A broken FDA 'system' that must be fixed

The current US Food and Drug Administration system to announce hotly contested generic drug approval decisions is broken, say legal experts.

“As we see it, FDA’s “system” pleases no one and does not appear to be legally mandated,” commented Kurt Karst, John Fleder and Robert Dormer on US law firm Hyman, Phelps & McNamara’s FDA Law Blog.

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,” the lawyers examine two cases in particular – Hi-Tech Pharmacal Co Inc v United States Food and Drug Administration, No 08-01495 (JDB) and AstraZeneca Pharmaceuticals LP v. Burwell, No 16-cv-1336 (RDM) – where FDA's system to announce Abbreviated New Drug Application (ANDA) approval decisions has drawn fire from the judge presiding over the case.