FDA pledges to move quickly against companies that mass-market “illegal copycat drugs” by portraying them as equivalent to agency-approved medicines, commissioner Marty Makary says in a social media post, presumably signaling a tougher enforcement posture against compounded products like GLP-1 drugs for obesity.
A new spending package enacted this week includes two long-sought policy changes for FDA — clarifying the scope of orphan drug exclusivity and easing long-standing regulatory hurdles for generic drug developers.
