Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.

People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.

Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

Justices acknowledged that the release of the Sackler family from civil liability is a boon for them but appeared averse to rejecting a plan that is supported by the vast majority of victims of the opioid crisis.

Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the agency’s policy for using background music in direct-to-consumer advertising, and the FDA’s new incoming principal deputy commissioner.

People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.