Re: Feedback to FDA on Generic vs Brand Medication
Thank you for your message to the Center for Drug Evaluation and Research (CDER), one of the six centers within the Food and Drug Administration (FDA).
People can react differently to generics or different brands because the inactive ingredients can be different or there could be something wrong with a particular lot of the product. We recommend that people report any problems they are experiencing with generic drug products to our MedWatch program. This program is a voluntary system of reporting to FDA problems patients' experience with products we regulate. We view this reporting system as a source for signaling trends. Should a trend emerge, the FDA will work with the sponsor of the product to address the problem. Actions may include changes in the labeling information or product packaging, change in manufacturing processes, enhanced warnings in the labeling or communications to health care professionals. In the most serious cases or where other attempted actions have not been effective, the sponsor may decide to remove the drug from the market or the drug may be recalled.
We now have a way to report directly to MedWatch via the Internet. You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/medwatch/index.html), and then click on "Submit a Serious Medical Product Report Online". In addition, if you would like to report your adverse experience directly to the MedWatch Program, please call 1-800-FDA-1088. Alternatively, you can call our Office of Drug Information at 301-796-3400, and request that a MedWatch packet be sent to you. Please be sure to include as much information on the product, such as manufacturer, NDC number, lot number. If you cannot obtain any of this information, as an alternative, please provide the imprint code printed on the tablet/capsule.
Division of Drug Information
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our 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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