Reporting Adverse Events to the FDA Resumes After COVID Hiatus

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In the first half of 2020, the least amount of adverse events — also known as side effects — were reported in the last seven years.

The slowdown in adverse event reporting can be attributed to an official regulatory pause for a period of two months, beginning after March 31 until June 10, 2020.

Adverse event reporting is the most powerful tool used by the U.S. Food and Drug Administration to revise or remove defective and dangerous products, and it has been on an upward trend since 2013.

For the past few years, until now, the number of reports has reached more than 1 million annually. Will the reporting delay make a difference?

About Adverse Event Reporting

The FDA has two major databases for the collection of adverse events.

The database that deals with drugs, supplements, foods and homeopathic remedies is known as the FDA Adverse Events Reporting System Database (FAERS).

On the other hand, the Manufacturer and User Facility Device Experience Database (MAUDE) is devoted solely to reporting the side effects of medical devices.

FAERS and MAUDE are the basis for many of the FDA’s preliminary findings regarding a negative health outcome associated with a product. Each system is used to collect vital safety information, which may later become the basis for a black box warning or a full-fledged recall.

“The FDA doesn’t know what they don’t know,” Maria Gmitro, president of the Breast Implant Safety Alliance, told more than 40 viewers during MedTruth’s first live event on adverse event reporting.

A majority of adverse event reports come from manufacturers and physicians. The live event, which took place on June 17, intended to help patients learn how the FAERS and MAUDE adverse event reporting systems work.

A Decrease in Adverse Event Reporting

In 2019, patients and medical professionals submitted 2,191,808 reports to the FDA. By comparison, as of June 18, 2020, only 565,834 reports have been submitted this year.

A potential cause for the observed drop in reports may be COVID-19, as Madris Tomes, CEO and Founder of Device Events and former FDA employee, told MedTruth in an email.

“The FDA gave a short reprieve to manufacturers for reporting adverse events during the early weeks of the COVID outbreak,” Tomes wrote.

Tomes explained that this reprieve was intended to allow providers to prioritize the treatment of patients and avoid hospital visitation that is sometimes necessary for manufacturers to inspect or return a device.

While there have been records of the FDA relaxing reporting timelines and deadlines, as was suggested in 2017 during congressional negotiations with the agency, there have not been many recorded occasions that the FDA has paused reporting altogether.

Tomes also noted the reprieve could have been abused by some manufacturers.

“The problem came when the manufacturers of COVID tests and ventilators used that leeway to not report the issues with their devices,” Tomes wrote. “This delayed the FDA’s ability to get information on devices that weren’t working.”

Another proposed reason for the reduction of reports may be related to standard delays. In most states imposing a stay-at-home order, elective surgeries were restricted.

Tomes wrote, after reports were released on June 10, “I don’t see a spike in the number of reports because the backlog was likely off-set by the decrease in elective surgeries.”

The six-month period has introduced a variety of new COVID-19 treatments, testing kits and the increased production of ventilators by companies not traditionally producing them, making adverse event reports more central than ever.

Whether malicious or not, whether dangerous or irritating, the best way to ensure dangerous or faulty devices and drugs don’t remain on the market is to file an adverse event report after experiencing an unexpected side effect.

Download our guide to adverse event reporting to learn how to inform the FDA, manufacturers and patients about potential risks of drugs and devices.

Download Here

By James Parker

James Parker is a news writer and fact-checker from Coral Springs, Florida. He majored in Communication and Media Studies at Stetson University, where he spent much of his time examining the role of optics in various fields. When not covering the latest medical or legal development, James works on personal writing projects and board game design.

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