Is Post Marketing Surveillance an new opportunity for MTM

A post marketing requirement (PMR) is a study or clinical trial that a pharmaceutical company is required by statute or regulation to conduct post approval of a drug product.

On December 8, 2017 the FDA released it’s annual report summarizing the status of PMR activity from 2010 – 2016 (see table below).

PMR Status Fiscal Year of PMR Establishment
2010 2011 2012 2013 2014 2015 2016
Pending 8 (4%) 16 (6%) 24 (11%) 56 (20%) 114 (39%) 164 (58%) 232 (86%)
Ongoing 26 (12%) 49 (19%) 52 (24%) 69 (25%) 80 (27%) 52 (18%) 22 (8%)
Submitted 15 (7%) 7 (3%) 9 (4%) 8 (3%) 12 (4%) 16 (6%) 2 (1%)
Delayed 26 (12%) 18 (7%) 25 (11%) 30 (11%) 25 (9%) 13 (4%) 0
Terminated 0 2 (<1%) 1 (<1%) 0 0 1 (<1%) 0
Released 27 (12%) 59 (23%) 30 (14%) 33 (12%) 14 (5%) 5 (2%) 4 (2%)
Fulfilled 122 (54%) 110 (42% 79 (36%) 82 (29%) 48 (16%) 33 (12%) 9 (3%)
Total 224 261 220 278 293 284 269

Pending: The study or clinical trial has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criteria for delayed (i.e., the original projected date for initiation of subject accrual or initiation of animal dosing has not passed).

Ongoing: The study or clinical trial is proceeding according to or ahead of the original schedule.Delayed: The study or clinical trial is behind the original schedule.

Terminated: The study or clinical trial was ended before completion, but a final report has not been submitted to FDA.

Submitted: The study or clinical trial has been completed or terminated, and a final report has been submitted to FDA.

Fulfilled: The final report for the study or clinical trial was submitted to FDA and FDA notified the applicant that the requirement or commitment was fulfilled through written correspondence.

Released: FDA has informed the applicant in writing that it is released from its obligation to conduct the study or clinical trial because the study or clinical trial is no longer feasible, would no longer provide useful information, or the underlying application has been formally withdrawn.

It is interesting to note that after 6 years (2010) only 66% of the PMRs have been completed (terminated, released or fulfilled).  A review of the searchable database of required PMRs indicates that many of the PMRs are observational or pharmacoepidemiologic in nature.  For example one PMR requires”

“Conduct a prospective, multi-center registry including 5000 adult psoriasis patients treated with Humira in the United States. This registry will characterize and assess the incidence of serious adverse events (including serious infections, tuberculosis, opportunistic infections, malignancies, hypersensitivity reactions, autoimmune reactions and deaths) as well as other adverse events of interest in the study cohort. All enrolled study patients will be evaluated for a period of at least 10 years with comprehensive annual reports provided to the Agency. Collect data on the patient characteristics, demographics and drug exposure (including dose, duration and time to onset of adverse event). The collection of data will be via active surveillance methods and data will be validated by a review of medical records as per the guidance for industry titled Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.”

Certainly, an MTM effort could be designed to fulfill the requirements of this registry building effort.  Properly conducted MTM efforts, at their core, are drug focused population health efforts.  Patient assessment is very much a pharmacoepidemiologic / registry creation effort.

This begs the question of whether MTM efforts can do “double-duty” as post marketing surveillance trials, especial when the trial requirement is observational or registry creation.

As always I am happy to discuss your medication therapy management program.  CSS supports health plans, ACOs, integrated care delivery systems, pharmacists and physician groups to design, implement and manage medication management programs.  Feel free to reach out by phone or e-mail.

Jim Notaro

716.541.0273 x101