US Medicare Price Negotiation: Gaming FDA Approval Dates Could Delay Drug Selection
The early February date for publishing the list of products eligible for price negotiations could dictate approval strategies for drugs with potential for big sales in Medicare going forward.
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The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.
Congressional Democrats achieved a long-sought goal in passing major legislation to control drug prices in Medicare. A complete lack of Republican support suggests the programs established by the bill will face the same kind of legislative and legal challenges that confronted the Affordable Care Act, which was enacted in a similar manner.
There was lots of criticism of pharmacy benefit managers (and a fair amount of pharmaceutical manufacturers) at the oversight hearing. However, Democrats may be more cautious about preserving the benefits PBMs provide versus the downsides in developing reforms.