180-Day Exclusivity Changes Pushed In Biden’s Budget Proposal
The legislative proposal would make first-filer exclusivity function similar to the competitive generic therapy program, allowing additional approvals if the commercial launch is delayed.
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The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.
Senate Drug Pricing Legislation Clears Committee With Generic Exclusivity “Parking” Provision Unchanged
US Senate health committee advanced the Lower Health Care Costs Act with few pharma-related changes. Bill’s drug pricing provisions include the CREATES Act and a requirement that manufacturers report to HHS on price increases.