Policy Impact Analysis - 117/HR/6483

Bill Overview

Title: Improved Transparency of Foreign Drug Manufacturing Act of 2022

Description: This bill modifies requirements for certain foreign establishments that manufacture drugs (including active pharmaceutical ingredients) to register with the Food and Drug Administration (FDA). Under this bill, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States. A non-U.S. manufacturing establishment must also file with the FDA a list of drugs manufactured by the establishment. For each drug on the list, the establishment must (1) identify every other known establishment where additional manufacturing is performed, and (2) notify each foreign establishment involved of the listing of the drug and the obligation to register with the FDA. The bill also requires each registered non-U.S. manufacturing establishment to report every three months to the FDA a list of each drug it manufactures for commercial distribution, where currently this report is required once a year.

Sponsors: Rep. Eshoo, Anna G. [D-CA-18]

Target Audience

Population: Individuals worldwide relying on pharmaceuticals imported into the United States

Estimated Size: 200000000

• The bill targets foreign drug manufacturing establishments that provide drugs or active pharmaceutical ingredients for the U.S. market, which predominantly affects international manufacturing and supply chains.
• Increased regulatory requirements may indirectly affect consumers worldwide as some of these manufacturing costs could be passed down.
• It aims to increase transparency and possibly the quality assurance for drugs entering the U.S. which affects healthcare efficacy and safety.
• The pharmaceutical industry, including workers, consumers, and regulatory bodies outside the U.S, will be involved in meeting the new compliance outlines.

Reasoning

• The bill aims to increase transparency and regulatory oversight of drug manufacturing globally, impacting both health care providers and consumers in the U.S.
• Approximately 66% of U.S. adults use prescriptions, which may be subject to increased costs or availability changes due to compliance costs on foreign manufacturers.
• People who are reliant on imported medications might experience changes in their access or costs. This may result in fluctuations in their wellbeing scores.
• The effects on pharmaceuticals and drugs can indirectly affect healthcare workers who rely on timely access to these medicines for patient care.
• Some demographic groups, such as the elderly who depend more heavily on medications, may perceive greater impacts.

Simulated Interviews

Cost Estimates

Key Considerations

• Effectiveness in increasing transparency and safety within the pharmaceutical supply chain.
• Potential compliance and operational costs for foreign manufacturers.
• Implications on drug pricing and access for U.S. consumers.
• Coordination challenges with foreign regulatory bodies.
• Efficiency in data handling and updating systems for quarterly reports.