This is a first in a series of posts that will outline some of the more interesting and unique changes that the FDA is making in its Proposed Rule issued last week and that we covered here.
The FDA has discussed the timing of the notice to patent holders and NDA holders when an ANDA or 505(b)(2) NDA applicant files a paragraph IV certification. The statute required the notice to be sent within 20 days from the “postmark” on the letter acknowledging that the ANDA or 505(b)(2) application had been received or filed (respectively). This language actually required to FDA to pay for postage for these letters where all other government letters are sent free. So the Document Room at FDA actually had to physically bring these acknowledgment letters to the post office to get them stamped with the postmark and pay for postage when mailed.
In the new Proposed Rule, the FDA is trying to save money by redefining what “postmark” actually means and also recognizes that the landscape for mail delivery is changing. The Proposed Rule states:
We are proposing to define the term “postmark” in § 314.3(b) to address the MMA’s requirement that a 505(b)(2) or ANDA applicant send notice of its paragraph IV certification within “20 days after the date of the postmark on the notice [i.e., the paragraph IV acknowledgment letter] with which [FDA] informs the applicant that the application has been filed” (see section 505(b)(3)(B)(i) and 505(j)(2)(B)(ii)(I) of the FD&C Act). The term “postmark” is not used elsewhere in section 505 of the FD&C Act or in our current regulations in part 314. In light of the transition by FDA and regulated industry to electronic communications, an interpretation of the term “postmark” to mean a postmark made by the U.S. Postal Service(“U.S. postmark”) could quickly become outdated. The purpose of the postmark in section 505(b)(3)(B)(i) and (j)(2)(B)(ii)(I) of the FD&C Act is to establish a verifiable date from which the 20-day notice period runs. Accordingly, we are proposing a broader definition of a “postmark” to mean “an independently verifiable evidentiary record of the date on which a document is transmitted, in an unmodifiable format, to another party. For postmarks made by the U.S. Postal Service or a designated delivery service, the date of transmission is the date on which the document is received by the domestic mail service of the U.S. Postal Service or by a designated delivery service. For postmarks documenting an electronic event, the date of transmission is the date (in a particular time zone) that FDA sends the electronic transmission on its host system as evidenced by a verifiable record. If the sender and the intended recipient are located in different time zones, it is the sender’s time zone that provides the controlling date of electronic transmission.
FDA is relying on a similar term to what the IRS uses, “electronic postmark”. This makes sense and will save the FDA both time and money and will likely speed acknowledgement letters to applicants, which in turn will allow them to provide their paragraph IV notice faster. The FDA asks for comments on this proposal, so remember that this is a Proposed Rule and is cannot be implemented at this time.
For those of you who wish to comment on any provisions of the Proposed Rule, the link to the document on regulations.gov can be found here.