The globalization of the pharmaceutical market has created tremendous challenges for the U.S. Food and Drug Administration (FDA), including dramatic increases in drug imports, complex and fragmented global supply chains and increasing threats of fraudulent and substandard drugs. Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) gives FDA new authorities to address these challenges and better ensure the safety, effectiveness and quality of drugs imported into the United States.
Implementation of these authorities will significantly advance the globalization strategies set forth in FDA’s Pathway to Global Product Safety and Quality report and support FDA's ongoing quality-related initiatives. These authorities will allow FDA to collect and analyze data to make risk-informed decisions, advance its risk-based approach to facility oversight, strengthen its partnerships with foreign regulators, and drive safety and quality throughout the supply chain through strengthened tools. At the same time, implementation of Title VII of FDASIA is difficult and complex, and requires not only the development of new regulations, guidances and reports, but also major changes in FDA information systems, processes and policies.
FDA is working diligently through this challenging implementation, prioritizing its efforts to achieve the greatest public health impact and deploy its limited resources most effectively. Stakeholder input and feedback is critically important as FDA determines how best to implement these important new authorities.
- Full text of the FDASIA Statute
- Overview of FDASIA Title VII
- Proposed and final rule regarding administrative destruction of imported drugs refused admission into the U.S.
- Annual Reports outlining the number of domestic and foreign establishments registered and inspected and the percentage of the FDA budget used to fund such inspections
- Proposed amendment to sentencing guidelines submitted to Congress
- Proposed and final rule to extend the agency's administrative detention authority to include drugs, in addition to the authority that is already in place for foods and devices
- Final guidance defining conduct the agency considers delaying, denying, limiting or refusing inspection, resulting in a drug being deemed adulterated
- July 2013 Public Meeting regarding the agency’s implementation of Title VII, including video, presentations and meeting transcript
- Plan for Preventing and Mitigating Drug Shortages
- FDA Fact Sheet: Drug Shortages in the United States
- Draft and final guidance specifying the unique facility identifier (UFI) system for drug establishment registration.