ALPMF - Big pharma maps legal strategy against U.S. drug pricing regulation - Reuters
2023-05-09 08:56:49 ET
Leading drugmakers are prepping for a legal fight against recently implemented U.S. drug pricing reforms which bring negotiating power to Medicare for the first time ever, Reuters reported Tuesday, citing industry sources.
In March, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Medicare drug price negotiation program that will go into effect in 2026 as part of the Biden Administration's Inflation Reduction Act (IRA) which became law last year.
Accordingly, CMS will first identify the top 50 costliest drugs to Medicare and, by September, finalize a list of the top 10 candidates for negotiations.
However, arguing that the agency does not comply with either Biden's legislation or the U.S. Constitution, drugmakers are threatening to file lawsuits unless Medicare changes its proposals before finalizing them, three industry lobbyists and lawyers said.
Blood thinner Eliquis, marketed by Bristol Myers ( NYSE: BMY ) and Pfizer's ( NYSE: PFE ), breast cancer therapy Ibrance from Pfizer ( PFE ), the blood cancer therapy Imbruvica marketed by AbbVie ( NYSE: ABBV ) and Johnson & Johnson ( NYSE: JNJ ) are said to be prime candidates for negotiations.
Novo Nordisk's ( NVO ) diabetes therapy Ozempic, Astellas Pharma's ( OTCPK:ALPMF ) ( OTCPK:ALPMY ) prostate cancer treatment Xtandi, and Xarelto, an anticoagulant marketed by Pfizer ( PFE ) and J&J ( JNJ ) are also at risk of negotiations, according to industry observers.
"I would be shocked if there wasn't litigation," Reuters reported quoting a head of government affairs at a leading drugmaker, who was not permitted to comment on the matter.
According to one lawyer who serves multiple pharmaceutical companies, drugmakers could file for emergency injunctions to delay government negotiations.
More on U.S. drug pricing reforms
- Bipartisan prescription drug price legislation hits snag - Bloomberg
- Democratic senators introduce bill to enhance CMS drug price negotiations
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Big pharma maps legal strategy against U.S. drug pricing regulation – Reuters