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By now, you probably know what to expect from the upcoming Advisory Committee meetings in terms of logistics: how to submit written testimony, how to apply for an open public hearing slot, order of the day, etc. (read what an Ad Comm is or watch our webinar with the FDA.) But how does the Advisory Committee prepare for the proceeding, what is the Advisory Committee actually looking for throughout the day, and what can we expect in terms of the discussions and a decision at the end of the meeting?

 

On November 16, PPMD President Pat Furlong chatted with Tim Franson (Your Encore and former Global VP for Regulatory and Drug Safety at Eli Lilly) to get a better understanding of what the Advisory Committee is tasked with and what the Committee’s decisions may mean for the approval of products under review by an Advisory Committee.

 

 

Advisory Committee Marching Orders

 

Questions for the Advisory Committee are selected by the FDA and included in a pre-meeting memo. These questions generally include:

  1. Whether the data submitted by the sponsor demonstrates significant efficacy (clinically meaningful outcomes) for the proposed indication/use and provides necessary information for prescribing for that use;
  2. Whether the data submitted demonstrates sufficient information to define the clinically relevant risks (which are usually termed “adverse events of interest”);
  3. Given the safety and efficacy data, does the aggregate benefit-risk relationship warrant approval for the intended use?; and
  4. Would approval require any specific risk management programs.  Translated, this means developing a strategy to manage known or potential serious risks associated with the drug(s)  This is known as REMS –or Risk Evaluation and Mitigation strategies

 

The FDA may choose to pose additional questions to the Committee but the four topics mentioned above are representative of the questions that will likely be subject to in a formal vote. 

 

Voting

 

The Committee is able to vote independently on each question, so it is possible that the final vote could have some inconsistencies – such as favorable vote on efficacy & safety, but not on benefit/risk for approval.  While this is not the norm, it has happened in the past.

 

Is a Vote Mandatory?

 

A vote is NOT mandatory. The discussion that occurs from this process is actually the goal of the meeting. The hope is to gain insight from patients, experts and other stakeholders in the community.  

 

After the Ad Comm: What’s Next?

Should the Committee render positive votes on the four questions, the FDA review division/office still retains final decision-making authority, and is not obligated to follow the Committee recommendations.

The Divisions options include the following:

As of 2008, there are no longer “not approvable letters” (actually due to Biotechnology Information Organization (BIO) request in PDUFA interactions) but a type 2 complete response essentially indicates the product is “not approvable anytime soon.”

 

We know that there are still a number of if/then scenarios in a lot of people’s minds – and the truth is, no one really knows what is going to happen or what is going to be determined until we know. But we hope that the recent webinar and this blog help to shed a little light on a process that until recently, didn’t seem to directly affect our community.

 

If you have questions about participating in – or attending - either of the upcoming Ad Comms, please do not hesitate to reach out to PPMD.

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