Pharmaceutical giant Merck & Co has taken legal action against the U.S. government in an attempt to halt the drug price negotiation program outlined in the Inflation Reduction Act (IRA), Your Content has learned.
The company argues that this program infringes upon the Fifth and First Amendments of the U.S. Constitution.
This lawsuit marks the first instance of a drugmaker challenging the new law, which the pharmaceutical industry believes will lead to decreased profits and hinder the development of groundbreaking treatments.
The Biden administration’s drug pricing reform initiative aims to achieve annual savings of $25 billion by 2031 through negotiations on Medicare drug prices.
Merck’s lawsuit, filed in the U.S. District Court for the District of Columbia, contends that the law would compel drug manufacturers to negotiate drug prices for the government’s Medicare health insurance program at rates below the market value.
The company claims that this violates the Fifth Amendment, which requires the government to provide just compensation for private property taken for public use.
Drug industry lobbyists and lawyers had previously indicated that legal challenges would be made against the government’s pricing reforms, alleging noncompliance with the U.S. Constitution, after the government released its roadmap for negotiations in March.
According to Merck, the Inflation Reduction Act utilizes harsh penalties to obtain medicines without fair compensation, coercing manufacturers into accepting the situation as a “fair” and voluntary exchange. The company describes this as a form of political theater.
Merck further argues that the law will compel companies to enter agreements declaring that the negotiated prices are fair, violating the protections of free speech enshrined in the First Amendment.
The lawsuit was filed against the U.S. Department of Health & Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS), as well as HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure. HHS and CMS have not provided immediate comments on the matter.
Merck has expressed its intention to pursue litigation up to the Supreme Court, if necessary.
The inaugural process for reducing Medicare drug prices is scheduled to commence in September when CMS identifies the ten most expensive drugs.
After negotiations on these drugs, the new prices will take effect in 2026, potentially reducing industry sales by $4.8 billion in the first year alone, according to U.S. News.
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