Regulatory Relief To Promote Domestic Production Of

The Executive Order aims to enhance domestic pharmaceutical production in the U.S. to improve health security and remedy prior inadequacies.

The previous administration made insufficient progress in establishing a resilient pharmaceutical supply chain, leading to critical information gaps.

Key issues affecting pharmaceutical manufacturing include:

• Lengthy construction timelines (5 to 10 years).
• Complex federal, state, and local regulatory requirements.
• Frequent FDA inspections of domestic manufacturers compared to international counterparts.

The Administration intends to eliminate regulatory barriers to enhance domestic production capabilities and make the U.S. a competitive manufacturing hub.

The Secretary of Health and Human Services is tasked to:

• Review existing regulations and guidance for domestic pharmaceutical manufacturing within 180 days.
• Streamline and accelerate regulatory processes, ensuring efficiency in inspections and approvals, especially for new technologies and production facilities.

Specific responsibilities of the FDA Commissioner include:

• Evaluating and improving the current risk-based inspection approach, ensuring compliance with the Federal Food, Drug, and Cosmetic Act.
• Enhancing programs to provide early technical advice to potential manufacturing facilities.
• Improving enforcement of data reporting related to compliance.
• Providing clearer guidance on site changes and component validations associated with domestic production.

Within 90 days, the FDA Commissioner will:

• Develop improvements to the inspection regime for foreign manufacturing facilities, with funding from increased fees.
• Publicly disclose detailed inspection data for foreign facilities.

The Administrator of the EPA will update regulations pertaining to pharmaceutical manufacturing inspections within 180 days to enhance efficiency and reduce redundancy.

The Secretary of the Army will evaluate nationwide permits related to waterway regulations to support efficient pharmaceutical facility permitting within 180 days.

General provisions include:

• The Order does not alter the authority of existing agencies.
• Implementation is subject to applicable laws and funding availability.
• The Order does not confer enforceable rights against the U.S. or its entities.