Sunday, April 6, 2025

Two News Items: (1) FDA PDUFA in Jeopardy?? (2) Tariffs versus Fixed Payment Prices

Two items from the national news this week.

PDUFA, MDUFA - AT RISK?

In a Linked In article, accompanied by an 8-page PDF from AGENCY-IQ, the consultancy argues that PDFUA and MDUFA dollars - which fund half the FDA - could be at risk.   "Exploding" clauses in the statutes require that FDA hit certain spending and performance targets must be met by FDA, or else, all the monies go back to industry.  

For details see here:

https://www.linkedin.com/posts/ccmiles_the-future-of-fdas-user-fee-programs-ugcPost-7313907487147970560-hC-N/ 

TARIFF PRICE HIKES VS FIXED MEDICAL PAYMENTS

As reported in Forbes and elsewhere, large tariffs, if left in place, could substantially raise the cost of medical equipment and supplies (from pacemakers to insulin pumps).  But hospitals and physicians are generally paid at fixed fee schedules by Medicare and under other contracts.   At least in the case of physicians, those fee schedules already substantially lag inflation (as emphasized by AMA and others).   This means that tariff fees are "a rock hitting a hard place" in terms of payments.  

Forbes here:

https://www.forbes.com/sites/amyfeldman/2025/04/04/trumps-tariffs-could-raise-the-price-of-pacemakers-and-insulin-pumps/