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June 30 (Reuters) - The U.S. government on Friday revised its guidance for its Medicare drug price negotiation process, allowing drug companies to publicly discuss the talks, but did not make major changes likely to convince drugmakers to end their suits seeking to halt the program. In September, the U.S. Centers for Medicare and Medicaid Services (CMS) will select 10 of the Medicare program's costliest prescription medicines and negotiate price cuts to go into effect for 2026. That guidance precluded drug makers from talking about the negotiations and required them to eventually destroy data received from CMS. Industry group the Pharmaceutical Research and Manufacturers of America (PhRMA) made an additional claim that the price negotiation program violates the U.S. Constitution's Eight Amendment, which protects against excessive fines. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for the drugs most costly to Medicare.
Persons: drugmakers, Joe Biden, Chiquita Brooks, LaSure, Bristol Myers, Merck, PhRMA, Tahir Amin, Amin, Michael Erman, Mark Potter, Nick Zieminski Organizations: U.S, U.S . Centers, Medicare, Medicaid Services, Merck & Co, Bristol Myers Squibb, U.S . Chamber of Commerce, CMS, Merck, Bristol, Industry, Pharmaceutical Research, Manufacturers of America, Reuters, Initiative for Medicines, Biden, Thomson Locations: U.S
If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. "The clock for that patent would start ticking from the time we would get that patent approved." Drug patents have a guaranteed term of exclusivity for 20 years after receiving a patent under U.S. law, but sometimes the companies are able to add additional patents that extend their exclusivity. Merck's patents on the subcutaneous version of Keytruda could protect that formulation until at least 2040, according to Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Access & Knowledge (I-MAK). Northwell's Mulloy said moving patients to subcutaneous versions of drugs also opens up spots in infusion centers for additional patients.
The Inflation Reduction Act is set to lower drug prices for millions of people in the United States — but experts fear pharmaceutical companies could exploit loopholes in the bill, ultimately keeping prescription costs high for many. The tactics may ultimately threaten the law’s ability to lower drug costs for consumers. Higher prices for new drugsOther experts are concerned about how companies might abuse the inflation rebate rule in the health law. The provision, which takes effect next year, imposes a rebate on drug manufacturers that raise the prices of their medications faster than inflation. By releasing new drugs at higher prices, drug companies will be able to make up for any lost revenue that they would normally receive from steadily raising prices each year, she said.
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