The Government shutdown is on everyone’s minds, but, as always, things happen that many of us in the general public don’t think of right off the bat to keep the title’s metaphor going. The shutout comes for any fee-paying application, supplement, device or other FDA regulated product that industry attempted to submit to FDA on or after October 1, 2013. Unless specific legislation is passed (continuing resolution or a budget) for FDA, the Agency is prohibited from collecting user fees for any product submitted in fiscal year 2014. Because the current statutes precludes FDA acceptance of new application unless the user fee is paid, well, you can see the “catch-22” that this construction presents.
So not so bad, eh, what’s a few days or weeks to wait to submit an application, since everyone is in the same situation? Well, if the application is for a life saving medication for which there is no current available treatment and you are the patient with the ailment, the few days or weeks might make a life or death difference.
Here is an example of an issue that arises now for abbreviated new drug applications (ANDA) that was never a concern before the government shutdown. Take an ANDA for a first time generic, where there is either a new patent listed for a drug with or without New Chemical Entity (NCE) exclusivity (the NCE example would apply to an NCE-1 or the newly issued patent during the 5th year after approval of the original new drug application). The ANDA applicants’ goal to be first-to-file to secure a 180-day exclusivity period during this shutout is thrown into chaos. If an NCE-1 or new patent listing occurs after October 1, 2014 and an applicant is trying to be first-to-file with a newly submitted ANDA, then they must resort to submission of the application every day until the budget issue is resolved. The uncertainty that this creates will certainly send CEOs directly to their medicine cabinet to take their heartburn medication.
What if I am an ANDA applicant that needs to submit a Prior Approval Supplement (PAS) to change my label to include a significant new warning that was recently added and approved for inclusion in the reference listed drug product’s label? My supplement can’t be received because my PAS is a fee-paying supplement. What does my delay in getting the warning into my label do for the health of the American public? How can the delay impact my liability? These questions will only be answered by a court if an ANDA holder is sued and finds themselves in this unenviable position.
The one good thing that comes out of this shutout is that it gives the Office of Generic Drugs (OGD) a slight breather, in that they can receive no new applications until this budget issue is resolved. With the likely large number of submissions in September who were trying to beat the new higher GDUFA fees that went into effect on October 1, 2013, OGD can begin to gain a foothold on getting those reviewed for receipt; the delay will give other OGD disciplines more time to spend reviewing ANDAs in the backlog of work OGD has before it. Unfortunately, this respite will be short lived as the new wave of applications and Prior Approval Supplements will begin pouring in as soon as the deadlock in Washington is resolved and Congress takes the needed action.
Politics and medicine really don’t mix. Perhaps we need to get some pitch hitters into the game to resolve this issue because the managers don’t seem able to play well together on the same field.