Pharmalittle: Pharma likely to expand legal attacks on Medicare negotiations; CDC recommends rationing RSV drug

By Ed Silverman Oct. 25, 2023

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Alex Hogan/STAT

Good morning, everyone, and how are you today? We are doing just fine, thank you. After all, the birds are still chirping and a cool breeze is wafting by the placid Pharmalot campus. Moreover, this marks the middle of the week, which means we have managed to survive this far. And this calls for celebration, yes? So please join us as we hoist another cup of delicious stimulation. Remember, no prescription is required, so there is no need to negotiate rebates. Our choice today is mocha marshmallow. Meanwhile, here are a few items of interest. Have a grand day, and drop us a line if you hear something juicy. …

Major drug companies are likely to ratchet up a sprawling legal attack aimed at challenging the Medicare drug-price negotiation process, Bloomberg Law reports. “There is likely to be a second wave” of lawsuits, said Stephen Ubl, who heads the Pharmaceutical Research & Manufacturers of America trade group. Nine lawsuits have been filed and, so far, the focus has largely been on arguments that negotiations are unconstitutional, alleging they violate the First, Fifth, and Eighth amendments of the U.S. Constitution. Ubl said future attacks are likely to be “applied challenges,” and over time, to target “the application” of the law, such as fines or other parts of the negotiation process.

The European Commission launched some short-term measures to prevent medicine shortages this winter and the next as a stop-gap while a proposed pharmaceutical rules overhaul is hashed out by the European Union’s key legislative arms, Reuters reports. After the Covid-19 pandemic and ensuing medicine shortages due to supply chain bottlenecks, the EC proposed the first major reform of its pharmaceutical regulations in April and hopes to forge a closer health union. A key short-term move is a voluntary mechanism between member states to fill medicine gaps across the block this winter, and creating a joint buying scheme for antibiotics and medicines for certain respiratory illnesses.

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