Regulatory Affairs

I was asked by a reporter how the Office of Generic Drugs (OGD) and FDA were going to respond to the overwhelming number of abbreviated new drug applications (ANDAs) that have been submitted not only in June of this year, but to the record numbers of ANDA submissions in since 2012.

The Office of Generic Drugs (OGD) confirmed today that the rush to get ANDA applications into the Agency before the new stability requirements go into effect on June 20, 2014 flew past all estimates and landed at just under 600 (the unofficial count is 598). OGD was shocked by the number of submissions with many there predicting a figure around 350. The rush was certainly on with a total of about 370 ANDAs submitted in the last 4 business days leading up to the June 20 deadline. One positive comment from OGD was at least we know the Electronic Gateway can handle the volume!

The Generic Pharmaceutical Association (GPhA) commissioned a survey organization (PublicMind) to poll physicians, physician assistants and pharmacists about how much they knew about the proposed generic drug labeling rule, how it would impact their practice (if at all), and how they felt about the current system of how generic drug labeling is approved by the FDA. The survey had some interesting results, which are summarized below.

Looking more typical of a December number of ANDA submissions, the May 2014 number of 134 is just a blip before (what we believe will be) a very big June. Remember that firms will be hustling to get ANDAs in before the new stability requirements go into effect on June 20, 2014.

With the approval of only 20 ANDAs in May (information derived from the CDER application approvals report), a statistic that is sure to give CEOs heartburn, the industry may start to question the GDUFA goals, unless many more ANDAs are driven to approval. As I have written before, Complete Response Letters (CRL) are the measure of GDUFA success based on the GDUFA metrics, but you can’t market products that receive Complete Response Letters. If I am not mistaken, the 20 monthly approvals are perhaps the lowest since the generic drug scandal back in the late 1980s and early 1990s.

In the Federal Register (FR) Pre-Publication listing this morning, FDA is announcing the issuance of a Draft Guidance entitled, Abbreviated New Drug Applications: Content and Format of Abbreviated New Drug Applications. The FDA says in the FR notice that “[I]n an effort to increase the number of original ANDAs that the Agency can receive upon initial submission and to decrease the number of review cycles required to approve an application for marketing, FDA prepared this Guidance on improving the quality of original ANDA submissions. FDA is committed to providing comprehensive assistance in the early stages of the application process to ensure that an original ANDA contains all information necessary for FDA to complete its review in one review cycle.“

In the first two years of GDUFA, the Office of Generic Drugs (OGD) DMF review team has been hard at work clearing up the backlog of DMF reviews and trying to figure out how to stay ahead of the game once the GDUFA metrics kick in in 2015. OGD did not want to penalize GDUFA submissions based on DMF submissions too severely because the DMF review process was so dramatically impacted and adjusted once GDUFA went into effect. So for years 1 and 2 of GDUFA, OGD exercised some regulatory flexibility in establishing a workable system. Now OGD has some advice for ANDA applicants that must be incorporated into your development and submission plans before your application is submitted.