The Rollout: FDA’s Mission Critical ANDA Undertaking

By Kurt R. Karst –       

A couple of weeks ago we announced a massive and unprecedented undertaking by FDA’s Office of Generic Drugs (“OGD”) to address an outpouring of concern about, among other things, a Manual of Policies and Procedures (“MAPP”) – MAPP 5200.3 – titled “Responding to Industry Inquiries with respect to Abbreviated New Drug Applications in the Office of Generic Drugs” that FDA published in September 2013 and that was criticized as restricting communication between OGD and ANDA sponsors concerning pending applications.  The fruits of OGD’s undertaking are beginning to rollout, and ANDA sponsors should expect to begin receiving correspondence from the Office. 

What will that correspondence look like?  Below is a representative letter from OGD (with fictitious products) detailing the status of various application components.   Applicants may receive multiple communications based on the number of ANDAs pending in OGD.  OGD emphasizes in the letter that “[t]his is a one-time communication intended to assist [applicants] to ascertain the current status of submissions.”  And while ANDA sponsors will certainly be tempted to contact OGD for further information – because in some cases the correspondence may raise more questions than provide answers – OGD says they should not do so: “Please do not respond to this communication by asking FDA or your Regulatory Project Manager for additional or more detailed information. . . .  It is not feasible for us to respond to a high volume of follow up inquiries.”  

DATE: February 12, 2014

TO: Generic Drugs, Inc.

ATTN: Responsible Company Official

E-Mail:

FAX:

RE: Update summary of filed and pending original ANDA(s)

Dear Sir or Madam:

The Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research, Food and Drug Administration (FDA), is providing you with this one-time communication on the status of your filed and pending original abbreviated new drug application(s) (ANDA) submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act. OGD is providing these updates as an interim measure to help applicants assess the status of their current submissions as we transition towards predictable goal times pursuant to the Generic Drug User Fee Amendments of 2012 (GDUFA).

Your status update is limited to available review information as of January 29, 2014. Any additional information regarding your ANDA collected after this date is neither considered nor provided. Furthermore, your ANDA status is subsequently subject to revision pending additional information or concerns raised by any of the discipline reviews (bioequivalence, clinical, chemistry, microbiology, labeling, facility), other unforeseen legal, scientific or regulatory issues, or inspectional results, which can also impact the status or ability to issue a complete response. Any applicable fees can also affect the status of your ANDA.

OGD is providing your ANDA status update in the attached chart with a list of applicable acronyms. The chart only contains current information regarding discipline review and does not forecast if and when OGD will issue a complete response, tentative approval, or final approval letter.

Please do not respond to this communication by asking FDA or your Regulatory Project Manager for additional or more detailed information. This is a one-time communication intended to assist you to ascertain the current status of submissions. It is not feasible for us to respond to a high volume of follow up inquiries.

Sincerely yours,

CAPT Aaron W. Sigler, USPHS
Chief, Review Support Branch

CHART ACRONYMS

Column Headings

ANDA - The application number for your Abbreviated New Drug Application
DRUG NAME - The official filed name of the drug associated with the ANDA number
CHEM - Product Quality Chemistry Review
BIO - Bioequivalence Review, typically including OSI, if applicable
MICRO - Microbiology Review
LABEL - Labeling Review
CLINICAL - Clinical Review
FACILITY – Overall Facility inspections summary. All facilities must be acceptable at the time of 29 JAN 14 in order to warrant an adequate notation. If one of more facility is not acceptable then the FACILITY column will be marked as such. OSI information is not considered.

Discipline Notations

IQ – Inadequate. This particular discipline is currently found to be inadequate.

AQ - Adequate. This particular discipline was found to be adequate when the information was gathered for this communication.

UR - Under Review. This particular discipline is currently assigned OR under review with the discipline team.

NR – Not Reviewed. This particular discipline is either currently not under review or assigned.

NA – Not applicable. This particular discipline is not required for the approval of this ANDA.

Facility Notations

PN – Pending, i.e., one or more facilities have been inspected and are pending an outcome.

AC - All facilities are acceptable at the time of this publication.

*Please note that you may receive your updates in multiple communications over time, based on the number of ANDAs pending in OGD.