FDA Announces Two Initiatives to Support Generic Drug Competition

FDA Introduces Two Initiatives to Encourage Generic Drug Competition

On Monday, June 18th, FDA introduced two initiatives intended to increase access to generic drugs and promote generic competition. The Agency requested $37.6 million in fiscal year 2019 to fund these two initiatives.

Knowledge-aided Assessment & Structured Application

The first initiative will create the Knowledge-aided Assessment & Structured Application (KASA) platform. KASA is intended to improve the generic drug review process by switching from a text-based assessment to a data-based assessment. According to a recent blog post from the FDA, “the KASA will enable a structured review that will make the application review process more efficient, and allow deficiencies to be spotted earlier […] The new KASA system will help sponsors submit high-quality and more complete applications on the first submission. It will decrease the risk that applications will be refused for receipt and reduce the number of review cycles that applications undergo.” FDA expects that the new system will allow portions of the application to go through an automated review. This will save time, and allow FDA to provide earlier feedback, thus increasing the chance of first cycle approval.

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Generic Drug Labeling

The second initiative relates to generic drug labeling. Typically, generic drugs are required to have the same labeling as their branded reference drug, tasking the manufacturer of the branded product with following the Agency’s labeling requirements. As such, when brand companies stop updating their labeling, generic labeling also becomes out-of-date. One of the FDA’s main goals is to always make sure that doctors and patients have the most up-to-date information on drug products, and according to a recent statement from the Commissioner of the FDA, Scott Gottlieb, M.D.:

“Consistent with our current authorities, which allow for certain types of labeling changes to continue to be made for generic drugs after the brand drug is withdrawn, this budget request will provide the funding to allow the FDA to assume more responsibility to help bring these drug labels up to date.”

The Agency also stated that it intends to begin this initiative by updating generic cancer drug labels first.

Are you a generic drug manufacturer? Are you in the process of developing a generic drug? Whatever stage you are at, we can help with all FDA-related matters.  To learn more about our services and how we can help you, contact us today.