New Proposed Requirements for PIV Certifications and Notice

Continuing in a series of posts on the Proposed ANDA/505(b)(2) Rule, we cover some new requirements for making proper certification and notice of such that are being proposed in the Rule.

Statement of Receipt of PIV Acknowledgment Letter

In order to assure compliance with the timing of notification provisions of the Medicate Modernization Act (MMA), FDA will require a statement in the notice of PIV certification that the applicant has received a paragraph PIV acknowledgement letter.  This is to assure that notice is not given prematurely prior to the ANDA or 505(b)(2) application being accepted for receipt or filing by the FDA.

Dated Printed Copy of Orange Book with Patent listed Will be Required

To assure that applicant only certify to “listed” patents in the Orange Book, FDA is proposing to require a dated copy of the page of the electronic Orange Book that lists the patent.  This will prevent firms from attempting to make PIV certifications to patents that the NDA holder may have but did not list.

Offer of Confidential Access to Accompany Notice

FDA is proposing to require PIV certification to contain an offer of confidential access to the ANDA.  This provision of the Act recognized situations in which the ANDA or 505(b)(2) applicant was not sued by the NDA holder or patent holder after appropriate PIV notice was given. The MMA provision re: declaratory judgment action so the ANDA or 505(b)(2) holder can obtain patent certainty requires such offer of confidential access.  The proposal to require the offer of confidential access is as far as FDA is going in the Proposed Rule because the declaratory judgement process does not involve the FDA.  Thus, FDA is requesting the offer be included in the notice so they can determine if the applicants are meeting the MMA’s statutory provision.

Administrative Consequence for Late Notice

FDA notes that it received several comments on what if any administrative consequence should be associated with a firm that files it PIV notice in an untimely manner.  Because of the significance of this decision, this entire section is being reproduced below:

The MMA does not specify a consequence for 505(b)(2) or ANDA applicants that do not send notice of a paragraph IV certification within the timeframe required by the FD&C Act (i.e., within 20 days after the date of the postmark on the paragraph IV acknowledgment letter or on the date that an amendment or supplement containing a paragraph IV certification is submitted to FDA). In response to our Request for MMA Comments, we received comments suggesting that we create an administrative consequence for late notice (see, e.g., PhRMA MMA Comment at 1 to 2). In light of the importance of the timing of sending notice of paragraph IV certification to the statutory scheme, we agree that it is appropriate to propose an administrative consequence for ANDA applicants who are late in providing notice.

After considering several suggestions for administrative consequences, including those submitted to us in response to our Request for MMA Comments, we are proposing to address ANDA applicants that fail to timely provide notice of a paragraph IV certification by moving forward the date of submission of the ANDA by the number of days beyond the required time frame that the applicant delayed in sending its notice (see proposed § 314.101(b)(4)). Consequently, an ANDA applicant may lose its first applicant status and thus its eligibility for 180-day exclusivity as a result of providing late notice (see section 505(j)(5)(B)(iv) of the FD&C Act), if another applicant submits a substantially complete ANDA containing a paragraph IV certification on the same first day and provides timely notice. Also, an ANDA applicant that fails to timely provide notice of paragraph IV certification may experience a delay in the review queue for its ANDA consistent with the revised date of submission. We note that this proposed administrative consequence would not reduce the 30-month timeframe set forth in section505(j)(5)(D)(i)(I)(aa)(BB) and (j)(5)(D)(i)(IV) of the FD&C Act in the forfeiture calculus for a first applicant; rather, the 30-month period would begin on the revised date of submission.

We believe that the proposed administrative consequence for ANDA applicants appropriately balances the purposes served by the requirement for timely notice of paragraph IV certifications with the legislative goal of speeding the availability of lower cost alternatives to approved drugs. Certain options we considered as alternatives did not seem to provide as measured a balance. For example, we considered deeming paragraph IV certifications for which notice had been provided after the statutory timeframe to not be “lawfully maintained” (see section 505(j)(5)(B)(iv)(bb) of the FD&C Act). Under this interpretation, however, an ANDA applicant would certainly lose its eligibility for 180-day exclusivity as a result of sending late notice, regardless of the amount of time its notice was delayed (e.g., even if its notice were one day late). We decline to adopt this approach because it seems disproportionately punitive.

We are not proposing a similar consequence for 505(b)(2) applicants that fail to timely provide notice of a paragraph IV certification because 505(b)(2) applicants are not eligible for 138180-day exclusivity and we are unable to extend the review clock as an administrative consequence for an NDA (including a 505(b)(2) application) subject to the Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures.

We hope you are benefiting from the provision of this information, albeit in small bites.  We hope it improves your digestion of this important information.