FDA report highlights savings from 2017 approvals
The Food and Drug Administration has released a report focusing on the savings that generic approvals brought the healthcare system in 2017. The report is the first of its kind from the FDA’s Office of Generic Drugs, and notes that the FDA fully approved 843 Abbreviated New Drug Applications, issuing tentative approval to a further 184 ANDAs.
The agency’s report estimates that savings from 2017 approvals through February 2018 totaled $11.8 billion, with $8.8 billion in savings through December 2017. Further, the report estimates that in one full year after each generic approval from last year, the savings will be $16 billion.
To reach its estimates, the FDA created a dataset using the 2017 ANDA approvals in the FDA’s Orange book, the NDC numbers of the approvals from various sources, a defined market parameter and monthly sales of all products with the same ingredients/route/dosage form as the 2017 approvals, including the branded drug and previously approved ANDAs. The agency noted that the sales data it looked at did not reflect rebates, discounts or off-invoice adjustments and that it measured market impact following approval rather than marketing. It also did not look at the impact of tentatively approved drugs because of delays that occur before full approval and exclusivity issues.
“FDA approved a record number of generic drug applications in 2017,” the report says. “Since its inception in 1984, the generic drug approval pathway has played a critical role in increasing access to safe, high-quality, and affordable medicines for the American public.”
The agency’s report estimates that savings from 2017 approvals through February 2018 totaled $11.8 billion, with $8.8 billion in savings through December 2017. Further, the report estimates that in one full year after each generic approval from last year, the savings will be $16 billion.
To reach its estimates, the FDA created a dataset using the 2017 ANDA approvals in the FDA’s Orange book, the NDC numbers of the approvals from various sources, a defined market parameter and monthly sales of all products with the same ingredients/route/dosage form as the 2017 approvals, including the branded drug and previously approved ANDAs. The agency noted that the sales data it looked at did not reflect rebates, discounts or off-invoice adjustments and that it measured market impact following approval rather than marketing. It also did not look at the impact of tentatively approved drugs because of delays that occur before full approval and exclusivity issues.
“FDA approved a record number of generic drug applications in 2017,” the report says. “Since its inception in 1984, the generic drug approval pathway has played a critical role in increasing access to safe, high-quality, and affordable medicines for the American public.”