While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed. The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, how can the Agency rely on policy and administrative fiat to ignore those laws and regulations?
You may think, what is Pollock talking about? As Mezher points out, regarding the statutory requirements that both NDAs and ANDAs be reviewed in 180-days, “the agency has not routinely adhered to the 180-day review timeline established by the Kefauver-Harris Amendments [which by the way also apply to ANDAs] since before the 1992 Prescription Drug User Fee Act (PDUFA) [or for that matter GDUFA goal timelines]. FDA’s current new drug review program aims for a 10-month standard review and a six-month priority review for new drug applications (NDAs) on top of the 60-day window the agency has to file an application following its submission. For generic drugs, FDA aims for 10-month reviews for standard original abbreviated new drug applications (ANDAs) and 8-month reviews for certain priority original ANDAs.” For priority review NDAs, the 180-day limit is mostly achieved, but that’s it!
We all know there is a practicality between statute and regulation and the feasibility or capacity of the Agency to meet such timelines. But one would think, well, maybe the law and the regulations should be changed to reflect the reality of the capability of the FDA to meet its legal requirements!
Let us take this one step further when looking at statutory timeline requirements and an issue the Agency seems unwilling to even address. Section 505(j)(2)(C) of the Drug Price Competition and Patent Term Restoration Act, which deals with ANDA suitability petitions (see here for explanation of such petitions) requires that FDA either approve or deny these petitions within 90 days of receipt. Well, one might say FDA has not only missed the mark on these petitions but, perhaps over the last 5-10 years or longer, they have missed the planet! Few, if any, are acted upon at all today, let alone in 90 days. Many have been languishing for years. A few years ago, when scant actions on these petitions was occurring, our firm received an approval for a petition 7 years after submission and literally no action on suitability petitions have occurred over the last few years with very few (if any) exceptions.
Let me take you back to the one point, and for me, the meat, of Mezher’s post and the HHS’ recent actions. HHS is issuing a requirement not that FDA meet the requirements of the statute and regulations, but that the Agency be transparent in reporting yearly on by how much they fail to meet those statutory 180-day review requirements (see here) for each application they approve. But alas, my question still goes unanswered – how can the Agency avoid meeting its statutory and regulatory requirements by policy and administrative actions? Perhaps it is time to change the law and regulations to fit the circumstances of the times rather than have required timelines in the law and regs just be mere aspirations!