The US Food and Drug Administration (FDA) is announcing the launch of a new pilot program that it says will use a common data format to automate part of the submission process for Field Alert Reports (FARs) required of newly approved drug products.
FARs are used by the agency to determine when a newly approved drug poses a potential risk to public health.
Under longstanding regulations, all holders of approved new drug applications (NDAs) and approved new drug applications (ANDAs) must submit FARs to their local FDA district office within three days of being made aware of a problem.
Issues that might lead to the filing of an FAR include a medication being confused for another, contamination in the drug product, quality concerns with the drug product or failure to meet specifications.
Traditionally, that form has been submitted to FDA under Form FDA-3331.
But in its 1 May 2013 Federal Register notice, FDA explained that a new pilot program is "intended to provide FDA with information to allow the agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems."
The pilot program and modernization effort will rely on a new iteration of the 3331 form, known as Form FDA-331-Automated, which will, for the time being, coexist with one another.
As regulators explained on FDA's website, the new form uses an extensible markup language (XML) backbone that turns the Adobe PDF form into a fully electronic one.
"Adobe Acrobat Reader allows firms to use this form during the transition to submit the field alert information with traditional email programs, and no additional software or licenses are required," FDA explained. "Use of XML enables firms to enter data efficiently and allows the data to be validated at the source, eliminating duplication errors when information has to be re-entered."
Benefits and Process
One of the key benefits of the program is that the form is now sent simultaneously to both FDA's regional office and FDA's Center for Drug Evaluation and Research (CDER), whereas before the district office needed to manually send along those reports within five days after receiving them.
FDA added that its ultimate goal is to transition to an entirely electronic system that replaces the paper-based FAR submission procedure. "This pilot program is the first step in that direction," it said.
For now, companies participating in the pilot will still be required to submit signed PDF forms to FDA by email that attest to the accuracy of the form, as well as a paper version of the same form. "This parallel process during the pilot program will ensure delivery of all field alert reports and allow FDA to evaluate the utility of an automated form," it explained.
The pilot program, which FDA notes is open to all members of industry with an active NDA or ANDA, will start on 1 May 2013, and is scheduled to last through 31 December 2013.
"If the pilot is successful, FDA would likely seek to adopt a more permanent, required electronic reporting system, which would be implemented in accordance with existing regulation- and guidance-making processes, as needed," FDA concluded.
FDA's new pilot Form 3331-Automated may be found on its webpage here.
Federal Register Announcement
PILOT- Form FDA 3331-Automated Pilot Program