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Re: My letter to the FDA

Posted by detroitpistons on March 15, 2010, at 16:04:45

In reply to My letter to the FDA, posted by detroitpistons on March 12, 2010, at 15:10:48

Response from the general FDA/CDER mailbox:

Dear detroitpistons (not really),

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. I am sorry to learn of the problems you have tapering off Effexor.

As with any new drug the company would have to submit an application for a new drug approval for a tapering kit. The application would have to be supported by data from clinical trials. The FDA does not have the authority to require a firm to produce a product.

If you have not already done so, I would urge you to submit a MedWatch report.

You may submit your voluntary report via the following methods.

You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/Safety/MedWatch/default.htm), click on "Reporting Serious Problems to FDA", then "Reporting by Health Professionals" or "Reporting by Consumers".

In the Resources For You box on the left you can choose to:

1. Complete the voluntary form 3500 online.

2. Download a copy of the form and either fax it to us at 1-800-FDA-0178 or mail it back using the postage-paid addressed form.

If you are reporting a product problem with a generic drug product, please supply the NDC (National Drug Code) number. The NDC number on a product identifies the labeler/vendor, the product, and the trade package size. You can ask your pharmacist for this number. If you cannot obtain the NDC number, as an alternative, please provide the imprint code printed on your tablet/capsule. Product problems are quality, performance or safety concerns such as:

* Suspected counterfeit product
* Suspected contamination
* Questionable stability
* Defective components
* Poor packaging or labeling
* Therapeutic failures (product didn't work)

You will be personally contacted by an FDA staff member only if we need additional information. With the volume of reports on all issues, the Center does not have the resources to provide direct feedback to each reporter, or to confirm whether a report was received for a particular individual/incident or the status or outcome of a report.

The internet MedWatch on-line reports are acknowledged immediately via the internet and the reporter is able to print out a final copy of their report. This accounts for 60-70% of direct reports.

Mail and faxed reports with complete information, including a valid mailing address receive the MedWatch acknowledgement letter below if they provide a drug, an event, a patient and a reporter. This may take 2-3 weeks in processing.

Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. Reports submitted to MedWatch are added to a post marketing safety database and reviewed by the FDA's post marketing safety staff. One or two well-documented case reports may provide an early signal of unexpected safety issues and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day. We carefully evaluate and analyze all reports that were available to us and make recommendations for possible actions if the science based risk evaluation warrants the actions.
If the report contributed to the action, the labeling change and/or public advisory will reflect the action.

We rely on our website to offer new safety information on drug as a means to convey the results of investigations from MedWatch reports. Information about emerging safety signals is posted on the CDER Internet page at

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm, and MedWatch posts information on safety-related labeling changes at http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm.

Best Regards,
BD

Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.


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poster:detroitpistons thread:939283
URL: http://www.dr-bob.org/babble/20100305/msgs/939649.html