04 Nov
04Nov

High prices for prescription drugs, which in 2017 accounted for approximately 17% of total personal U.S. health care services, remain a major public health concern, and expenditures are projected to grow significantly through 2022 due to expensive new brand-name products. Fortunately, generic drugs are estimated to have saved around $1.7 trillion in U.S. health care costs over the last decade, but many brand-name drug products do not face generic competition.

Increasing generic drug competition can help patients to have access to more affordable therapies, which is a critical part of the CDER mission. CDER investigations identify drug and regulatory characteristics that appear to facilitate generic drug development.

To identify measures that might accelerate the development of generic drug products, CDER researchers recently investigated factors that might predict the likelihood that an abbreviated new drug application (ANDA), relying on a given reference (approved) drug product, would be submitted to the FDA. The investigators compiled proprietary data related to ANDA and other internal or public information maintained by FDA, as well as published information on drug sales, to learn whether a drug’s characteristics, or factors related to its regulatory history or market sales were predictive of an ANDA submission.

The CDER investigators found that the timely development of PSGs, including those for complex generics, along with prioritizing complex generic drug research, may facilitate ANDA submissions and promote drug price competition. FDA’s Office of Generic Drugs will continue to communicate best practices and clear recommendations before NCE drugs become eligible for generic competition to help ensure timely ANDA submissions and thus increase generic drug price competition. Increasing generic drug competition may in turn help patients to have access to more affordable therapies, which is a critical part of the CDER mission.


Source : USFDA

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