Preparing for Health Authority Interactions and Advisory Committees
by Ronald C. Gossling
Many mainstream and trade journalists have noted recently that the FDA has become more cautious and sometimes harsh in agency reviews of drug/biologic safety and efficacy data. Because of this, professionalism in the presentation of data and responses to division staff and advisory committee questions has become critically important.
To help ensure optimum preparation for FDA interactions, CCA, developers of an innovative team preparatory process, offers the following guidelines and best practices:
Explore Issues Before Messages
When preparing an FDA briefing or sponsor’s presentation for an advisory committee, start by identifying all possible FDA and committee issues. Then develop key messages strong enough to stand alone when compared to the data and issues. This approach may seem counter-intuitive. It may appear far more logical to craft key messages first and leave the issues for later.
Actually the opposite is true. Teams often burn untold hours crafting “perfectly worded message points,” only to discover later half don’t work after taking a close look at the data and the issues.
Key Messages: What do the data say?
Based on the data and outside opinion, formulate key messages to emphasize in the presentation. Be tough – if the data do not support a message, don’t say it! Develop a key message for each section of the presentation and at a minimum craft a proactive, yet scientifically credible, title slide for each section of the presentation. For example, “Manageable Safety Profile” will have more impact than “Adverse Events,” if the data support the claim. “Safer Than Placebo” may be going too far.
Use the team issues list to calibrate each key message. There is little value in spending considerable time crafting an eloquently worded message if it conflicts with a previously prioritized high-risk issue. In addition, decide which issues should be addressed pre-emptively in the presentation, and which should be saved for a question and answer period.
Presenters: Credible Is More Important Than “Smooth”
Pharma teams often spend considerable time fussing about who should present. “Dr. ‘X’ is a much better presenter than Dr. ‘Y,’” the argument goes, “but Dr. ‘X’ doesn’t know the data well.” With appropriate coaching, a less eloquent speaker can often rise to the occasion. Knowledge is more important than smoothness, and credibility is more important than eloquence.
Avoid “Spin”
“You better ’spin’ that point more,” is sometimes heard in rehearsals or planning meetings. Unfortunately, spin rarely gets drugs and biologics approved. Positive statements that exceed the strength of supporting data are “spin.” They can put approval at risk and because agency staff and advisory committee members carry a healthy dose of skepticism to the table, they are rarely successful.
Positive positions are critically important, however it is equally important to underpin each with supporting data, citations from the literature, or expert opinion. Make no claim, without proof of same!
Provide Direct Answers to Troublesome Questions
Anti-spin is answering every question directly, no matter how difficult or embarrassing. This approach may not put a drug, biologic, or device in the best light 100% of the time, but it will add to the sponsor’s credibility – often critical when seeking leniency from the agency or an advisory committee because data may be less robust than hoped for. It is important to have “high ground” to move to following such a confession. For example, “we don’t have the data you are asking for; we do have historical data based on the literature which indicate…” This is often more effective than simply uttering, “I’m sorry, we don’t have that data.” Obviously brainstorming “high ground” positions and corresponding supporting evidence in advance, is beneficial.
Don’t Assume an Issue is “Dropped”
More often than sponsors would like, an issue worked with the agency for months and finally put to rest, comes up again at advisory committee. If sponsor team members have decided the issue needs no more work because it is no longer of interest to the agency, they may get broadsided at committee.
For example, sponsors of an oncology drug finally put a statistical issue to rest with division staff. The statistician familiar with the agency’s concern breathed a sigh of relief and refused to deal with the question again in coaching sessions or rehearsals. To her surprise, she spent 15 minutes defending the issue before ODAC. Lesson learned: don’t assume any issue is “dead” at committee.
Planning and Rehearsing Answers is as Important as Discussing Answers
See if this sounds familiar: the meeting to address five “killer issues” lasted four hours. The discussion was brisk and the exploration of conflicting opinions was exhilarating. The meeting ended without closure on any issues.
Here is an alternative. Divide the team into specialty areas (regulatory, preclinical, efficacy, safety, biostatistics for example). Give each specialty team a single sheet of paper and one key issue to resolve. Ask teams to develop a draft, bullet-form answer including a 1-2 sentence position (“high ground”) and corresponding supporting evidence (data, literature, or expert opinion). Upon completion, teams trade answers, conduct an informal peer review of another team’s work, and return their comments to the original authoring team for refinement.
Once refined, to ensure other interested parties have an opportunity for input, ask a spokesperson for each specialty team to “flight test” their answer for the full team. The results? Five draft responses to five troublesome issues within 2-3 hours!
Outside Experts Need to Rehearse
“They wouldn’t be outside experts if they couldn’t perform well,” is sometimes expressed by sponsor teams. That is not the point. It is important to know what an expert will say under pressure in the presence of his or her peers.
That pressure can be simulated by having all team members questioned by mock committees including outside experts and company representatives. Discussions with an expert asked to sit with you at committee are valuable, but they may not reveal what that individual will actually say at the meeting. Mock committee rehearsals, although not real life, reflect with some accuracy how team members will perform in the “real thing.”
Who Should Moderate Q & A?
Logic would tell you a moderator with no responsibilities other than getting the right question to the right person is the best approach. However, advisory committees tire of dealing with an intermediary if that person cannot or does not answer questions as part of the job.
A clinical lead who is close to the data often makes the best moderator. True, it is a heavy burden to answer questions as well as triage multi-part questions, but many former advisory committee members have expressed that since time is short, they prefer to deal with “a moderator who can address many of the issues.” The goal: get information to the committee as directly and quickly as possible.
Ronald Gossling is the founder of CCA.
