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ADAPT 2.0 Act
12/15/2023, 4:07 PM
Summary of Bill S 1132
The ADAPT 2.0 Act seeks to further enhance the rights and opportunities for individuals with disabilities by expanding access to affordable housing, increasing funding for disability services, and promoting the inclusion of individuals with disabilities in all aspects of society. The bill also aims to strengthen protections against discrimination based on disability and ensure that individuals with disabilities have equal access to education, employment, and healthcare.
Key provisions of the ADAPT 2.0 Act include the establishment of a national housing trust fund to increase the availability of affordable housing for individuals with disabilities, the creation of a national disability employment program to help individuals with disabilities find and maintain employment, and the implementation of measures to improve accessibility in public spaces and transportation. Overall, the ADAPT 2.0 Act is a comprehensive piece of legislation that seeks to address the needs and rights of individuals with disabilities in the United States. If passed, this bill has the potential to significantly improve the quality of life for millions of Americans with disabilities.
Congressional Summary of S 1132
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.
