The law, which empowers the U.S. government to negotiate prices with drugmakers on the most expensive prescription drugs as soon as nine years after they hit the market, will slow access to life-saving treatments for patients, Soriot said in an interview broadcast by Reuters.
“Companies will delay the longshot new product in late line indications,” Soriot said, referring to the process whereby promising medications win initial approvals to benefit patients with late-stage disease—before enough data are available to support broader use.
“That’s unfortunate because patients will suffer, but companies will have no choice because you have to protect your ability to invest in future R&D,” he added.
Pharma companies have been critical of the legislation, which aims to make drugs more affordable, on the grounds that it will stifle innovation and harm patients. Soriot said he hopes the rules can be modified, as “it will create a few reactions or behaviors that are not healthy for anybody.”
Beginning in 2026, the 10 most expensive prescription drugs dispensed at the pharmacy counter without a generic substitute that have been on the market for nine or 13 years, depending on drug type, would be subject to price negotiation.
Should companies refuse, they would face a tax of 65% to 95% on the sales they made the previous year. By 2029, Medicare, the government insurance program for seniors, could increase to 20 the number of drugs subject to the rules, including those administered by doctors.
Soriot warned that drugmakers would very likely respond to the changes by waiting until more data accrued from clinical trials to support use in a substantial patient pool before seeking approval, rather than the current practice of rushing drugs to market as a late-line treatment.
Drugmakers need to ensure they can recoup their investment by maximizing revenue from the widest possible patient population before the mandatory price negotiation kicks in, Soriot said.