The Prescription Drug User Fee Act (PDUFA) was signed into law in 1992 by George H. W. Bush, as an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA). This act required the FDA to collect certain types of user fees from the drug companies whose products it regulates and to use that money to fund the agency review and monitoring of those products. PDUFA is considered one of the most significant federal policies in support of American pharmaceutical innovation. It helps ensure that new drugs are safe and effective and that clinical trials are designed appropriately. It also allows FDA to have a strong and steady presence monitoring the development and manufacturing of new treatments.
The History of PDUFA
As noted, PDUFA was passed in 1992, establishing a fee-based system to help fund the FDA’s drug approval process. The idea was that by charging certain fees for filing certain types of submissions, the FDA would be better able to regulate and review drugs. Initially, only drug manufacturers were required to pay these fees, but in 1997, Congress expanded this requirement to also include biologics manufacturers.
PDUFA must be reauthorized every five years. It has consistently been reauthorized since its inception:
1992 – PDUFA
1997 – PDUFA II
2002 – PDUFA III
2007 – PDUFA IV
2012 – PDUFA V
2017 – PDUFA VI
2022 – PDUFA VII – reauthorizes the Act through September 2027
Benefits of PDUFA
PDUFA helps FDA keep up with the fluctuating number of drug submissions and maintain the appropriate resources to review new applications. PDUFA has allowed FDA to hire more qualified staff when needed. It has also facilitated internal agency projects that improve the review and approval process by leveraging technology, the implementation of standards, and best practices.
For industry organizations, the stable source of funding that PDUFA provides facilitates a more predictable and consistent process and timeline. This helps manufacturers plan and align internal efforts with agency actions. The additional pool of funded employees supports the FDA’s efforts to improve regulatory science and offers greater flexibility to respond to changing workloads and priorities. As one might imagine, the ability to prioritize time-sensitive projects will help address concerns about performance expectations set forth by Congress under PDUFA.
Under PDUFA, the FDA strives to meet certain timelines for various regulatory actions. These timelines are often referred to as the PDUFA dates. They refer to the date by which the agency aims to complete the review of a new application. For most applications, it is within ten months or within six months for products designated as priority reviews. The clock starts when an application is accepted. In some scenarios, the PDUFA date may be extended. If the sponsor submits a major amendment where new data is included for a clinical study report, the PDUFA date may change.
Exceptions to PDUFA Fees
There are a few exception cases where PDUFA fees are not applicable. An application fee is not required for the resubmission of an application if the fee for the original application was already paid, the application was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver).
Fees are not mandated for designated orphan drugs or indications. Designated orphan drugs are drugs that are intended to treat rare diseases, typically ones that affect fewer than 200,000 people in the United States. These drugs do not require fees for review by the FDA under the Prescription Drug User Fee Act (PDUFA). If you plan on submitting a pre-market approval application for a designated orphan drug or indication, be sure to include language describing why your product would not be available if the PDUFA fees were charged.
Finally, skin-test diagnostic products do not require a PDUFA fee. However, they still need to comply with other requirements in the Code of Federal Regulations (CFR).
If a company determines they are eligible for an exception, it must file a request online at FDA’s Public Submission website within 45 days of submitting the marketing application to the FDA.
What is in PDUFA VII?
The President signed the FDA User Fee Reauthorization Act of 2022 into law on September 30, 2022. This Act includes the reauthorization of the Prescription Drug User Fee Act that spans fiscal years 2023 through 2027. This amendment is known as PDUFA VII.
PDUFA VII continues the agency’s efforts toward two important goals. One, it seeks to increase the predictability of FDA review times for new drug applications (NDAs) and biologic licensing applications (BLAs) through congressional action. Two, PDUFA VII also seeks to provide additional flexibility for the FDA review of NDAs/BLAs. It documents increased transparency requirements for both the agency and sponsors.
It did so by requiring that all interactions between FDA reviewers and sponsors be recorded electronically from the moment an application is submitted until a decision is reached on whether or not to approve a drug or biologic product. Additionally, PDUFA VII requires that those reviews include time estimates and associated risks from the beginning of the review process. Reviewers must give notice to sponsors when there is no longer sufficient time to complete a pre-NDA meeting. A sponsor can then choose either to withdraw their application voluntarily or ask for a scientific conference with FDA if they believe there are unresolved issues preventing approval of their application within established timelines.
Current PDUFA Fees
PDUFA fees apply for human drug applications that require full clinical data to support safety and efficacy as well as applications where clinical data is not required. The fees are due when the applications are submitted.
The FDA will be adjusting PDUFA fees in 2023-2027 fiscal years. The table below shows the rate changes for various types of applications and the annual program fees.
Prescription drug program fees (program fees) are assessed annually for each eligible prescription drug product that is identified in a human drug application approved as of October 1 of the fiscal year. The annual fees are due on October 1 or the first business day after October 1. Applications submitted in prior years must have been successfully reviewed and approved or have passed a review cycle to be assessed a program fee.
For the last 30 years, the FDA has implemented and used PDUFA fees to strengthen its capabilities and capacity to support new drug and biologic application review and approval processes. During this time, we have seen the agency build on practical learnings and experiences to improve response times and communicate with sponsors more effectively. At the 30-year mark, we can expect more of the same as PDUFA VII continues the agency’s focus on efficiency, effectiveness, and transparency across the product review and approval process.
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