FDA Launches Online Complaint Reporting Form

Because Agency’s Testing Doesn’t Catch Everything

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FDA Offers Online Problem Complaint Form. George Marks/Hulton Archives

The U.S. Food and Drug Administration (FDA) has launched a new on online form where consumers can report adverse physical reactions or other problems with products the agency regulates.

Using the FDA’s MedWatch form, consumers can report adverse events they have suffered, observed or suspect due to human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures.

Tbe MedWatch form can be used to submit reports and complaints for:

  • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient treatment centers;
     
  • Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products);
     
  • Medical devices (including in vitro diagnostic products);
     
  • Combination products;
  • Cosmetics; and
     
  • Foods and beverages (including reports of serious allergic reactions).

What Cannot Be Reported on MedWatch and Where to Report It

The MedWatch form cannot be used to report problems with:

  • Vaccines: Problems with vaccines should be reported via the Department of Health and Human Service’s (HHS) online Vaccine Adverse Event Reporting System (VAERS).
     
  • Dietary Supplements: Problems with dietary supplements should be reported via the HHS’ Safety Reporting Portal (SRP).
     
  • Veterinary Medicine Products: Problems with veterinary drugs and products should be reported as instructed by the FDA.
     
  • Illegal Internet sales of medical products: If you suspect a Web site is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics, report the site as instructed by the FDA.

    Cases of false or misleading advertising for any consumer product, including FDA-regulated products, should be reported to the Federal Trade Commission (FTC) via its online Complaint Assistant.

    Why Consumer Reports are Important to the FDA

    Let’s face it. The FDA is responsible for testing and approving lots of products before they can be sold to consumers.

    “FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled,” notes the FDA on its Web site. “It also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, veterinary drugs, animal feed, and electronic products that emit radiation, ensuring that these products are safe and effective.”

    Related: US Food Safety System

    While the FDA is often criticized for taking so long to test the products it regulates before approving them for sale, even its extensive testing fails to catch all problems. Some problems with FDA-approved products slip through testing and are only discovered when the products are used by a large number of people.

    As a result, the FDA depends heavily on consumers to report any adverse reactions or other problems with products it regulates. Reports from consumers, helps the FDA take prompt and appropriate action to ensure the public health.