What? More on the Proposed Rule – Just Think How I Feel, but this is the Last Post on the Proposed Rule!

There are so many issues covered by the Proposed 505(b)(2) and ANDA Rule that we can fill a book with the explanations (and we almost have).  But we are giving you the Readers Digest condensed version in these posts.  Be certain to read the entire Proposed Rule and watch for comments on Regulations.gov to get an idea of which sections will provide more controversy than others.  Today, we will focus on a few areas relating to some interesting challenges that FDA will face.  Remember that the Proposed Rule was drafted a while back, and some of the provisions appear to be timely in the drug approval world as some real life situations have occurred since it was first published.

Delay of Approval Due to Exclusivity

It is funny how some things buried in a Federal Register Notice have a way of popping up at very opportune times.  It has been long-standing practice for FDA to permit carve outs of Orphan Drug indications when there are other non-protected indications in the labeling, but since the statute that governs the award of Orphan Drug exclusivity was passed prior to the Hatch-Waxman Act in a separate piece of legislation, FDA never specifically addressed the impact of, or how they would treat Orphan Drug exclusivity in the final Hatch-Waxman regulations.  Now FDA is proposing to clarify in sections 21 CFR 314.107(d) that approval of a 505(b)(2) or ANDA application will be delayed by Orphan Drug Exclusivity and Pediatric Exclusivity (another exclusivity that was statutorily passed, but after the Hatch-Waxman regulations were in place, but again were never explicitly addressed).  This comes at a time when the FDA is being sued over a firm’s contention that there are no regulatory or statutory provisions that permit carve out of an Orphan Drug indication (see recent FDA Law Blog posts on this subject for details [search on Orphan Drug exclusivity here]).

Notification of Court Actions or Documented Agreements

FDA has found that obtaining proper documentation of court actions and settlement agreements has been spotty at best, and FDA often learns about these actions at the 11th hour, making approval decisions difficult when such an action may impact their decision-making process.  Now FDA is proposing regulations that would require a 505(b)(2) or ANDA applicant to provide notification to the Agency along with documentation of any such action, including the court decisions, within 14 days of any such action or settlement agreement.  Such actions would include findings relative to patents, termination of 30-month stays or the 7.5 year period (if applicable), preliminary injunctions or lifting of an injunction, notice of settlement agreements (but does not require the submission of the actual settlement agreement) and/or Consent Decrees relative to the patent decision, and notice of appeals of any court decision submitting within the time permitted for appeal.

This is an increased burden on the applicants, but necessary, so that FDA can make approval decisions in a timely manner.

Date of Implementation and Impact on Submissions

FDA proposes the effective date of the Final Rule to be 60 days after its publication in the Federal Register.  In addition, FDA intends to apply the provisions of the Rule (if finalized) to any submission made on or after the effective date of the regulation.

Well, this process had been fun and we hope you have enjoyed reading about the Proposed Rule.  Now we will just sit back and wait for its finalization or re-proposal (not likely) along with the flood of comments FDA is likely to receive.  When will the Rule be finalized?  Good question, but one with the only answer that makes sense-“soon”.  When I was at FDA, I coined the Agency definition of “soon” as “between now and whenever it happens”.  And that you can take to the bank!