Winners and Losers In Democrat’s Mega Social Spending Package
Industry almost certain to avoid its worst pricing reform fears, but some post-exclusivity drugs may still be subject to negotiations under the most recent iteration of Build Back Better. Meanwhile, rare disease development incentives get cut and new funding is doled out for FDA.
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The legislation would also establish new manufacturer discounts in Medicare Part D as part of a redesign of the benefit that includes a cap on beneficiary out-of-pocket spending. Negotiations are still fluid on the overall legislative package, however, and things could change.
Medicare Price Negotiation Lite? Congress Targets Post-Exclusivity Drugs, Preserves Launch Price Discretion
Legislative deal on drug pricing reform includes a version of US government price negotiation for a subset of Medicare drugs. Only 10 will be selected for negotiation the first year but some analysts believe as many as 100 could be subject to negotiation by 2030.
Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.