USA – FDA explains when it will rescind breakthrough designations

The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its evaluation of a drug.

While FDA has long asserted its authority to rescind or withdraw BTDs, the new guidance will add clarity for sponsors as to when the agency might revoke the designation. Since designation was created under the Food and Drug Administration Safety and Innovation Act in 2012, the agency has only rescinded BTDs from products about 35 times, according to the most current quarterly data available. The designation has been withdrawn after granting around 11 times. (RELATED: FDA rescinds two breakthrough therapy designationsRegulatory Focus 8 March 2019)

“The information supporting the granting of BTD for a particular drug may change over time. Some drugs that appear promising in early development may not be shown to be safe or effective in later trials, or the magnitude of a treatment effect suggested by early development may not be observed in later stages of development,” FDA explains in the guidance…