The 30+ year-old program, which monitors prenatal exposure to 164 drugs, should be the template for other efforts, US FDA officials say, because disease-based pregnancy registries ‘have a better track record.’

US government may add provisions to future agreements to ensure its inventorship rights and make terms more favorable to the public. Lawyers say it will be difficult for Moderna to exclude NIH as co-inventor. But NIH lost a similar battle over AZT patents.

The agency’s quickest approvals include two in 2020 – Gilead’s Veklury and Seattle Genetics’ Tukysa – but two 1990s AIDS drugs are at the top of the list.