FDA to Begin Updating Generic Cancer Drug Labels With New Congressional Funding

Regulatory NewsRegulatory News | 18 June 2018 |  By 

The US Food and Drug Administration (FDA) on Monday announced it would use new budget funding to update generic drug labels and will begin with cancer drugs, among other initiatives.

In a blog post on Monday, FDA Commissioner Scott Gottlieb said the agency would use $37.6 million to fund two new initiatives: 1) to create a new review platform — known as the Knowledge-aided Assessment & Structured Application (KASA) platform — to modernize generic drug review from a text-based to a data-based assessment; and 2) to update the labeling of generic drugs.

“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which allow for certain types of labeling changes to continue to be made for generic drugs after the brand drug is withdrawn, this budget request will provide the funding to allow the FDA to assume more responsibility to help bring these drug labels up to date. We intend to launch this initiative initially for oncology products,” Gottlieb wrote.

Generic drug labeling changes have been the focus of recent court rulings, including one from March that said Merck can be sued for recklessness in failing to update the labels of generic versions of its brand-name drugs.

He also said KASA will allow FDA to provide earlier feedback to generic drugmakers as a way of helping to reduce multiple cycles of application reviews. FDA in January also targeted multiple cycle reviews with new draft guidance.


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