FDA Issues Change to Make it Easier to Submit Citizen Petitions

| 18 December 2013 | By Alexander Gaffney, RAC, 

It's about to become a lot easier to submit Citizen Petitions to the US Food and Drug Administration (FDA), the agency has announced.

The petitions are essentially formal requests made to FDA to take an action-approve a product, declare that a product was not withdrawn from the market for safety reasons, institute a new policy, or even refrain from approving a generic drug product based on potential problems.

The wide range of potential uses for the petitions makes them a staple of many companies, trade groups, law firms and advocacy groups.

There's just one problem: Filing them can be extremely difficult. While comments may be submitted to FDA electronically, at present Citizen Petitions must be submitted in writing.

"The current regulation does not recognize electronic methods for submitting citizen petitions," FDA explained in an 18 December 2013 Federal Register notice.

Under new modifications to 21 CFR 10, FDA said it will allow Citizen Petitions to be submitted through "electronic methods" while preserving the ability for anyone to submit petitions through existing paper-based methods.

The new section will read as follows:

Electronic submission. Petitions (including any attachments) may be electronically submitted in accordance with paragraph (b)(3) of this section and § 10.20 through http://www.regulations.gov at Docket No. FDA 2013-S-0610. It is only necessary to submit one copy.

Federal Register Notice