A group of Republican lawmakers are raising concerns over the Biden Administration’s initial drug price-setting program implementation guidance document.
The lawmakers – U.S. Sen. Mike Crapo (R-ID) and U.S. Reps. Jason Smith (R-MO), and Cathy McMorris Rodgers (R-WA) – contend that the guidance will deter product improvements for existing drugs, discourage public-private partnerships, weaken intellectual property protections and fail to provide stakeholders with adequate transparency.
“We write to express disappointment and concern with recent implementation guidance for the drug price-setting provisions included in the Inflation Reduction Act. This guidance exacerbates the law’s statutory flaws and compounds the profound uncertainty and risk posed by the legislation’s sweeping drug price controls,” the lawmakers wrote to U.S. Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure.
The guidance lays out how the federal government would negotiate drug prices with manufacturers for Medicare Part D for a select number of drugs, starting with 10 for which there are no generic alternatives. The negotiated prices would become effective in 2026, after negotiations end in 2024. Also, there is a rebate program where select drug manufacturers will pay rebates to Medicare if their prices rise faster than inflation.
“The Administration’s guidance clearly values government power and overreach above precedent and statute, at the expense of patients seeking potentially life-saving treatments,” the letter continued. “We urge you to work diligently and quickly to address these and other issues as you begin implementing this far-reaching new price control program. The preliminary decisions made through this initial guidance process, if carried out without greater reflection and input from the public, will have dire consequences for American patients for decades to come.
Crapo is the ranking member of the Senate Finance Committee, Smith is the chair of the House Ways and Means Committee, and McMorris Rodgers is the chair of the House Energy and Commerce Committee.