FDA issued two new proposed rules this week that would require all manufacturers to report adverse events electronically. The idea seems perfectly reasonable—every company uses computers and the Internet these days. But what struck me as odd is that the agency is still entering adverse event reports manually and that paper filings are still being used at all. As an editor, I spend a good portion of my day typing, but I haven’t had to retype or transcribe from a hard copy in years. It’s no wonder FDA has such a backlog of paperwork and lengthy review times. The growing global industry demands fast, electronic communication, and the agency must keep up with the culture. Before they know it, pharma companies will be sending adverse event reports or supply-chain breaches via Twitter—surely 140 characters is enough to note that a patient experienced a negative effect after taking a certain drug product.

I have to point out that FDA does accept electronic submissions for ANDAs, drug master files, and other filings [see their electronic submission list]. They even have a platform for electronic adverse event reports, which demonstrates that the agency has the technical know-how and capacity to go 100% digital. And in June, FDA issued guidance that drug establishment registrations and drug listings be submitted in electronic format only, with paper filings to be accepted only with a waiver, but a final rule making this a requirement has yet to be set.

For the sake of time—and the employees at FDA—I hope these proposed rules for adverse event filings are finalized quickly and that the agency—and industry—can let go of paper submissions once and for all.

ICH got on board with the electronic age in November 2003 when it finalized the electronic specs that applicants can use when submitting filings to regulators in various regions around the world. Known as the electronic Common Technical Document, or eCTD, submissions in this format grew by 300% between 2005 and 2008. Although the eCTD format is required for any electronic submission and “preferred” by regulators compared with paper, paper CTDs are still allowed. Perhaps ICH will follow suit of FDA and go fully digital in the near-term as well. For in our global age, being able to communicate quickly and electronically is crucial to public safety.