Electronic Communication OK For Product Recalls, FDA Says

Pharmaceutical firms may use email or other forms of electronic communication such as fax or text messaging to announce voluntary recalls or impart other important facts about drug safety to the public, the FDA said in a guidance released recently. In fact, the agency supports the practice.

The FDA said that dissemination of voluntary recall information, any necessary follow-up and the recipient acknowledgement and/or report to the recalling firm can all be done under the regulations by email or other electronic communication methods. If all attempts to follow up electronically fail, the manufacturer sending out the voluntary recall or safety information can always resort to other forms of communication.

Many Advantages Over Paper

The agency further noted that electronic communications have a number of advantages over paper-based communications, such as significantly shortening the lag time in informing the public, which is especially important when product safety is involved. Email and other electronic communications are also less costly and more efficient than other forms of communication, the agency noted, and receipt or delivery can be automatically verified.

Moreover, the guidance notes, email or other electronic communications are less likely to be discarded as junk mail than traditional first-class mail, since physicians’ offices, for example, are likely to have set up their email systems in advance to let communications from the pharmaceutical suppliers bypass “spam filters.”

Regarding formatting, the guidance provides somewhat more leeway than for traditional paper recall letters, since the “formatting and heading specifications for letters and envelopes in the current regulations … are generally inapplicable to email and electronic communications.” However, the agency recommends using some method such as marking an email message “URGENT” if it concerns a recall, and following other specifications as far as possible, for example including the envelope statements in the body of the email message or in a PDF attachment, and making the email or electronic communication “distinctive in appearance so that it will be promptly recognized and read” by appropriately flagging the subject line and including the name of the drug product affected.

Finally, the body of the communication should be concise and clear, and should identify the consequences if the information is not followed or if the product is used in the medical treatment of patients. The guidance can be accessed at http://www.fda.gov/oc/guidance/electronic.html. — Martin Gidron