FDA Proposes That Adverse Event Reports Be Submitted Electronically

The Food and Drug Administration last week proposed new rules that would require adverse event reports related to approved devices, drugs and biologic products to be submitted electronically.  (Readers of MassTortDefense know how plaintiffs in mass tort litigation will attempt to use such reports to show the defendant company missed or ignored a "signal" of a safety issue with the product.)

When a drug or biological product is approved and enters the market, the product is introduced to a larger patient population in settings that may be different from clinical trials. New information generated during the post-marketing period can offer further insight into the benefits and risks of the product, and thus evaluation of this information is important to ensure the safe use of these products.

The FDA receives information regarding post-marketing adverse drug experiences from safety reports submitted to the agency. For nearly 35 years, FDA has received these post-marketing safety reports on paper. In recent years, some companies have voluntarily submitted these reports to
the agency in electronic format. Data from both electronic and paper reports are entered into FDA’s Adverse Event Reporting System (AERS) database. AERS is a computerized information database designed to support FDA’s post-marketing safety surveillance program for drug and biological products. The AERS database is used to store and analyze data received in post-marketing safety reports.

The FDA is proposing to amend its post-marketing safety reporting regulations to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the agency’s systems for collecting and analyzing post-marketing safety reports. The proposed change would help the agency, it believes, to more rapidly review post-marketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA’s public health mission. In addition, the proposed amendments would be a key element in harmonizing FDA’s post-marketing safety reporting regulations with international standards for the electronic submission of safety
information.

The FDA said the change will expedite the agency’s access to safety information and provide data to the agency in a format that would support more efficient and comprehensive reviews, and would enhance its ability to rapidly communicate information about suspected problems to health care
providers, consumers, applicants, and sponsors.

The agency says it is mindful of the security issues related to the confidentiality of data when safety
reports are submitted electronically, and will be prepared to respond promptly to changing
technology to ensure secure transmission of data.

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