EpiPen epinephrine auto-injectors made by a U.S. pharmaceutical company.
President Joe Biden‘s Department of health (HHS) on Monday (Jan. 25) froze the Trump administration’s drug rule that mandates hospitals and community health centers to lower the price of insulin and epinephrine boosters to ensure Americans get prescription drugs at the cheapest possible prices.
According to a Federal Register notice, the new administration’s action temporarily delays the effective date of the final rule implementing the Executive Order on Access to Affordable, Life-Saving Drugs, published in December 2020, by 60 days. The Department of Health said, “The temporary delay in the effective date of this final rule is a necessary move that will give Department officials an opportunity to further review and consider the new regulations and align (the newly effective drug provisions) with the January 20, 2021 (Biden-signed) memorandum.”
White House Chief of Staff Ron Klain said the move is one of the current administration’s actions to review the former president’s its health policies and other executive orders. According to the directive issued by Klain, the drug regulation will be delayed for 60 days to take effect while the new administration conducts its review.
On July 24, 2020, Trump signed four executive orders aimed at lowering drug prices, which are (1) significantly reducing the price of insulin and epinephrine. (2) Allow states, pharmacies and wholesalers to safely and legally import prescription drugs from countries such as Canada. (3) Return to patients the rebates that middlemen receive from pharmaceutical companies. (4) Set the price of prescription drugs paid to providers by the federal health care program (Medicare) based on the lowest prices of the same prescription drugs in other developed countries.
Among other things, the insulin and epinephrine rules were scheduled to take effect on Jan. 22, 2021.
Kline said, “With respect to rules that have been published in the Federal Register, or that have been published in any way but have not yet taken effect, (consideration will be) given to delaying the effective date of the rules by 60 days from the date of this memorandum, consistent with applicable law.”
Klein explained that “for rules that are postponed in this manner, a 30-day comment period will be considered open during the 60-day period, where appropriate and consistent with applicable law, to allow interested parties to submit comments on factual, legal, and policy issues regarding those rules and to consider pending petitions for review involving such rules.”
According to the Bloomberg Law article, critics of the regulations say that hospitals and medical centers that provide both drugs “already pass on the savings (on the drugs) to their (patients), and the rule is simply an administrative burden that portrays them (hospitals and medical centers) as entities that price gouge patients.”
Trump also signed an executive order last September to lower the price of drug prescriptions.
In his Sept. 13, 2020 order, he wrote: “It is unacceptable that Americans are paying more for the exact same drugs, often manufactured in the same place.” The order required the then-Secretary of Health to “take immediate and appropriate steps to implement his rulemaking plan to test payment models” and to implement a “most favored nation” policy.
Trump tweeted afterward, “My MFN order will ensure that our country gets the low prices that Big Pharma offers to other countries.”
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