Overview
Title
Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER
Agencies
ELI5 AI
The FDA checked how long it took to approve a special medicine called XTAMPZA ER, used for pain, to see if they can give it more time before others can copy it. People can say if they agree or disagree with how the FDA measured this time.
Summary AI
The Food and Drug Administration (FDA) has determined the regulatory review period for the drug XTAMPZA ER, which is used for managing severe pain requiring long-term opioid treatment. This review is necessary for a possible extension of the drug's patent, as requested by Collegium Pharmaceutical, Inc. The review period comprises 3,214 days, with 2,712 days for testing and 502 days for approval. The FDA invites comments on this determination and allows for petitions if there are disagreements concerning the information or the due diligence during the review process.
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTAMPZA ER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 drug product.
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Sources
AnalysisAI
Overview of the Document
The recent notice from the Food and Drug Administration (FDA), published in the Federal Register, details the regulatory review period for a pharmaceutical product known as XTAMPZA ER. This medication is significant in managing severe pain that requires long-term opioid treatment when alternative methods are insufficient. The document outlines the FDA's determination of the review period as part of procedures for extending the drug's patent, which has been appealed by Collegium Pharmaceutical, Inc.
The regulatory review period, vital for understanding the potential length of a patent extension, spans a total of 3,214 days. This breaks down into 2,712 days dedicated to testing the drug and an additional 502 days for approval. The FDA is seeking public engagement through comments and petitions, allowing stakeholders to contest the published dates or the diligence exhibited during the review process.
Notable Issues and Concerns
One significant issue the document poses is the complex and technical jargon used, which could alienate readers unfamiliar with legal or pharmaceutical terminology. The details surrounding patent extensions and regulatory review periods are not easily digestible for a general audience, potentially hindering transparency and public understanding.
Additionally, there is an obscurity concerning the role and evaluation criteria used by the United States Patent and Trademark Office (USPTO) in awarding these extensions. This lack of clarity might make the decision-making process appear less transparent or understandable to the public or affected parties.
While the document does offer a means for public participation in commenting on the regulatory review period, it does not clarify how to access results from these comments or petitions. This lack of feedback could dissuade public engagement and contribute to a perception that the process is inaccessible.
Furthermore, the document may appear biased as it highlights patent extension applications for Collegium Pharmaceutical, Inc. specifically, without mentioning opportunities for other companies. This concentration on one company might be perceived as preferential treatment.
Impact on the Public and Stakeholders
For the general public, this document underscores the bureaucratic processes involved in drug patent extensions, which can indirectly impact drug pricing and availability. The length of a drug’s patent can influence market competition and, consequently, the affordability of medications.
Specific stakeholders, such as patients relying on XTAMPZA ER, might view the potential patent extension positively as it could ensure continued access to their medication. On the other hand, potential competitors to Collegium Pharmaceutical, Inc. may see this extension negatively as it limits their ability to introduce generic versions of the drug to the market, potentially stifling competition.
Patients and healthcare providers may also be concerned about drug costs. Patent extensions can delay the entry of cheaper, generic versions of a drug into the market, keeping prices high and affecting affordability for consumers. As such, the document implicitly raises concerns about balancing innovation incentives with consumer access to essential medications.
Conclusion
Overall, while the FDA's determination of the regulatory review period for XTAMPZA ER is a critical procedural step, the document's language and focus might alienate the general public. The intricacies surrounding patent extensions require careful navigation to ensure that processes remain fair, transparent, and beneficial to broader stakeholder groups, including both pharmaceutical companies and consumers. Addressing the ambiguous aspects of the document and fostering open discussion could improve public understanding and participation in such regulatory matters.
Issues
• The document contains complex and technical language related to patent extension and regulatory review periods, which may be difficult for the general public to understand.
• The document does not explicitly clarify the role and criteria used by the USPTO in determining patent extensions, which might make the decision-making process seem opaque.
• While the document provides detailed instructions for submitting comments and petitions, there is a lack of clarity on how the public can access the results of any petitions or comments submitted.
• The document might be perceived as favoring Collegium Pharmaceutical, Inc. since it details patent extension applications for their drug XTAMPZA ER without mentioning any similar opportunities for other companies.
• There is no information provided on the cost implications of the patent extension process or how it affects drug pricing or access for consumers.
• The issue of whether the applicant acted with due diligence during the regulatory review period is open for petition, but there are no examples or guidelines provided on what constitutes due diligence.
• The document refers to various CFR sections and Federal Register notices without summaries or explanations, requiring readers to seek them out separately for full understanding.