Happy New Year! Healing Innovation hopes that Santa left you a great gift under the tree that you can enjoy in 2012. Disguised as Jolly Old Nick, the FDA left Healing Innovation a present that we have been wanting for years. The promise of continuity in FDA reviews.
Although it appears to have been released sometime in November, just about Christmas day we unwrapped a standard operating procedure (SOP) from the FDA called “SOP: Management of Review Staff Changes During the Review of a Premarket Submission.”
If you consider this gift tantamount to coal in your stockings, then you have clearly not suffered enough under the enigmatic changes that the FDA can force upon a company undergoing the medical device review process, after an FDA team undergoes personnel changes.
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Let me generally describe one related FDA experience with names and dates left out to protect the victims. My company conducted a pre-IDE meeting with the FDA that was a thoughtful exchange of information and direction, including the medical director’s recommendation (captured in the meeting minutes) that our pilot clinical trial provide 6-months clinical data to gain approval for a larger, pivotal study. Upon returning to the FDA with our results, however, the lead-reviewer and medical director had left the organization and the new medical director calmly explained that 6-month follow-up is an insufficiently short duration.
The old medical director was an experienced staffer, while the new medical director was new to the FDA. The previous lead reviewer managed her team in an efficient manner, while the new lead reviewer was incapable of providing consistent and focused questions from her team. Yet, we had little recourse. In fact, we couldn’t even get another live meeting to better explain our rationale and a conference call required an 8-week lead-time (scheduling lead-time started after the FDA received a modified study protocol and answers to a laundry list of novice questions.)
So, yes, this is the first time I have viewed an SOP as a gift. And, like any holiday present, you don’t know if the results will match the picture on the box.
That said, here’s what the SOP promises on the box:
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- As a general matter, a newly assigned review team member is expected to follow the decisions and advice given by the individual he or she is replacing.
- When staff becomes aware of information that may alter the information and data required for premarket review, they should receive concurrence from the appropriate management level before taking any action.
- For proposed changes in data requirements, staff should ask for data that imposes the least justified burden on the applicant.
- If the newly assigned review team member has a different supervisor than the lead reviewer, then concurrence of the lead reviewer’s supervisor is also required.
Once again, time will tell if this SOP and FDA’s new found transparency initiative will walk the walk. What I like, however, is that the SOP changes the burden. Instead of the company having to push back, the new FDA staffer has the impetus to gain approval from a superior for a change. New staffers are incentivized to only be disruptive when substantial and substantiated reason exists. And, supervisors will have greater responsibility to make a decision and not simply be passive spectators.
Here’s to a healthy and prosperous 2012, including more goodwill from the FDA!
Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
