The FDA's Front Door


It is pretty much common knowledge that if a medication or medical product causes a serious adverse effect within a medical environment, such as a hospital or nursing home, the medical establishment is required by federal law to report the incident to the FDA. However, there are many adverse events that are not being reported: Those that are experienced by the health consumer directly. What most people do not know, is that the patient or the patient's family and representative, can also directly report these adverse events to the FDA, without going through a physician, hospital or nursing home.

Before rushing off to report every bad side effect of a medication, it must first be understood what an adverse event is. In this case, in order to report it to the FDA there are criteria that must be met. These criteria are as follows:

  • Death
  • A life-threatening situation
  • Admission to a hospital or a longer than expected hospital stay
  • A permanent disability,
  • A birth defect
  • The need for medical or surgical care to prevent permanent damage

The FDA has a site that has the forms for a person to fill out reporting this incident and it can all be done through the convenience of the internet. There are a few qualifications in the instructions regarding this form and whether or not an incident is truly an incident, but there is a lot of room for interpretation on these "adverse effects". Interpretation that points out that what is an adverse effect to the patient may be an acceptable risk for the FDA. Perhaps that is how the problems with Rezulin and Lotronex occurred; different interpretations of what an acceptable risk is. This may be particularly true if a drug has been on the fast track for FDA approval in the past.

It would be important at this point to mention that vaccinations do not fall into this category. There is a separate form to report what is believed to be vaccination damage and that can be found at the VAERS (Vaccine Adverse Event Reporting System) site.

These are the definitions of serious adverse events as outlined above and defined by the FDA:

  • Death: Check ONLY if you suspect that the death was an OUTCOME of the adverse event, and include the date if known. DO NOT check if: a)The patient happened to die while using a medical product, but there was no suspected association between the death and the use of the product or b) A fetus is aborted because of a congenital anomaly, or is miscarried.
    • The copyright of the article The FDA's Front Door in Public Health Issues is owned by Adelle Vancil Tilton. Permission to republish The FDA's Front Door in print or online must be granted by the author in writing.

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