Industry Applauds FDA Electronic Submission Gateway Initiative

Regulated companies that had been nervous about sending esubmissions to the FDA should applaud the agency's new tool to help it receive and process electronic drug, biologic and device applications in an effort to keep up with industry's use of internet submissions, InfoStrength President Rita Geiger told PIR last week.

The agency announced in an Aug. 8 Federal Register notice the availability of its Electronic Submissions Gateway (ESG) to help the FDA handle a growing number of new drug, investigational new drug and biologic license applications and investigational device exemptions submitted electronically. "The increasing number of electronic submissions highlights a critical need to automate and standardize the receipt of these submissions and their delivery to the appropriate centers," the notice said.

"This is a good thing and important step forward because it helps companies feel secure about sending intellectual property over the internet to the FDA," Geiger said.

While noting that it was several years in the making, OfniSystems President Ty Mew also praised the ESG. "It should encourage more companies to migrate to esystems," he told PIR.

The FDA's action addresses the two largest reservations felt most acutely by mid- and small-sized companies: Security fears and new infrastructure costs.

"This allows smaller companies in particular to know they don't have to worry about buying expensive new document management solutions in order to send esubmissions to the FDA," Geiger said. She applauded the agency for recognizing and addressing the fact that many small companies would avoid esubmissions because of cost fears. "Companies won't have to worry about this issue now," she said.

The ESG automates the receipt, acknowledgement to the applicant or sponsor, routing and notification to a receiving center of esubmissions. The use of the ESG is voluntary, the agency said.

The FDA's ESG offers two secure communication options for applicants that already have established gateway systems:

Simple Mail Transfer Protocol (SMTP) with secure/multipurpose internet mail extensions (S/MIME) to provide secure email communication; and Another option that supports faster information exchange and uses hypertext transfer protocol secure (HTTPS) to provide real-time internet communication.

WebTrader is a free applet that can be downloaded from the FDA and requires only a standard security certificate to provide applicants with a secure internet connection to the agency. "The WebTrader addresses the need to expand participation in electronic submissions without costly expenditures for infrastructure upgrades and gateway systems," the agency said in the Federal Register notice.

"All of this will make the industry feel much better about sending esubmissions" to the FDA, Geiger said. In particular, she said the WebTrader option is an effective way to encourage esubmissions because it means that companies will now only need a laptop and a Web connection to send secure esubmissions to the agency. "This is super, it is really helpful for those companies," she stressed.

To use the FDA ESG, send an email to the agency at esgprep@fda.gov (mailto:esgprep@fda.gov) to begin the registration process. The email should include your name, phone number and company name. It should also state whether you are using WebTrader, SMTP or HTTPS for submissions.

To view the Federal Register notice go to: www.fda.gov/OHRMS/DOCKETS/98fr/92s-0251-n000002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/92s-0251-n000002.pdf). To get information on the ESG go to: www.fda.gov/esg/ (http://www.fda.gov/esg/). -- Michael Causey