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Tuesday, 06/06/2023 12:03:34 PM

Tuesday, June 06, 2023 12:03:34 PM

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MRK sues US over IRA drug-price “negotiation”:

https://www.wsj.com/articles/merck-challenges-u-s-governments-new-powers-to-negotiate-drug-prices-127d4b0c

Drugmaker Merck & Co. filed a lawsuit on Tuesday challenging the U.S. government’s plan to negotiate drug prices, saying it is unconstitutional.

Drugmakers were expected to file lawsuits challenging the program, especially as Medicare neared the date later this year when it began naming some drugs it would target for price negotiations.

Among the drugs that analysts expected to face price negotiations are Merck’s top-selling product, the cancer immunotherapy Keytruda.

Merck’s complaint takes issue with the negotiation program’s enforcement rules, which include the power to levy an excise tax of up to 95% of a drug’s U.S. sales if a pharmaceutical company refuses to sell the drug to Medicare patients. Merck said the tax would be coercive and violate the constitution’s Fifth Amendment ban on private property being taken for public use without just compensation. [The so-called “takings” clause.]

Merck also said the law would force companies to agree that the government-mandated prices are “fair,” violating its free speech rights under the First Amendment.

For biotech investors, there’s a lot riding on the outcome of this lawsuit and related cases.

Want more details? See https://www.cms.gov/files/document/medicare-drug-price-negotiation-program-initial-guidance.pdf (91 pages).

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