Gentlemen, We Can Rebuild the ANDA – Better, Stronger, Faster: FDA Issues Guidance on Quality ANDA Submissions

By Kurt R. Karst –      

Although this blogger didn’t catch the episodes of The Six Million Dollar Man that originally aired in the mid-1970s, I did see them once they were syndicated.   As I remember it, the opening theme and narration to the popular television show starring Lee Majors as Steve Austin was gripping – at least to a young child in the early 1980s.  (The same can be said for the opening theme and narration to The Incredible Hulk television series starring Bill Bixby as Dr. David Banner and Lou Ferrigno as the Hulk.)   The premise of The Six Million Dollar Man is that after a terrible crash, austronaut Steve Austin had to be rebuilt with bionic implants to assist a government organization fight crime (and even Bigfoot).  As the opening narration states:  “Steve Austin, astronaut.  A man barely alive.  Gentlemen, we can rebuild him.  We have the technology.  We have the capability to build the world’s first bionic man.  Steve Austin will be that man.  Better than he was before. Better, stronger, faster.”

The opening narration to The Six Million Dollar Man played on a mind loop while this blogger read FDA’s recent guidance offering to ANDA sponsors: “ANDA Submissions — Content and Format of Abbreviated New Drug Applications.”  The guidance, which is accompanied by a webcast providing an overview of the document, is part of a broader initiative by FDA and the Office of Generic Drugs (“OGD”) to rebuild the generic drug program in the U.S.  It also comes as folks gear up for the full implementation of the Generic Drug User Fee Amendments (“GDUFA”) later this year.  The draft guidance complements other OGD efforts aimed at improving ANDA quality, incuding guidance on enhanced refuse-to-receive standards, the establishment of a public docket (Docket No. FDA-2014-N-0032) to receive input and suggestions on ways to improve ANDA quality and on how to best communicate those suggestions to the generic drug industry (see our previous post here), and other offerings on OGD’s website.

The ANDA quality guidance doesn’t break any new ground.  Of course, that’s not what it is intended to do.  Rather, the value of the draft guidance is that it consolidates a lot (but not all) of OGD’s best advice and cross references to other policy documents on point in one organized document for easy reference and clarity.  As FDA states in the notice announcing the draft guidance:

The guidance document is intended to assist applicants in preparing complete and high-quality original [ANDAs] for submission to FDA under the [FDC Act].  The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions.  This guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information to be submitted in each section of the application.

The focus on quality is important if, in this post-GDUFA world, there are to be significant numbers of first-cycle approvals.  Under the GDUFA Performance Goals and Procedures, FDA agreed to review and act on 60% of original ANDA submissions within 15 months from the date of submission for the year 3 cohort (Fiscal Year 2015); 75% of original ANDA submissions within 15 months from the date of submission for the year 4 cohort (Fiscal Year 2016); and 90% of original ANDA submissions within 10 months from the date of submission for the year 5 cohort (Fiscal Year 2017).  Acting on an application includes issuance of a complete response letter, an approval letter, a tentative approval letter, or a refuse-to-receive action. 

Higher quality ANDAs should minimize the number of complete response letters and refuse-to-receive actions, and increase the number of tentative and final approvals.  Clearly, we’re not yet at that point.  According to the most recent GDUFA statistics published by FDA, the number of complete responses and refuse-to-receive actions significantly outnumber the number of tentative and final approvals.

We doubt that the generic drug industry will tolerate such statistics as we move deeper into GDUFA – and begin thinking about GDUFA II – however, we recognize that GDUFA is a two-way street.  FDA has to have a better, stronger, and faster generic drug program under GDUFA, but help make that happen, the generic drug industry needs to submit applications of the highest quality.