Policy Impact Analysis - 117/S/3509

Bill Overview

Title: Creating Efficiency in Foreign Facility Inspections Act

Description: This bill prohibits, with some exceptions, the Food and Drug Administration (FDA) from providing notification in advance of a planned inspection of an establishment located outside of the United States that is engaged in drug manufacturing, processing, packing, or holding. Specifically, the FDA may not provide such an establishment advance notification of a planned inspection unless (1) advance notification is required by the laws of the country where the establishment is located; (2) providing advance notification is needed to protect the public health; or (3) the inspection in question is a preapproval, prelicensure, or for-cause inspection. If the FDA must provide advance notification, it must minimize the time between the notification and the inspection. If an establishment is located in a country that, on or after the date this bill is enacted, enacts a law requiring advance notification of inspections, the drug manufacturer must agree to waive the right to enforce the requirement, to the extent expressly permitted by the law.

Sponsors: Sen. Braun, Mike [R-IN]

Target Audience

Population: People consuming drugs from foreign facilities inspected by the FDA

Estimated Size: 330000000

• The bill affects drug manufacturing establishments located outside the United States. These establishments are responsible for producing drugs that may be marketed and consumed worldwide, which includes the U.S.
• The FDA's inspections are critical for ensuring that manufacturing practices meet U.S. standards, thus influencing the quality and safety of drugs available to U.S. consumers.
• Global pharmaceutical supply chains are complex and interconnected, and changes in inspection protocols can impact drug availability and safety globally.
• Consumers of medications manufactured outside of the U.S. could be affected if inspection frequency or effectiveness changes.
• U.S. consumers are directly affected by the quality and safety of drugs approved by the FDA, as they consume these pharmaceutical products.

Reasoning

• Given the policy affects drug manufacturing in foreign establishments, the primary U.S. population impacted includes consumers of medications, which technically encompasses most Americans since few modern medications are produced entirely domestically.
• The budget constraints limit the scope of FDA's increased inspection frequency or comprehensiveness, hence not all drug categories might experience improved inspection rigor.
• Those dependent on medications, such as individuals with chronic conditions, or the elderly, might perceive an improvement in their wellbeing due to anticipated improvements in drug safety from more rigorous inspections.
• There will be individuals and groups who remain unaffected by these changes due to reasons like their preferred drugs being manufactured domestically or from tightly regulated foreign facilities.
• The policy doesn't directly alter U.S. pricing of pharmaceuticals, so people primarily concerned with drug affordability might not register any difference in wellbeing.

Simulated Interviews

Cost Estimates

Key Considerations

• Ensuring international cooperation is essential to mitigate negative effects on access to inspections.
• There will need to be provisions to handle countries with firm pre-notification requirements effectively.
• Potential trade implications and diplomatic considerations must be addressed appropriately.
• Balancing the need for stringent inspections with the practicalities of operational activities in diverse global settings.