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The FDA keeps a database for adverse events (i.e. side effects, serious injuries, deaths) related to a particular pharmaceutical. Both doctors and patients have the option of voluntarily reporting problems to the agency or a drug manufacturer, but drug companies are required to investigate and report side effects that may be attributable to their products. Many drug makers are apparently filing patchy reports regarding side effects with the Food and Drug Administration (FDA), according to a new study published. 

This information is necessary for the FDA to track troubling trends with a particular pharmaceutical. Failing to disclose side effects not only comes with potential governmental sanctions, but not disclosing adverse events gives the impression that manufacturers are trying to hide side effects. It appears that pharmaceutical companies keep up with filing their reports, but this recent study shows they are filing incomplete reports.

Compared to side effect reports turned in by physicians and consumers, drug makers generally fail to include key data that the FDA might use to assess future warnings.  According to experts interviewed in this study, “with increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarked surveillance has major problems that are not being addressed.”

The analysis found that in 2014, the FDA received 58,192 new reports of a serious or fatal side effect, of which 4.7 percent were filed with the agency directly by doctors and consumers.Of those reported by physicians and patients, 86% included important data points such as the patient’s age, gender, date the side effect occurred and a medical term to describe the problem.  Of those reported by drug manufacturers, who filed 95.3% of reports, half were missing information.

Thomas Moore, a senior scientist at the Institute for Safe Medicine Practices, a nonprofit that tracks drug safety issues, suggested that the FDAs reporting system has not kept pace with changes in pharmaceutical marketing. Since the last upgrade to the system in in 2001,  the internet has played a much larger role in doctor-patient relationship and pharmaceutical marketing.

See some of my previous posts about pharmaceutical companies and the FDA, these can be found under the “FDA & Perscription Drugs” category on Lansing.legalexaminer.com.

 

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