It is 2021 and the United States Congress will soon convene to discuss PDUFA reauthorization.
During this time the Commissioner of the FDA will go before members of Congress to explain how it can
help the Agency to continue fulfilling its mission. Assuming the FDA has properly met its review
timelines while collecting user fees from industry, compose a 2-3 page letter to the FDA Commissioner
stating why you believe PDUFA should, or should not, be reauthorized. If you believe PDUFA should be
renewed, describe any improvements you believe should be made to the previous Act. Remember, the
FDA has dual, sometimes opposing responsibilities to protect consumer safety while providing the public
access to potentially life-saving treatment. You may write the letter from the perspective of a consumer, a
Regulatory Specialist working in industry, or an FDA employee.
Background Information:
The Prescription Drug User Fee Act was initially authorized in 1992. In exchange for industry
user fees, the FDA agreed to follow deadlines imposed for drug review time among meeting other
performance standards. PDUFA was renewed in 1997, 2002, 2007, 2012, 2017. Over the past two
decades, annual user fees- which make up a large portion of FDA funding- have increased substantially as
the average drug review period has declined. However, debate continues whether PDUFA is directly
associated with the acceleration in NDA review times, and whether the decrease in average NDA review
time has compromised post-approval safety.
Prompt:
In a letter to the FDA Commissioner, describe the reasons you believe PDUFA should be amended,
kept the same, or ended. Provide evidence to support your argument. Consider average drug approval
times in recent years, post-approval safety problems, and the amount of user fees collected by FDA.
Several websites you may find useful include:
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There is no right or wrong answer. Evaluation will be based on justification of argument, clarity
of opinion, and proper citation and attribution of sources. PDUFA provisions aside from user fees and
review timelines may be used to support your argument.
Expert Solution Preview
Introduction:
The Prescription Drug User Fee Act (PDUFA) has been the topic of discussion in the United States Congress, with its reauthorization in question. As a medical professor responsible for evaluating student performance, it is important to analyze and understand the impacts of PDUFA on the healthcare industry. In this answer, we will explore the reasons for reauthorization or revision of PDUFA and provide evidence to support the argument.
Answer:
PDUFA has been instrumental in expediting drug reviews by the FDA, reducing the average drug review period to a considerable extent. The Act has allowed the FDA to collect user fees from industries, contributing a significant amount to its funding, and hence, improved its functioning. Moreover, PDUFA has undoubtedly acted as a catalyst in facilitating the development and availability of life-saving treatments to consumers.
However, with passing years and rising complexities of the healthcare industry, PDUFA has received scrutiny for reducing post-approval safety. In certain cases, drugs were found to pose severe health risks, leading to product recalls and other regulatory actions. It is imperative to review and revise PDUFA to address these concerns and maintain a balance between expediting the approval process and ensuring post-approval drug safety.
One of the improvements that could be made to PDUFA is an increase in the transparency of the approval process. By involving patient groups and healthcare experts, the FDA can scrutinize applications from a broader perspective, thereby ensuring public safety. Stricter regulations and requirements for post-approval studies, as a condition for drug approval, could also ensure compliance with safety regulations.
Moreover, PDUFA funding should be allocated for increasing the FDA’s capacity to monitor side effects and other safety concerns. By using the funds generated from the user fees to hire additional personnel for advanced data analytics and safety surveillance teams, the FDA can create a more robust post-approval safety monitoring system.
In conclusion, although PDUFA has been successful in reducing drug review periods and improving the FDA’s functioning, it has also raised valid safety concerns. It is important to revise PDUFA to maintain the balance between timely approvals and drug safety while enhancing transparency in the approval process. Therefore, PDUFA should be reauthorized, but with necessary modifications to ensure the safety of consumers while providing life-saving treatments.
