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Latest From Michael McCaughan
The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.
Success of drug industry’s campaign to highlight role of 'middlemen' in the supply chain was never more clear than during President Trump’s Rose Garden drug pricing event. But what happens now that the attention is turned squarely back on manufacturers?
US Senate Democrats are eager to bring in prescription opioid manufacturer executives for a hearing that would recreate the famous image of tobacco industry CEOs being sworn in by Congress. That moment probably won’t come this year – but may be inevitable before the opioid abuse crisis can be declared over.
US FDA’s decision to rescind refuse-to-file letter for Alkermes’ high-profile depression drug is extremely unusual – but not literally unprecedented. One prior example of rescinding an RTF involves an ANDA.
Abuse-deterrent formulations are 'potentially useful tool,' but CMS believe it lacks authority to mandate favorable coverage in Part D plans. House E&C committee has nearly three dozen Medicare & Medicaid proposals under consideration – but none that specifically gives CMS the authority it says it needs.