FDA gearing up for insulin biosimilars

MAY 13: The intricacies of drug-pricing policy will be on display at a Food and Drug Administration public hearing on insulin biosimilars. What’s the big deal? Starting in March 2020, insulin will be classified as a biologic, a positive for patients. “There are currently no approved prescription insulin products that can be substituted at the pharmacy level,” the agency said in its meeting notice, adding, “An interchangeable insulin product can be substituted for the reference insulin product at the pharmacy, potentially leading to increased access and lower costs for patients.” The FDA said it wants to hear from patients, providers and manufacturers about the “development process” for biosimilars.

MAY 15: The House Ways and Means Committee will tackle the hot topic (pun intended) of the “economic and health consequences of climate change.” The World Health Organization called climate change the “greatest challenge of the 21st Century.” The Medical Society Consortium on Climate Change and Health, a group of 23 medical societies, has called on policymakers to pay more attention to the health implications of climate change. In related news, Alex Kacik reports on p. 10 about the wide variation that exists nationwide in emergency preparedness, including for environmental disasters.

MAY 15: The Veterans Affairs Department is heading into the home stretch of launching the new Veterans Community Care program. Mandated by the Mission Act, the program consolidates seven existing programs that pay for veterans’ care outside the VA system into one. As Harris Meyer reported in our April 29 issue, there are significant concerns about the department’s readiness to deploy the program. Members of the House Veterans’ Affairs health subcommittee will get their chance to question officials about this and other topics during a hearing on the Veterans Health Administration’s fiscal 2020 budget.