Overview
Title
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
Agencies
ELI5 AI
Janssen Pharmaceuticals wants permission to make special medical ingredients, and the government is asking people to share their thoughts about this by April 21, 2025.
Summary AI
Janssen Pharmaceuticals, Inc. has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The DEA has issued a notice inviting public comments or objections to this application and requests for a hearing on the matter, which must be submitted by April 21, 2025. Comments can be made electronically through the Federal eRulemaking Portal. Janssen plans to manufacture these substances for use as intermediates in sales to customers, and no other activities are allowed under this registration.
Abstract
Janssen Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Keywords AI
Sources
AnalysisAI
The document under review is an official notice from the Drug Enforcement Administration (DEA), announcing that Janssen Pharmaceuticals, Inc. has applied to register as a bulk manufacturer of certain controlled substances. This notice provides an opportunity for public comments or objections and requests for a hearing to be submitted by April 21, 2025. The comments can be made electronically through the Federal eRulemaking Portal.
General Summary
The notice informs the public about Janssen Pharmaceuticals' intention to manufacture controlled substances in bulk quantities, specifically for internal use intermediates intended for customer sales. The document outlines the procedural aspects for members of the public or interested parties who wish to voice support, opposition, or concerns regarding this application. It establishes a framework for transparency and public participation in the regulatory process by inviting comments through an accessible online platform.
Significant Issues or Concerns
Several concerns are evident in the document:
Lack of Specificity: The notice does not specify which controlled substances Janssen Pharmaceuticals intends to manufacture. This lack of detail limits stakeholders' ability to assess the implications and potential impact of this registration accurately.
Impacts and Implications: The document offers no discussion on the potential impacts or implications of allowing Janssen Pharmaceuticals to register as a bulk manufacturer. This absence of information may hinder public understanding and interest in providing meaningful feedback.
Criteria for Approval: Without details on the criteria or standards that will guide the DEA's decision-making process, there is potential ambiguity in what factors will influence the approval of Janssen Pharmaceuticals' application.
Clarification of Terminology: The description of the end-use of these substances as "internal use intermediates for sale to its customers" is vague. It does not specify what this entails or who the customers are, leading to uncertainty about the ultimate use of the manufactured substances.
Utilization of Public Comments: The document lacks clarity on how submitted public comments will influence the decision-making process, potentially making the solicitation seem less transparent and discouraging public participation.
Impact on the Public and Stakeholders
Broad Public Impact: While the document invites public participation, the lack of detailed information could limit effective engagement. The public is encouraged to comment but may not fully understand the stakes or consequences involved with such a registration.
Impact on Specific Stakeholders: For stakeholders such as existing registered manufacturers, healthcare professionals, consumer safety advocates, and potential competitors, the ambiguity in specific substances and regulatory criteria may create uncertainty. The lack of transparent criteria could result in stakeholders feeling inadequately informed to evaluate or respond to the application effectively.
In conclusion, while the DEA's effort to solicit public feedback is commendable, the document could be improved by providing more detailed information and clearer explanations of terms and processes involved. This would facilitate a more informed and constructive public dialogue and engagement with the decision-making process.
Issues
• The document lacks specific details on which controlled substances Janssen Pharmaceuticals, Inc. intends to manufacture, making it difficult for stakeholders to assess the impact of the application.
• The notice does not provide details about the potential implications or impact of registering Janssen Pharmaceuticals, Inc. as a bulk manufacturer. This may limit public understanding or concern.
• Specific criteria or standards for approval of the application are not discussed, potentially leading to ambiguity regarding what will influence the decision-making process.
• The text refers to 'internal use intermediates for sale to its customers' without clarifying what this entails or which customers are involved, which might result in uncertainty about the end-use of these controlled substances.
• There is no information or data provided about how public comments will be utilized in the decision-making process, potentially rendering the comment solicitation less transparent.