In his first days in office, President Joe Biden went on a blitz of reversing or halting policies implemented by former President Donald Trump. Included in the flurry of executive orders and directives, the Biden administration paused a measure that was designed to decrease the price of insulin.
Trump signed off on the "Access to Affordable Life-Saving Medications" rule on Dec. 23, 2020. The rule was to enable "improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements."
The rule was set to go into effect on Jan. 22, 2021, but it was shot down by the Biden administration. On Wednesday, the Department of Health and Human Services announced that the directive would be frozen for 60 days.
"The temporary delay in the effective date of this final rule is necessary to give Department officials the opportunity for further review and consideration of new regulations, consistent with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled 'Regulatory Freeze Pending Review,'" the HHS said.
White House chief of staff Ron Klain sent out a memo on Wednesday that directed agencies to freeze all of Trump's last-minute or "midnight regulations." The action to freeze Trump's last regulations will "give the incoming Administration an opportunity to review any regulations that the Trump Administration tried to finalize in its last days," according to the Biden administration.
The directive that orders certain health centers to pass discounts they get on insulin and epinephrine directly to their patients will be frozen until March 22.
As of 2020, "34.2 million Americans — just over 1 in 10 — have diabetes, and another 88 million American adults—approximately 1 in 3—have prediabetes," according to the Centers for Disease Control and Prevention.
"In 2016, the U.S. Centers for Medicare & Medicaid Services (CMS) estimated that Medicare spent $42 billion more for beneficiaries over age 65 with type 2 diabetes than for those who do not have the disease," the CDC stated.
The Kaiser Family Foundation, a nonprofit organization focusing on national health issues, reported that the "average total Medicare Part D spending per user on insulin products increased by 358% between 2007 and 2016, from $862 to $3,949."
As far as insulin sales in the United States, there are the "big three" pharmaceutical giants: Eli Lilly and Company, Sanofi, and Novo Nordisk.
A report from the offices of Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), leaders of the Senate Finance Committee, investigated the soaring insulin prices, and found a "broken" system to blame.
"This investigation makes clear that consumers are the only ones losing out in America's broken drug pricing system, since every part of the pharmaceutical supply chain benefits from higher list prices," Wyden said in a statement.
Novo Nordisk and Sanofi reportedly engaged in a "cat-and-mouse strategy of pricing," where the pharmaceutical companies would match or increase prices any time the competitor raised its prices.