Overview
Title
Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH
Agencies
ELI5 AI
The government checked how long it took to test and approve a medicine called VEOZAH, and they say it took a little over seven years. They're letting people know because there are some questions about how much extra time the medicine's special rules should last, and they want people to tell them if they agree or not.
Summary AI
The Food and Drug Administration (FDA) has calculated the regulatory review period for the human drug product VEOZAH, which is used to treat menopause-related symptoms. This review period consists of 2,573 days, split between the drug testing phase (2,248 days) and the approval phase (325 days). The announcement is necessary due to requests for patent term extensions filed with the U.S. Patent and Trademark Office. The FDA invites comments and petitions regarding the accuracy of these dates and the diligence of the applicant during the review process.
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VEOZAH 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
Summary
The document in question is an official notice from the Food and Drug Administration (FDA), detailing the determination of the regulatory review period for a drug called VEOZAH, which is used to treat menopause-related symptoms. The FDA has calculated a total review period of 2,573 days, which is split into a testing phase lasting 2,248 days and an approval phase lasting 325 days. This determination is a crucial step because it influences the potential extension of the drug's patent, which has been requested by the drug's patent holders. The FDA is soliciting feedback and petitions regarding the accuracy of this review period and the diligence of the applicant during this time.
Significant Issues or Concerns
Several issues stand out in the document. Firstly, the complexity of the language used may pose a barrier to understanding for those not familiar with legal or regulatory terminology. This includes references to specific sections of the Code of Federal Regulations (CFR), which may not be easily accessible to a general audience. Additionally, the process described for submitting confidential comments is quite complicated, involving multiple steps that could be daunting for contributors. The requirement to submit two copies of confidential submissions may also be seen as cumbersome.
Moreover, the document does not offer transparency regarding why the patent extension request is for specific lengths—616, 1,064, or 1,141 days. This lack of clarity might raise questions among stakeholders about the criteria or calculations involved. Lastly, the document does not explain why the total regulatory review period is exactly 2,573 days, which could concern those interested in whether this duration was fair or accurately assessed.
Impact on the Public
The impact of this document on the public is twofold. On a broad scale, it underscores the FDA's role in ensuring that drugs undergo rigorous testing and approval processes before being marketed. This process intends to safeguard public health by confirming that products like VEOZAH are safe and effective. On a more specific note, the determination of review periods influences the length of time a drug remains under patent protection, which can affect its price and availability. If patents are extended, it may delay the entry of generic alternatives, potentially impacting drug prices.
Impact on Specific Stakeholders
For pharmaceutical companies like Ogeda SA, the document is significant because it relates to potential patent extensions that can enhance the profitability and market exclusivity of their drugs. Longer patent protection helps to recuperate the costs invested in the drug's development and regulatory compliance. However, for generic drug manufacturers, extended patent periods may delay their ability to offer more affordable alternatives, affecting market competition.
Patients and healthcare providers might also feel the impact—either positively or negatively. If the patent extension leads to sustained high prices, it could limit accessibility for some patients. On the other hand, assuring that drugs like VEOZAH are thoroughly vetted can provide confidence in their safety and effectiveness.
In sum, while the document primarily addresses regulatory processes, its implications reach into areas that affect not just companies, but also consumers and the healthcare system at large.
Issues
• The document uses complex legal and regulatory language that might be difficult for a layperson to understand, such as specific references to various sections of the CFR (e.g., 21 CFR 10.20, 21 CFR 60.24).
• The process for submitting confidential comments is complex, involving multiple steps and specific instructions that might be challenging for some users.
• The requirement to submit two copies of confidential submissions might be seen as burdensome or inefficient for the commenter.
• There is no discussion or justification of why the requested patent term extensions are for specific numbers of days (616 days, 1,064 days, or 1,141 days), which could be seen as lacking transparency.
• Instructions for accessing the public docket and background documents could be clearer, as the procedure involves multiple steps and navigating different platforms.
• The document does not provide an explanation for why the regulatory review period was determined to be exactly 2,573 days, which might be of interest to those concerned about the duration's fairness or accuracy.