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.
US FDA Appears To Quickly Renege On Next-Gen COVID Vaccine Guidance With Updated Booster Announcement
After issuing guidance and making public statements saying the first updated COVID-19 vaccines would require clinical trial data, agency picks new vaccine composition that will make obtaining such data highly unlikely before a planned fall booster campaign.