The ADAPT 2.0 Act speeds up how quickly new drugs can get FDA approval by allowing drug makers to use research studies that were already completed in other countries. Specifically, if a drug has already been approved and studied in countries like Canada, Australia, the UK, Japan, or the European Union, a company can submit that foreign research as part of their application to sell the drug in the United States—instead of having to repeat all the studies from scratch.

This change is designed to get new medications to American patients faster. However, the FDA still has safeguards in place. The agency has 90 days to review and approve or reject these applications, and if they don't make a decision within that timeframe, the drug is automatically approved. The FDA can also require companies to do additional studies after the drug hits the market and must review all advertising materials before they're used.

The bill also creates an advisory committee that reviews each application using foreign research and provides recommendations to the FDA. All decisions on these applications, along with the reasoning behind them and the committee's advice, must be posted publicly on the FDA's website so patients and doctors can see how these decisions were made.

ADAPT 2.0 Act

Braun, Mike

Accelerated Drug Approval for Prescription Therapies 2.0 Act or the ADAPT 2.0 Act This bill allows applicants seeking Food and Drug Administration (FDA) approval to market a new drug to rely on investigations conducted in certain other countries and addresses related issues. If an applicant seeks market approval for a new drug with an application that relies on at least one investigation that the applicant did not conduct and did not obtain approval to use, the applicant may rely on an investigation that was conducted in certain foreign countries if the drug in question has already been approved in that country. The investigation must have been conducted in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, the European Union, a country in the European Economic Area, or another country that the FDA has found to meet certain requirements. The FDA must make a decision on such an application within 90 days of the application's filing. If the FDA does not take certain actions within that period, the application shall be considered approved. The FDA may require the applicant to conduct postapproval studies of the drug and to submit copies of all promotional materials. The bill also establishes an advisory committee to provide the FDA with recommendations as to each application that relies on a foreign investigation. The FDA must make available on its public website each decision on such an application, including the rationale for the decision and the advisory committee's recommendations.