Voucher Program Looks Like a ‘Make-a-Deal’ Process: Experts

Leading health policy and regulatory experts are raising concerns over a new FDA review program that they say could politicize drug approvals and undermine scientific standards. The agency’s National Priority Voucher program is designed to accelerate FDA review times for certain drugs to as little as one to two months, with a one-day review meeting. But critics say the criteria for receiving these priority vouchers are vague, and that the program may favor companies that negotiate directly with the Trump administration.

In an opinion piece published on STAT, Harvard professors Daniel Carpenter, Thomas Hwang, and Aaron Kesselheim cite several instances in which pharmaceutical companies received vouchers after agreeing to concessions such as lowering drug prices. Among these, Eli Lilly and Novo Nordisk reportedly secured vouchers following private agreements to sell their GLP-1 drugs below list price. Similarly, EMD Serono received a voucher for an IVF treatment only after engaging in year-long discussions with the administration and agreeing to lower prices on existing therapies.

“These vouchers were announced not by the FDA, but at a White House press conference,” the authors write, noting that President Trump personally highlighted the deals. They contend that the program represents a sharp departure from previous FDA practices, which expedited drug review based on clear scientific criteria, including unmet medical needs, disease severity, or breakthrough therapies. Historically, priority review vouchers were tied to legislation passed by Congress and required demonstrable public health benefits.

Under the current program, they say, FDA decisions may be influenced by informal agreements or negotiations with companies, raising questions about transparency and fairness. The experts also note that the FDA has no statutory authority to consider drug pricing as part of approval decisions.

“Science has been replaced by barter and conformity to the vague standard of ‘national health priorities,’ interpreted on the fly,” according to the authors. They call on Congress to investigate the program and urge that procedural uniformity and transparency be restored to ensure that drug approvals remain based on rigorous evidence rather than political deals.