Overview

Title

To direct the Comptroller General of the United States to conduct a study to assess the key regulatory barriers that impede the expansion or siting of new pharmaceutical manufacturing facilities in the United States, and for other purposes.

ELI5 AI

Imagine you have a puzzle that's really hard to put together because there are lots of confusing rules. H.R. 1405 is like a plan where grown-ups study these rules to see if they can find ways to make it less tricky for companies to build places that make medicine, so everyone can get the medicine they need more easily and quickly.

Summary AI

H. R. 1405, titled the "Enhancing Domestic Drug Manufacturing Competitiveness Act," directs the Comptroller General of the United States to conduct a study to identify the main regulatory barriers that hinder the expansion or establishment of new pharmaceutical manufacturing facilities in the country. The study will examine how these regulations compare to those in other countries, their impact on supply chain resilience, and potential actions to reduce these barriers. It will also explore technological solutions and policy support needed to overcome these obstacles. The findings and recommendations are to be reported to Congress within a year of the Act's enactment.

Published

2025-02-18
Congress: 119
Session: 1
Chamber: HOUSE
Status: Introduced in House
Date: 2025-02-18
Package ID: BILLS-119hr1405ih

Bill Statistics

Size

Sections:
2
Words:
641
Pages:
4
Sentences:
11

Language

Nouns: 183
Verbs: 61
Adjectives: 43
Adverbs: 3
Numbers: 18
Entities: 39

Complexity

Average Token Length:
4.53
Average Sentence Length:
58.27
Token Entropy:
4.59
Readability (ARI):
32.47

AnalysisAI

General Summary

The proposed legislation, known as the "Enhancing Domestic Drug Manufacturing Competitiveness Act," aims to commission a study by the Comptroller General to identify and assess key regulatory barriers hindering the expansion of pharmaceutical manufacturing facilities within the United States. The study examines regulatory impacts on costs, timelines, and supply chain resiliency while considering international competitiveness. The legislation intends to offer insights and recommendations for streamlining regulatory processes to bolster domestic pharmaceutical manufacturing capability.

Summary of Significant Issues

Ambiguity in Terminology

A core issue with the bill is its use of broad and subjective language, particularly concerning "key regulatory barriers" and "competitiveness." This vagueness could result in disparities regarding what the study should cover, potentially affecting the study's focus and effectiveness.

Financial Concerns

The absence of a specified budget cap for the study poses concerns about unchecked and potentially wasteful spending. Without clearly defined financial boundaries, there is a risk of resource misallocation.

Study Timeline

The bill's stipulation that the study and resulting report be completed within one year may not allow sufficient time for a thorough assessment. This period might lead to rushed conclusions or an incomplete analysis of the regulatory landscape.

Stakeholder Engagement

The bill lacks detail on how stakeholders will be chosen, which raises ethical concerns about potential bias. Ensuring a balanced and fair process is crucial to prevent favoritism towards specific groups.

Short Title Specificity

The title of the bill, while descriptive, lacks detail on particular mechanisms and scope, potentially leading to unclear policy objectives and implementation challenges.

Potential Broad Public Impact

The legislation aims to identify ways to make the U.S. more attractive for pharmaceutical manufacturing, which could lead to increased domestic production, reduced drug costs, and improved supply chain resiliency. These outcomes may benefit the general public by enhancing access to affordable medications and stabilizing supply availability. However, if the study's methodology lacks clarity or thoroughness, its practical impact may be limited.

Impact on Specific Stakeholders

Pharmaceutical Industry

For pharmaceutical companies, particularly those looking to expand or establish facilities in the U.S., this legislation could lead to a more favorable regulatory environment. By addressing and potentially reducing regulatory hurdles, companies could experience lower costs and quicker timelines for setting up manufacturing operations.

Environmental and Regulatory Bodies

These entities might view the proposal with caution, as recommendations for streamlining processes could potentially lead to reduced oversight. The challenge lies in balancing expedited approvals with maintaining rigorous safety and environmental standards.

Public Health Advocates

For organizations advocating for robust regulatory frameworks to ensure safety and environmental protection, the bill's focus on reducing regulatory barriers might raise concerns. They would likely emphasize the necessity of ensuring that expedited processes do not compromise public safety or quality standards.

In conclusion, while the proposed legislation holds promise for enhancing the domestic pharmaceutical landscape, its success hinges on addressing the noted issues with clarity and accountability to ensure that its benefits are realized equitably and effectively.

Issues

  • The broad and subjective language regarding 'key regulatory barriers' and competitiveness (Section 2) may lead to ambiguity and discrepancy in interpreting the study's scope, possibly affecting its effectiveness and focus.

  • The absence of a specified budget cap for the costs associated with the study (Section 2) could result in unchecked and potentially wasteful spending of resources, raising financial concerns.

  • The report deadline of not later than 1 year after the enactment (Section 2) might be insufficient for a comprehensive study, potentially leading to a rushed or incomplete assessment of the regulatory barriers.

  • The section on stakeholder engagement (Section 2) lacks details on the process for selecting stakeholders, risking bias if specific groups are favored or given more input, which raises ethical concerns.

  • The short title (Section 1) lacks specificity regarding the mechanisms and scope of the Act's objectives, which could lead to unclear policy objectives and potential challenges in implementation and accountability.

Sections

Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.

1. Short title Read Opens in new tab

Summary AI

The first section of this bill states that the official name of the legislation is the “Enhancing Domestic Drug Manufacturing Competitiveness Act”.

2. Study on key regulatory barriers to expanding pharmaceutical manufacturing in the United States Read Opens in new tab

Summary AI

The Comptroller General is tasked with studying the main regulatory obstacles that hinder the growth of pharmaceutical manufacturing in the U.S. and make it less competitive internationally. The study will look into how regulations affect costs and timelines, potential impacts on the supply chain, and identify solutions. A report with findings and recommendations will be submitted to Congress within a year.