promulgated or 10 years after the last year in which HHS assessed the regulation – whichever is latest. In a notice to be posted in the March 23 Federal Register, HHS said it will delay implementation of the rule until March 22, 2022, so the court can consider the challenge and to give the department time to review the rule in light of the claims raised in the litigation.