Current Law User Fee Increases
Why is this request necessary?
The budget request includes increases in current law user fees to implement statutorily prescribed fee increases as follows:
- $15,268,000 for Prescription Drug User Fee Act (PDUFA) fees.
- $3,426,000 for Medical Device User Fee Modernization Act (MDUFMA) fees.
- $286,000 for Animal Drug User Fee Act (ADUFA) fees.
- $349,000 for Mammography Quality Standards Act (MQSA).
- $661,000 for Drugs and Devices Export Certification.
- $180,000 for Color Certification User Fees.
How does this request support Executive Branch public health priorities?
The user fees FDA currently collects support the Executive Branch’s vision of transforming health care and improving access to FDA-regulated products through enhanced performance funded by user fees. This permits FDA to reduce the time it takes for safe and effective human and animal drugs, medical devices, and other FDA-regulated products to reach the market. The user fees supplement appropriated dollars and enabling programs to hire additional scientific review staff and review process managers, improve the review process, reduce review time, and provide essential information technology to support the review process.
What are the risks of not providing the request?
Without additional resources, FDA would not:
- Meet the performance commitments for faster medical device review (MDUFMA) and faster human drug (PDUFA) and animal drug review (ADUFA). The requested resources would help provide the public with earlier access to safe and effective medical products, thereby saving lives, relieving suffering, and improving the quality of life.
- Sustain patient access to safe and effective new products by providing rapid, transparent, and predictable review of marketing applications.
- Maximize safe and effective use of medical products by communicating benefits and risks more effectively.
- Prevent harm from regulated products by improving problem detection and minimizing the time between detection and appropriate risk management response.
- Increase availability of FDA experts to expand and improve consultation and outreach to industry, thereby reducing drug development time.
What activities will these funds support?
The Bioterrorism Act of 2002 reauthorized the collection of PDUFA user fees to enhance the review process of new human drugs and biological products, and established fees for applications, establishments and products. This authority is effective for five years and directs FDA to strengthen and improve the review and monitoring of drug safety. The law also requires FDA to expand interaction with sponsors during the review of drugs and biologics intended to treat serious and life-threatening diseases and develop principles for improving drug and biologic review.
Based on current information and established PDUFA formulas, the statute authorizes fee increases of $15,268,000 in FY 2007 to support drug review. This increase is based on inflation and workload factors associated with FDA’s drug review program.
The fees that the agency collects support the following FDA performance goals:
- Preventing harm from regulated products by improving problem detection and minimizing the time from detection to appropriate risk management action.
- Sustaining access to safe and effective new products by providing rapid, transparent, and predictable review of marketing applications.
- Preventing harm from regulated products by increasing the likelihood of detection and interception of substandard manufacturing processes and products, through efficient and effective risk-targeting, external partnering and collaboration.
Enacted in 2002, MDUFMA is patterned on the success of PDUFA, and is designed to improve the quality and timeliness of the medical device review process. It authorizes FDA to collect user fees to supplement the appropriated portion of the medical device review program. FDA collects fees from device manufacturers that submit premarket applications and premarket notifications.
Based on current information and established MDUFMA formulas, the statute authorizes fee increases of $3,426,000 in FY 2007 to support this program. This increase is based on inflation and workload factors for the device review program.
Fees collected support the following FDA performance goals:
- Increasing safe and effective use of approved medical products.
- Increasing access to safe and effective new medical products for unmet public health needs, including untreated conditions, emerging infectious diseases, and medical countermeasures, by increasing the number and quality of marketing applications.
- Maximizing medical product quality through improved manufacturing practices using new scientific and technical standards and systems.
ADUFA: + $286,000
Enacted in November 2003, ADUFA has improved the availability of safe and effective animal drugs. As a result, it allows food animal producers to maintain healthy animals with the assurance that food products derived from those animals will be safe, wholesome, and free of drug residue. Making safe and effective drugs accessible also ensures that companion, service animals that assist the disabled, and animals such as zoo animals will live healthier and longer lives.
Based on current information and established ADUFA formulas, the statute authorizes fee increases of $286,000 in FY 2007 to support this program. This increase is based on inflation and workload factors for the FDA animal drug review program.
Fees collected support the FDA performance goal of promoting safe and effective animal drug availability and ensuring public and animal health by meeting ADUFA performance goals.
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among American women. Experts estimate that one in eight women will contract breast cancer during their lifetime. MQSA, which Congress reauthorized in October 2004, addresses the public health need for safe and reliable mammography. MQSA required that FDA certify mammography facilities by October 1994, and inspected facilities annually to ensure compliance with national quality and safety standards.
The reauthorization codified existing certification practices for mammography facilities and laid the groundwork for further study of key issues that include ways to improve physicians’ ability to read mammograms and ways to recruit and retain skilled professionals to provide quality mammograms.
The statute authorizes FDA to collect fees to pay for the costs of the annual inspections. In FY 2007, FDA is requesting a $349,000 increase. This increase is based on inflation and workload factors for the medical device review program.
This program supports FDA’s strategic goal of reducing the risk of medical devices and radiation emitting products on the market by assuring product quality and correcting problems associated with their production and use.
Export Certification (Drugs/Devices): +$661,000
FDA is required to issue certificates to any person wishing to export a drug, animal drug, or device. These certificates state that the product meets certain requirements of law. This applies to products approved for sale in the U.S. as well as unapproved products. The purpose of these certificates is to promote the export of products made in the U.S. The $661,000 increase will cover program inflationary costs.
Color Certification: +$180,000
The Federal Food, Drug and Cosmetic Act (FFD&C) requires the certification of color additives. This function, which is administered by FDA's Center for Food Safety and Applied Nutrition, involves assessing the quality and safety of color additives used in foods, drugs and cosmetics. Employee salaries and expenses are funded directly by FDA's Revolving Fund for Certification and Other Services, which is financed entirely by fees paid by commercial organizations. The FY 2007 increase of $180,000 will cover the program inflationary costs and ensure that the program has adequate reserve funding.
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