ADAPT 2.0 Act

The ADAPT 2.0 Act (S 1132) allows U.S. drug manufacturers to seek approval for new drugs using clinical and safety data from countries where the drug is already approved, such as the United Kingdom and South Africa. It requires the FDA to review these applications within 90 days and automatically approve them if the drug meets specific criteria, including being approved in the foreign country, safe, effective, and meeting manufacturing and patent requirements. The bill mandates the FDA to establish a new Foreign Drug Review Advisory Committee to evaluate applications within 60 days and publish approval decisions online. It also requires sponsors to conduct post-approval studies for certain drugs and submit promotional materials for review before dissemination. This law directly affects drug manufacturers seeking faster U.S. market access and the FDA’s review process for foreign-approved therapies.