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U.S. Department of Health and Human Services


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1. What FDA sought comment on:

Whether FDA's MedWatch system should be used as a tool to receive and disseminate timely information about counterfeit drug products, especially identification of suspect drug product? 

2. What the Comments Said:

Most of the comments supported the use of MedWatch for reporting suspect counterfeit drugs. These comments stated that health professionals are familiar with MedWatch and it would be too cumbersome and expensive to develop a new system, which people would have to be educated to use. One comment believed that reports of possible counterfeiting should be separate from MedWatch because it is not designed for criminal activity reporting and oversight. Another comment stated that because MedWatch is a voluntary reporting system, there could be significant under-reporting.

3. Discussion:

For nearly ten years, MedWatch has been FDA's reporting portal for adverse drug reactions and 'product problems.' These include problems with product quality that may occur during manufacturing, shipping, or storage, such as product contamination, defective components, poor packaging or product mix-up, questionable stability, and labeling concerns. If a pharmacist or consumer notices an unexplained change in size, shape, color, or taste of their dosage form, or notices that the coating is chipped or tablets are cracked, or that the drug is not working like it usually does, they may consider that to be a problem with their product. These are also characteristics that could occur if the product was a counterfeit drug. In fact, in the past, FDA has received some reports of suspect counterfeit drugs through MedWatch.

If a consumer suspects that his or her medicine is counterfeit, they are encouraged to contact the pharmacist who dispensed the drug, rather than report directly to MedWatch. The pharmacist may have information from the manufacturer that the shape, color, or taste of the product may have changed, or other information that may be helpful in determining if the product may be counterfeit or if the suspicious characteristic of the product or its packaging is expected.

The use of MedWatch is for health professional reporting. This would not affect the agreement with the Pharmaceutical Research and Manufacturers of America (PhRMA), whereby manufacturers have agreed to report counterfeits of their products to FDA's Office of Criminal Investigations, within 5 days of becoming aware of the counterfeit.

FDA has streamlined procedures for processing reports of suspect counterfeit drugs. The MedWatch Central Triage Unit (CTU) standard operating procedures (SOPs) have been amended to include "suspect counterfeit product" as a category of reports, so the CTU will know where to send the report for expedited processing.

It is easy and convenient to file a report with MedWatch. All reports are confidential and the identity of the reporter is not disclosed. FDA encourages reporting using the online reporting form that can be found at http://www.fda.gov/Safety/MedWatch/default.htm.

4. FDA Conclusion:

FDA plans to encourage and educate health professionals to report suspect counterfeit drugs to MedWatch.

  • FDA plans to encourage and educate health professionals to report suspect counterfeit drugs to MedWatch as an overarching mechanism to report such information;
  • FDA plans to change the instructions for the MedWatch reporting form, both paper and online versions, so reporters will know how and when to report suspect counterfeits. Additionally, FDA plans to amend the MedWatch website description of product problems to include suspect counterfeits.


Graphic on MedWatch Advice About Voluntary Reporting linked to long description