For those of you who have not yet read MaPP 5200.3 (here).   Responding to Industry Inquiries with Respect to Abbreviated New Drug Application in the Office of Generic Drugs, you better have your CEOs take a Valium prior to your reporting its contents.  In a nutshell, it says you can call us – but only the Regulatory Project Manager (RPM) and the call must be from your single designated industry contact, and we will tell you that the application is under review.  Simple eh!  Well, if you know the OGD response is going to be that your ANDA is under review, why call at all?  Is that what they want?  No calls at all?

I don’t want to repeat what my friend and colleague Kurt Karst of Hyman, Phelps, and McNamara law firm has already said in his FDA Law Blog post; you can read that here! But, I will say that Kurt’s points need to be read by all in the generic industry.

To reinforce what this MaPP means in terms of lack of useful information to the industry, let me tell you a brief story that actually just happened.  One of Lachman’s very senior regulatory team recently called the RPM (because she was instructed that she could no longer call the branch project manager) to check on the status of an ANDA that she has been working with OGD on for over 3 years.  After about 4 days, she finally made contact with the RPM and explained that she had recent information to lead her to believe that the ANDA was in the final clearance process for approval.  The RPM checked and told our designated contact that the application was under review and to call back in 6 months.  With information like that it seemed clear that the approval of the application might have been derailed and, obviously, this caused the firm a great deal of consternation.  The next day, however, the firm received the approval letter.  Well good news for the firm, but this is the kind of thing that drives CEOs, not to mention industry regulatory types, crazy.  First, the regulatory person at the firm had to deliver the news to senior management that was given to him, namely, that the firm should wait 6 months and call back OGD to find out the status of the ANDA (which would likely again only be that it is under review).  The CEO gets the news and halts efforts to launch the product after he fires the regulatory person bringing the message back from the RPM through our contact.  Well luckily, no one actually got fired in this instance, but it certainly makes a point relative to the quality and quantity of information that the OGD RPM is permitted to give out under this MaPP.

The goal of Hatch-Waxman is to bring high quality affordable generic medicines to the public.  Industry needs to obtain reasonable information in order to make informed decisions as to when to begin validation efforts (of course it is recognized that this effort is at risk), to order additional API for launch, to assure there are sufficient containerclosure systems available for packaging of launch material, and to take appropriate steps to get the product into the distribution system.  Bringing the product to market after approval cannot happen at the flip of a switch.  There is always a lead time, and gaining reasonable information about the status of an ANDA is key to assuring that the product when approved can get into the hands of the public as soon as possible.  Remember, the government is one of the largest purchasers of generic drugs through its Medicare, Medicaid, military, VA, and other Government contracting services.  Thus, it is the government that actually stands to save the most money.

One of the goals of GDUFA was to improve communication and transparency.  This MaPP now makes the status of ANDAs under review about as transparent as a brick wall.  One suggestion to help in the information gap may be for OGD to permit access to a listing of only ANDA numbers in the reviewers’ queues.  No drug names, no company names, and no reviewers’ names.  Since the firms will know their ANDA numbers, they will be able to see where their application is in the review process for each discipline and whether that review was completed.  At least that way, the firm could make some kind of an educated guess as to when they might expect some type of OGD action letter.

I don’t believe that the way this MaPP 5200.3 outlines OGD communication practices is exactly what the generic industry actually thought was part of GDUFA’s negotiated deal!