Fewer FDA Approvals of New Medicines

We Work for Health and Vital Transformation released a new study estimating that there would be 237 fewer FDA approvals of new medicines for patients battling cancer, neurological, and rare and infectious diseases (among others) over the next decade, as well as up to 1.1 million lost jobs if proposals to expand government-mandated drug pricing policies are implemented. Among the proposals under consideration is allowing Medicare to set prices for specific drugs five years after FDA approval, which would lead to devastating consequences for the biopharma ecosystem at an even more accelerated pace. These proposals are included in the White House’s FY 2024 budget as well as the Senate’s SMART Prices Act.

Key Highlights

The study found that if proposed expansions of government-mandated drug pricing policies are implemented, there would be serious consequences around the development of and investment in new medicines, as well as significant job losses in major innovation hubs across a number of states.

Lost Therapies: More than 80 currently available therapies of 121 identified for price setting – approximately 70% – would likely not have been developed had the pricing provisions been in place prior to their development.
Lost Innovation: There would be 237 fewer FDA approvals of new medicines or new uses over a 10-year period. Impacts of the proposed policies will be felt most heavily in many areas of unmet need, particularly in oncology, neurology, and rare and infectious diseases.
Lost Jobs & Investment: This would result in a loss of 146,000-223,000 direct biopharmaceutical industry jobs and a total loss of 730,000-1,100,000 U.S. jobs across the economy. There would be loss of ecosystem investments into 50 different therapeutic indications, concentrated primarily in California, Massachusetts and New York.

Please find the full report and supporting materials attached, and additional information can be found on the We Work for Health website.