Overview
Title
Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY
Agencies
ELI5 AI
The FDA checked how long they tested and reviewed a medicine called BYLVAY before deciding it was safe for people to use, and they are letting others know how they calculated this time. If anyone thinks they made a mistake with these dates, they can say so, and the FDA will look into it.
Summary AI
The Food and Drug Administration (FDA) has announced its determination of the regulatory review period for the human drug BYLVAY. The FDA made this determination following a request from the U.S. Patent and Trademark Office for information related to patent term restoration. BYLVAY, approved for treating pruritis in patients aged 3 months and older with progressive familial intrahepatic cholestasis, underwent 1,868 days of regulatory review, including a testing phase of 1,625 days and an approval phase of 243 days. This notice invites anyone with information suggesting that these dates might be incorrect to submit their comments for consideration.
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BYLVAY 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.
Keywords AI
Sources
AnalysisAI
The document in question is an official notice from the U.S. Food and Drug Administration (FDA) regarding the determination of the regulatory review period for a drug called BYLVAY. This determination is part of a process connected to patent extensions, which can have important implications for drug manufacturers and the availability of medications.
General Summary
The FDA has reviewed the regulatory timeline of BYLVAY—a medication used to treat pruritus (a symptom of itching) in young patients with a rare liver condition. The notice confirms the total review period was 1,868 days, split into a testing phase of 1,625 days followed by an approval phase lasting 243 days. These details were published as part of an official protocol to support the U.S. Patent and Trademark Office (USPTO) in its decision regarding the potential extension of a patent term for this drug. The document invites stakeholders to submit comments if they have information suggesting the posted dates are inaccurate.
Significant Issues or Concerns
Several notable issues emerge from this document. Firstly, the criteria for assessing whether an applicant has acted with due diligence during the drug's review process are somewhat unclear. This could create confusion for petitioners wishing to challenge the determination.
Additionally, the process for submitting different types of comments is rather complex. The document distinguishes sharply between confidential and non-confidential submissions, potentially causing confusion for those unfamiliar with regulatory processes.
Moreover, the outlined regulatory review and patent extension processes might seem overly technical to a general audience. Simplifying these explanations or providing summaries could improve understanding.
Finally, the document does not specify whether the requested patent term extensions of 630, 679, or 861 days were granted. This information gap leaves readers uncertain about the outcome of the patent extension application.
Impact on the Public
For the general public, this document primarily represents transparency in regulatory processes, which is crucial for maintaining public trust. Understanding how long it takes for a drug to be thoroughly reviewed can alleviate concerns about drug safety and efficacy. However, the complexity of the information may limit its accessibility for those without specialized knowledge.
Inaccuracies in reported dates, if not corrected, could influence the overall trust in regulatory processes. Thus, the document's invitation to comment serves as a necessary check on transparency and accountability.
Impact on Specific Stakeholders
Pharmaceutical Companies: For drug manufacturers, the determination is critical as patent extensions can significantly impact a product's market exclusivity and profitability. Accurate regulatory reviews and patent terms can affect investment in drug development and innovation.
Healthcare Professionals: Physicians and healthcare providers may be influenced by the availability of medications like BYLVAY, as patent extensions affect when generic versions become available. This can impact treatment options and costs for patients.
Patients and Advocacy Groups: For patients, particularly those relying on BYLVAY, longer patent protections might delay the availability of more affordable generic versions. However, knowing the regulatory review process ensures the drug is safe and effective may offer reassurance.
In conclusion, while the document succeeds in conveying essential regulatory information, simplifying complex processes and clarifying outcomes could enhance comprehension for all stakeholders involved.
Issues
• The document could be clearer regarding the specific criteria for determining whether an applicant acted with due diligence during the regulatory review period.
• The process for submitting confidential and non-confidential comments and the distinctions between them might be unclear to some readers. Simplifying this explanation or providing a flowchart could help.
• The explanation of the regulatory review period and how it affects patent extension is technical; a simpler summary could make it more accessible to a broader audience.
• The document does not specify the result of the patent term extension application (whether the requested time extensions of 630 days, 679 days, or 861 days were justified or approved).
• It is not clear what the implications are if someone submits comments claiming the published dates are incorrect. The document should clarify the potential outcomes of such submissions.