While Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) and Dr. Kathleen Uhl, Acting Director, Office of Generic Drugs (OGD) are kicking around ideas about early communications of deficiencies and potential approvals to firms, the message that OGD is clamping down on phone calls and emails is being heard by Industry loud and clear. A (redacted) email (see below) back to a caller who left a voice mail indicated that centralized communication relative to certain status requests are being dealt with in a systematic manner. Such canned responses while taking the pressure off those who received such calls, provides little information for the firm (and Industry as a whole) regarding the original inquiry: .
Dear Sir/Madam:
The voice mail to XXXXXX of OGD on November xx, 2013, regarding the status of the meeting request submitted to the Office of Generic Drugs for drug ABC dated October yy, 2013, was forwarded to the Office of Generic Drugs email account for a response.
You should allow approximately 60 days for a response to be provided.
Please submit future control status request to the email below.
Email: GenericDrugs@FDA.HHS.Gov
Sincerely,
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
We have seen and heard similar responses to firms in the past that have sent emails to various OGD staff inquiring about various issues, indicating that most inquiries are being funneled into the OGD mail account for triage and response. Some of the emails have been converted into controlled correspondence when dealing with a policy issue or broader question other than request for ANDA status.
The uncertainty in the review process, created in part by the backlog and in part by the new FDA/OGD policy decisions either forced or required by GDUFA, has caused a paradigm shift relative to communications in OGD. The generic industry, as well as OGD, is on a steep learning curve regarding the new communication process and the lesson is hitting hard on the industry as information is critical for their planning.
Training is not always easy, but until all of the policy documents that are under development at OGD are issued, the Industry is learning by trial and error. Hopefully, we will begin to see a balance between the need to know and the ability to spend resources to provide the needed feedback as industry and OGD settle into the new paradigm.
