Pharmalittle: FDA finds problems at Novo’s main U.S. factory; polarizing ALS drug heads for FDA scrutiny

Hello, everyone, and how are you this fine, sunny morning? We are doing just fine, thank you, especially now that the usual rush hour din has settled down and the official mascots are snoozing in their respective corners. This provides an opportunity to fire up the trusty coffee kettle for another cup of stimulation. Our choice today is maple bourbon. Please feel free to join us. Meanwhile, here are the latest tidbits for you to peruse. We hope you have a meaningful and productive day, and conquer the world….

The threat of a massive tax is enough to push some drugmakers to comply with the Biden administration’s drug pricing law and negotiate with Medicare, Bloomberg Law says. Under the Inflation Reduction Act, those that refuse to comply with negotiations must pay a tax starting at 65% of the U.S. sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%. The Internal Revenue Service is expected to issue a proposed rule, but companies are not waiting on guidance, because they do not see it in their best interest to reject negotiations. The Congressional Budget Office estimated it could exceed profits on a drug when combined with corporate income taxes.

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Meanwhile, House lawmakers fought it out over Medicare drug price negotiation at a hearing, with Republicans accusing Democrats of setting up “mafia-style” theft of property, STAT tells us. Typically, intense hearings like the one before the House Energy and Commerce subcommittee take place when lawmakers are debating legislation, not well after a law passes. During the session, oversight subcommittee Chair Morgan Griffith (R-Va.) also compared the provision of federal law that allows Medicare to negotiate prices for some drugs to the theft of American property by British officers before the American Revolution.

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