The Beat Goes On – More On the Proposed Rule

This edition of the Proposed Rule saga covers a few more interesting issues.  The rule-which was 11 years in the making (longer than the final Hatch-Waxman rule on the patent and exclusivity provisions of the Act, which was10 years in the making) really tightens up some of the long-established practices of the Agency and explains why the FDA is taking the actions that it is.  Makes for good reading, but make sure you have your toothpicks ready to prop open your eyes.  We are just through page 120 of the 300+ pages.

FDA For 3542 – Soon to be Online?

There are many requests being made through FDA’s Freedom of Information (FOI) program for the information on the FDA Form 3542 which is the form submitted after approval of an NDA or supplemental NDA to provide information to FDA on the patent that covers the approved drug, drug product, or method of using the drug.  Information on the forms is useful for determining the address and identity of the patent holder, if other than the NDA applicant, specifics on the use of the product, and the address of the US agent of the patent holder if they reside outside of the US. Because the FDA anticipates getting “additional requests for the information submitted on Form FDA 3542”, “they may elect to proactively post on FDA’s Web site a copy of Form FDA 3542 for patents listed in the Orange Book in advance of a request under the Freedom of Information Act.”  This would be a big help for FDA relative to manpower, and also to applicants needed to gain access to this data.  While we do not have an idea of FDA’s timetable for implementing this proactive initiative, at least it is on the horizon as something that could possibly happen.

Challenge that Use Code is Overly Broad:

This discussion in the Proposed Rule is very interesting and provides an example that should be reviewed by all readers.  The example is just too long to cite here, but it appears on page 93 of the document (the Rule can be found here).  Suffice it to say that the FDA’s proposed provisions for the challenge to a patent listing relative to the Use Code submitted by the applicant will undergo more scrutiny if challenged, but FDA will likely give deference to the applicant if the labeling clearly supports their contention.  This will be a sticky wicket for certain.

Sending PIV Notice to NDA holder and Patent Holder after Submission of Amendment or Supplement

FDA has clarified its stance on the required date of submission of a PIV notice letter for both amendments and supplements,  as it says, “Also, we note that FDA may send an acknowledgment letter for certain types of supplements (e.g., a supplement to an ANDA seeking approval for a new strength of a drug product; a 505(b)(2) supplement to an NDA seeking approval for a new indication, new dosage regimen, new route of administration, or a change from prescription use to OTC status for all conditions of use).  However, this practice would not alter the 505(b)(2) or ANDA applicant’s statutory obligation to send notice of a paragraph IV certification at the time the supplement is submitted to FDA (and not at the time the paragraph IV acknowledgment letter for the supplement may be received).”  This clarification answers a question that has been floating around for years and especially under GDUFA, if a supplement is refused for filing for a new strength, the question as to how the FDA would treat the notice to the NDA and patent holder is unclear.  This could work in the innovator’s favor if the notice must be sent the day that the amendment or supplement is sent, and if FDA denies the filing or receipt of a supplemental application, then the innovator would know what may be coming down the line.  How FDA would handle the date of the notice in a case like this is not outlined, but one would assume that the notice might not be considered valid if the supplement is not received or filed.  Certainly, this would be a good question to ask the Agency in comments to the Proposed Rule.

That does it for today.  After our eyes stop watering, we will be back at descriptions of some other interesting portions of the Proposed Rule.  But be advised, we are not covering everything so we advise you to go through the entire Rule with a fine toothed comb.  You may find something that your firm really wants to comment on, so please do.