FDA Becomes a Tool of Industrial Policy: Priority Vouchers, PreCheck and the 100% Pharma Tariff That Most Big Drugmakers Avoid
On 1 April 2026 the FDA approved Eli Lilly’s Foundayo, an obesity pill, 50 days after the company filed. Standard reviews take about ten months. The speed came from a Commissioner’s National Priority Voucher, a programme launched in June 2025 that promises reviews in one to two months for drugs the agency judges to serve national priorities. Two of the first nine vouchers went to products made in the US.
Foundayo’s approval shows how the FDA has been folded into the administration’s trade and manufacturing strategy. The agency now rewards companies that make drugs in America, and tariffs penalise those that don’t.
The FDA’s levers
The priority voucher programme started small. The original plan was five vouchers. Nine were announced in October 2025, 18 had been awarded by April 2026 and at least 22 by June. A public hearing on the programme was held in June 2026.
PreCheck, announced in August 2025, is aimed directly at new plants. It gives companies building US manufacturing sites early engagement with the FDA, so facility questions get settled before the drug application. The pilot opened in February 2026, drew more than 80 requests in a month, and by July had selected seven companies, including Eli Lilly, Regeneron, Amneal and Fujifilm.
The FDA also changed how it treats foreign plants. In May 2025 it said it would expand unannounced inspections abroad. Foreign facilities had typically had up to twelve weeks’ notice. Domestic plants have long been inspected without warning.
The tariff
The Commerce Department supplies the penalty. Under a Section 232 proclamation of 2 April 2026, patented drugs and their active ingredients face a 100% tariff. Imports from the EU, Japan, South Korea, Switzerland and Liechtenstein pay 15%. Generics, biosimilars and orphan drugs are excluded for now. The tariff started on 31 July for one group of companies and on 29 September for everyone else.
Most big drugmakers won’t pay it. Companies with an approved plan to build in the US pay 20% until 2030. Those with a US manufacturing plan and a deal to sell drugs at “most favoured nation” prices, matching the lowest prices paid abroad, pay nothing until January 2029. Pfizer signed the first such deal in September 2025, pledging $70 billion in US research and manufacturing and joining a government site, TrumpRx.gov, that sells drugs at discounts. By the end of August 2026, 26 manufacturers had deals, covering 89% of the branded drug market.
What it adds up to
The combined effect is a trade: lower US prices and more US factories in return for tariff relief and faster regulatory treatment. It’s industrial policy run through the drug regulator and the trade law at once.
That has costs to watch. Priority vouchers reward policy goals that aren’t strictly about safety or effectiveness, which critics say risks politicising review. A tariff that most large companies escape falls hardest on smaller importers. And manufacturing pledges take years to become plants.
Europe has tried to reshore drug production too, mainly through subsidies and stockpiling rules after the shortages of the pandemic. The US approach is more aggressive: it uses market access itself as the lever. Whether that produces more American plants or mainly cheaper prices for a few years will show by 2029, when the zero-tariff deals start to expire.