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Latest From Michael McCaughan
CMS has abandoned its plan to give private plans more leverage in the “protected” drug classes in Part D. It will probably be a long time before anyone tries to change the protected classes again.
US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.
Acting commissioner is entering the usual learning curve for new leaders of the agency. It’s a reminder of how unusual it was to skip that step under his predecessor.
For years, brand industry critics have decried the use of “sham” citizen petitions to delay generic drug approvals. But one person’s “sham” is another person’s First Amendment right to petition the government. A House bill tries to thread that needle.