Drug Companies Do Not Adequately Report Side Effects to FDA

Posted by Sarah Showard | Mar 02, 2016 | 0 Comments

According to an analysis published in PDS, Pharmacoepidemiology and Drug Safety, most drug manufacturers are guilty of under reporting serious side effects of drugs on the market. Drug companies are required to investigate and report side effects of their products, however they often fail to report or file incomplete reports which makes it difficult to assess future warnings.  

The FDA maintains the Adverse Event Reporting System, a database for collecting side effect data.  Doctors and consumers can report problems to the agency or the drug company.  Compared to the reports filed by physicians and consumers, the drug companies generally fail to include key data necessary to assess appropriate warnings.  Thomas Moore, a senior scientist at the institute of Safe Medicine Practices, a nonprofit that tracks drug safety issues, stated “With increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarket surveillance has major problems that are not being addressed.”

 According to the analysis, of the 528,192 new reports of serious or fatal side effects received by the FDA in 2014, 4.7% were filed directly by doctors and consumers.  Of those, 86 % included complete information.  Of the 95.3 % filed by drug companies, however most were incomplete.  Reports involving patient deaths offered the least amount of information.  This is troubling as without this important information it is impossible to adequately assess the safety of these medications. 

 Showard Law Firm is Tucson's local law firm for defective drug and medical device claims.  If you believe you or a loved one have been harmed by a medication contact us for a free consultation.

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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Sarah and Peter are the proud chairs of this year's Heart and Stroke Ball, held on 2/17/18 at the El Conquistador. With a western theme "Heart of the West", this important fund raiser is in its 60th year, all raising funds to help with research and advances in the case against heart disease in the Tucson community.