USA — The US Chamber of Commerce has taken legal action against the Department of Health and Human Services (HHS) in a lawsuit filed late Friday.
This follows a similar lawsuit filed by Merck earlier in the week, both contesting the implementation of drug price negotiations under the Inflation Reduction Act (IRA).
Merck’s lawsuit specifically argues that the IRA infringes upon the First and Fifth Amendments.
The Chamber of Commerce raises concerns about the compelled-speech provisions of the IRA and highlights potential violations of the First Amendment.
The lawsuit, filed in the Southern District of Ohio, asserts that the negotiation process leading to lower drug prices is a facade as it ultimately results in government-imposed price controls.
The Chamber argues that such a system contradicts fundamental principles of separation of powers, nondelegation, and due process of law.
They also claim that it imposes excessive fines and compels speech, both of which are in violation of the First Amendment.
One of the key issues raised by the Chamber is the broad discretion granted to the HHS Secretary in setting prices for the most expensive drugs.
The lawsuit points out that while the IRA allows the Secretary to demand confidential information from manufacturers, it lacks clear standards governing the use of that information in price setting.
Furthermore, the chamber questions a provision in the IRA that mandates manufacturers to remove all their drugs from Medicare and Medicaid if they refuse price controls on one drug.
The lawsuit asserts that such a requirement would have dire consequences for millions of beneficiaries and would be economically infeasible.
HHS is scheduled to select the first 10 drugs for negotiations in September, and Merck anticipates that its diabetes drug Januvia, which generated US$4.5 billion in sales last year, will be included.
Other pharmaceutical companies, such as Eli Lilly, AstraZeneca, AbbVie, J&J, and Novartis with its breast cancer drug Kisqali, may also have drugs targeted for CMS negotiations in the future.
The Chamber of Commerce emphasizes the wider implications of the IRA, suggesting that it is designed to shield the government from accountability and pave the way for centralized planning and socialized medicine.
They argue that the consequences of these actions will be significant for the American people.
The timing of these lawsuits is crucial, as starting from October 2, drug manufacturers in the top 10 list (published on September 1) will be required to enter into agreements with CMS, providing confidential information on various aspects, including R&D costs, recouped costs, federal financial support, and revenue and sales data.
These legal challenges pose significant implications for the implementation of drug price negotiations under the IRA and may shape the future of pharmaceutical pricing in the United States.
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