Overview
Title
Determination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE
Agencies
ELI5 AI
The FDA looked at how long it took to check and approve a special medicine called OMISIRGE that helps fight some blood cancers. They found that this took a long time, and now they're thinking about giving the makers a little more time for their special recipe (patent) to stay theirs and not be copied by others.
Summary AI
The Food and Drug Administration (FDA) has determined the regulatory review period for a human biologic product named OMISIRGE, which is used for treating certain blood cancers. The review period, which is 4,563 days long, involves a testing phase and an approval phase and influences the potential extension of the product's patent. The FDA's decision follows an application by Gamida Cell Ltd. for patent extension, and the public can provide comments or request further determinations by specified deadlines.
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OMISIRGE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
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AnalysisAI
Editorial Commentary
General Summary
The document provides a detailed account of the Food and Drug Administration's (FDA) determination of the regulatory review period for a human biologic product called OMISIRGE. OMISIRGE is a treatment for certain blood cancers and has been approved for use in adults and pediatric patients aged 12 years and older. The review period, totaling 4,563 days, plays a crucial role in determining the potential extension of the patent held by Gamida Cell Ltd. A complex process is outlined for public comments and petitions regarding the review period, with specific deadlines.
Significant Issues and Concerns
Several issues emerge from the document that may hinder public engagement and comprehension:
Complexity of Submission Process: The document's instructions for submitting comments and petitions, both electronically and in writing, involve intricate steps that may confuse or discourage participation from those unfamiliar with regulatory procedures.
Confidential Information Submissions: The requirement for two separate submissions when comments contain confidential information could be daunting for individuals unaccustomed to legal formalities.
Clarity on Patent Extension Limitations: The reference to the U.S. Patent and Trademark Office's (USPTO) "several statutory limitations" lacks clarity regarding their impact on the actual calculation of the patent extension period.
Technical Language: Legal and regulatory jargon, such as references to the Code of Federal Regulations, can be challenging for laypersons to understand, potentially limiting public comprehension of the document's implications.
Explanation of Review Period: The document could simplify the explanation of how the 4,563 days were determined for the regulatory review period, making it more accessible to a general audience.
Understanding 'Due Diligence': The mention of 'due diligence' in the context of the patent extension application is vague, leaving readers without a clear understanding of what qualifies or constitutes due diligence.
Public Impact
Broadly, this document is an example of how the FDA communicates regulatory decisions that affect public health. The determination of the regulatory review period is essential for the public because it influences the duration of market exclusivity for new treatments, potentially affecting drug prices and accessibility. By enabling public comment, the FDA theoretically empowers individuals and organizations to participate in the regulatory process.
Impact on Specific Stakeholders
Pharmaceutical Companies: For entities like Gamida Cell Ltd., the determination of the regulatory review period and subsequent patent extension is vital for securing financial returns on their investments in drug development. A positive determination extending the patent period can significantly benefit companies.
Patients and Healthcare Providers: Patients relying on treatments like OMISIRGE might experience indirect effects, such as changes in drug availability and affordability, depending on the patent extension's outcome. Healthcare providers might need to stay informed about any potential impacts on prescribed treatments.
Legal and Regulatory Professionals: These stakeholders may see this document as part of a larger puzzle in navigating regulatory approvals. The nuances and technical details lie firmly within their area of expertise.
The document exemplifies the complexity and critical nature of FDA decisions in the continuum of drug development, market access, and patent law, impacting various segments of society in multifaceted ways.
Issues
• The document provides a detailed process for submitting comments and petitions, but the complexity of the URLs and process steps may discourage participation from individuals unfamiliar with regulatory language.
• The process for submitting comments with confidential information requires submitting two separate versions, which might be overly complex for individuals not accustomed to legal or regulatory submissions.
• It is unclear from the document how the USPTO's 'several statutory limitations' affect the actual period for patent extension calculations.
• The document contains technical legal references and citations to laws and regulatory standards (e.g., 21 CFR 10.20, 21 CFR 60.24) that could be difficult for laypersons to interpret.
• The rationale behind the specific determination of 4,563 days for the regulatory review period could be explained in simpler terms for better public comprehension.
• The document briefly mentions the term 'due diligence' regarding the extension application but provides limited information on what constitutes due diligence in this context.