FDA advisory committee prep: ‘Work hard on Q&A – that’s where you’ll win it,’ says consultant

19-Jun-2018 - Last updated on 19-Jun-2018 at 17:23 GMT

(Image: Getty/aerogondo)

Providing a coherent and persuasive risk assessment and a “well-messaged outline of key communication points” are key to winning US FDA Advisory Committee approval, say industry consultants.

A US Food and Drug Administration (FDA) advisory committee (AC) provides independent advice to the agency during a new drug, or biologic license application process. The group typically includes various industry stakeholders, consumers, and sometimes a patient representative.

According to PharmApprove consultants Martha Arnold and Lisa Peluso – who offer communications and regulatory advice services to market authorisation holders (MAHs) – drugmakers should start preparing for the AC meeting well before submitting their application.

“Once AC meeting preparation begins, create a well-messaged outline of the key communication points, to serve as a roadmap throughout your preparation process. Think before you write!” Peluso told us in the lead up to their talk at the DIA 2018 Global Annual Meeting in Boston, MA.

Unprepared?

MAHs may be unprepared for a meeting with the AC in a number of ways, Peluso said.

According to the speakers, firms which do not take advantage of all communication opportunities available – such as written comments to the docket, or the open public hearing section of the meeting – may be hindered.

Companies not up-to-date with the FDA’s current timelines and procedures for AC meetings may also be unprepared, said Arnold.

The consultants advised MAHs seek “sufficient external, objective expertise and input…make AC preparation the number one priority for key team members, and work hard on Q&A – that’s where you’ll win it.”

Challenges

According to the PharmApprove executives, MAHs should be aware of a number of primary challenges in the lead up to an AC meeting.

“Obtaining sufficient development and rehearsal time from team members – including external experts – who are already over committed” is key, Peluso explained.

In addition, the consultants said balancing focus and attention between the AC and the FDA review division during the meeting is paramount.

The speakers also highlighted the importance of forming a coherent, persuasive benefit and risk assessment – rather than “data dumping” – before presenting to the committee.