By Matthew Bin Han Ong
President Barack Obama signed the FDA Safety and Innovation Act July 9—enabling the FDA to collect about $6.4 billion in user fees over the next five years and expedite drug review and development.
The new law includes the Prescription Drug User Fee Act, or PDUFA V—the fourth reauthorization of FDA’s user fee program. The Congressional Budget Office predicts FDA will collect $4.068 billion in prescription drug application fees over the next five fiscal years.
PDUFA V is projected to fund 2,599 full-time equivalent staff members who will work towards FDA’s commitment to review and act on 90 percent of standard applications within 10 to 12 months from the date of filing, and on 90 percent of priority submissions within six to eight months. By some estimates, this funding could help decrease the time it takes to review applications by 33 percent by the end of the program’s fifth year.
For the first time, the law allows FDA to collect fees for biologic and generic drugs, giving the agency resources to quickly review generic drug applications and fund the new approval pathway for biosimilar biologics created by the Affordable Care Act.
The generic user fees are expected to generate $1.575 billion, and the biosimilar fees will generate $128 million.
“The historic user fee legislation will provide FDA with additional resources and ensure all participants in the U.S. generic drug system, whether U.S.-based or foreign, comply with our country’s strict quality standards,” said Ralph Neas, president and CEO of Generic Pharmaceutical Association. “Very importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs.”
To help combat drug shortages, the law requires manufacturers of certain drugs to notify FDA when they experience circumstances that could lead to a potential drug shortage, said Kathleen Sebelius, secretary of the Department of Health and Human Services.
Oncologists have experienced a growing number of shortages of therapies the past two years, said Michael Link, immediate past president of the American Society of Clinical Oncology. The majority of these treatments are old, off-patent chemotherapy drugs, and the enactment of this law makes significant strides in addressing a crisis in public health and reduces the number of drug shortages, he said.
“While we are glad that the law requires drug manufacturers to notify the FDA six months in advance of an anticipated shortage, fines or similar penalties are needed to ensure that manufacturers comply,” Link said. “ASCO will continue to advocate for legislation adding this enforcement mechanism.”
Link also urged Sebelius to include biologics in the drug shortage provisions immediately, because biologics are already first-line treatments for numerous cancers.
“The pace and bipartisan fashion [in] which the House and Senate moved this legislation shows their keen understanding of the need for enhanced scientific capacity at the FDA, and the urgency that patients across the United States have for new lifesaving treatments for diseases like cancer,” said Ellen Sigal, chair of Friends of Cancer Research.
Other provisions include changing FDA’s inspection policy from a mandatory inspection of domestic plants every two years to inspections on both domestic and overseas manufacturing plants based on risk-to-patient safety. The law also reauthorized two pediatric drug measures set to expire this year and increased staffing for rare disease programs.
President Barack Obama signed the FDA Safety and Innovation Act July 9—enabling the FDA to collect about $6.4 billion in user fees over the next five years and expedite drug review and development.
The new law includes the Prescription Drug User Fee Act, or PDUFA V—the fourth reauthorization of FDA’s user fee program. The Congressional Budget Office predicts FDA will collect $4.068 billion in prescription drug application fees over the next five fiscal years.
PDUFA V is projected to fund 2,599 full-time equivalent staff members who will work towards FDA’s commitment to review and act on 90 percent of standard applications within 10 to 12 months from the date of filing, and on 90 percent of priority submissions within six to eight months. By some estimates, this funding could help decrease the time it takes to review applications by 33 percent by the end of the program’s fifth year.
For the first time, the law allows FDA to collect fees for biologic and generic drugs, giving the agency resources to quickly review generic drug applications and fund the new approval pathway for biosimilar biologics created by the Affordable Care Act.
The generic user fees are expected to generate $1.575 billion, and the biosimilar fees will generate $128 million.
“The historic user fee legislation will provide FDA with additional resources and ensure all participants in the U.S. generic drug system, whether U.S.-based or foreign, comply with our country’s strict quality standards,” said Ralph Neas, president and CEO of Generic Pharmaceutical Association. “Very importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs.”
To help combat drug shortages, the law requires manufacturers of certain drugs to notify FDA when they experience circumstances that could lead to a potential drug shortage, said Kathleen Sebelius, secretary of the Department of Health and Human Services.
Oncologists have experienced a growing number of shortages of therapies the past two years, said Michael Link, immediate past president of the American Society of Clinical Oncology. The majority of these treatments are old, off-patent chemotherapy drugs, and the enactment of this law makes significant strides in addressing a crisis in public health and reduces the number of drug shortages, he said.
“While we are glad that the law requires drug manufacturers to notify the FDA six months in advance of an anticipated shortage, fines or similar penalties are needed to ensure that manufacturers comply,” Link said. “ASCO will continue to advocate for legislation adding this enforcement mechanism.”
Link also urged Sebelius to include biologics in the drug shortage provisions immediately, because biologics are already first-line treatments for numerous cancers.
“The pace and bipartisan fashion [in] which the House and Senate moved this legislation shows their keen understanding of the need for enhanced scientific capacity at the FDA, and the urgency that patients across the United States have for new lifesaving treatments for diseases like cancer,” said Ellen Sigal, chair of Friends of Cancer Research.
Other provisions include changing FDA’s inspection policy from a mandatory inspection of domestic plants every two years to inspections on both domestic and overseas manufacturing plants based on risk-to-patient safety. The law also reauthorized two pediatric drug measures set to expire this year and increased staffing for rare disease programs.
