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California could make its own insulin and other prescription drugs in an effort to lower costs under a bill Gov. Gavin Newsom announced he signed into law Monday. Newsom first proposed that California create its own prescription drug label in his January budget proposal. The legislation Newsom signed, Senate Bill 852, attempts to implement that plan by directing California’s Health and Human Services Agency to explore partnerships with drug manufacturers that could make drugs more affordable and accessible. (Bollag, 9/28)

In a groundbreaking move, California adopted a law Monday to allow the state to develop its own line of generic drugs, a notion designed to address the rising cost of prescription medicines that is straining many government budgets across the U.S. Specifically, the California Health and Human Services Agency will look to form partnerships to manufacture or distribute generics and at least one form of insulin. (Silverman, 9/28)

A mandated safety program regulators rely on to minimize opioid abuse and misuse is not “well suited” to quickly address the ongoing crisis across the U.S. And the shortcomings reflect a lack of cooperation from opioid makers that made it difficult for the Food and Drug Administration to assess key data, according to a new federal government report. (Silverman, 9/29)

The House Oversight Committee will hold two days of hearings this week with six drug industry CEOs. The hearings are the presumptive climax of an 18-month investigation first launched by the late Rep. Elijah Cummings in 2019. The hearing could be the most perilous yet for drug makers, who have managed to avoid any major missteps at the multiple congressional drug pricing hearings that preceded this one. (Florko, 9/29)

Japanese drug maker Shionogi, with US headquarters in Florham Park, New Jersey, announced today that the Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application for cefiderocol. The FDA's approval means that cefiderocol, sold under the brand name Fetroja, can be used to treat patients who have hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by gram-negative pathogens. The antibiotic was initially approved for treatment of complicated urinary tract infections. (9/28)