How FDA Announces Drug Approval Decisions: A Broken FDA “System” That Must Be Fixed

By Kurt R. Karst, John R. Fleder & Robert A. Dormer –

The current FDA system to announce hotly contested generic drug approval decisions is broken.  As we see it, FDA’s “system” pleases no one and does not appear to be legally mandated.  Moreover, whatever advantage FDA may think the Agency is getting from hiding the ball from the world on the timing and substance of these decisions is more than overcome by the criticism the Agency has received from judges.  In a new paper, titled “How FDA Announces Drug Approval Decisions: A Broken FDA ‘System’ That Must BE Fixed,” we examine two cases in particular – Hi-Tech Pharmacal Co., Inc., v. United States Food and Drug Administration, No. 08-01495 (JDB) (here) and AstraZeneca Pharmaceuticals LP v. Burwell, No. 16-cv-1336 (RDM) (here) – where FDA’s system to announce ANDA approval decisions has drawn fire from the judge presiding over the case.

FDA’s approval system for handling certain high profile ANDA approval decisions must be fixed. As we note in the paper, there certainly appears to be ample authority conferred on FDA to make changes without the need for additional legislation to be enacted. But if legislation is needed, then we call on FDA to spearhead a legislative fix. Congressional oversight committees may be a sound vehicle to compel FDA to focus on this problem. Perhaps the Department of Health and Human Services may be able to force FDA to change its ways. FDA needs to involve interested stakeholders in this process. We also urge FDA to communicate with the courts to try to get judicial input.