The U.S. Food and Drug Administration holds more than 2,000 meetings a year with 1,800 companies who are all trying to get the information they need to get a drug approved or a medical device cleared.
Meetings happen at various stages, typically at key milestones of a product’s development. With so many FDA meetings, it can be hard to get on the FDA’s calender. But it’s not enough to get the meeting, said Mark Baumgartner, senior director, global regulatory affairs for GlaxoSmithKline (NYSE:GSK). You’ve got to make the most of the meeting time that you have. A growing number of these meetings are with “emerging sponsors,” typically smaller, venture capital-backed companies that have never taken a drug to market. The FDA realizes that emerging sponsors need more guidance than large pharmaceutical companies. If you’re one of them, a little preparation — actually, a lot of preparation — goes a long way.
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Baumgartner was among the speakers at a recent CED Biotech Forum panel in Research Triangle Park, North Carolina who discussed how to work with the FDA. He was joined by attorney Michael Hinckle, partner at K&L Gates, and Andrew Finn, executive vice president of product development at Raleigh pharmaceutical company BioDelivery Sciences International (NASDAQ:BDSI). Here are some highlights from the panel:
Requesting a meeting. Just because you think you need a meeting doesn’t mean the FDA thinks you need a meeting. Ask general questions in your meeting request, Baumgartner said. You can get more specific in your briefing documents. But be focused. The briefing documents should not deviate from your original questions. A company must give enough context about the kind of information needed to justify a meeting. If your questions are not significant enough, Hinckle said, the FDA will just answer your questions then deny a meeting to discuss them.
Planning, part 1. Start your meeting preparations early, even before you’ve requested the meeting. If you hold off on planning until the FDA grants you a meeting, you won’t have enough time. It’s not unusual for the FDA to provide written responses to your questions just 48 hours before the scheduled meeting. In some cases, Baumgartner said, you might get those responses the morning of the meeting. Have a plan A and a plan B, Finn said. If the FDA gives you an answer and it’s not the answer you’re looking for, you need to be able to respond in a way that allows you to get the information that you need.
Planning, part 2. Conduct a mock meeting. FDA staff will have met together before they meet with a company. Your company should meet beforehand, too. Practice meetings are particularly helpful for those who have never met with the FDA before. Someone who is familiar with FDA meetings can stand in for the agency. Even for those who are experienced in FDA meetings, a practice meeting helps a company form a plan for the meeting. When the real meeting happens and the FDA asks a question about a particular topic, your plan should make clear who is responsible for responding to that question.
During the meeting, ask the right questions. Understand the applicable guidelines and procedures. If you ask something procedural that you could have easily looked up yourself, you’ve wasted a question, lost time and perhaps missed an opportunity to get key information on something else that you needed. “If you ask everything you can think of, you’re going to get a lot of little stuff that’s not helpful,” Finn said. Meeting times with the FDA are precious and you want to make the most of that time, Baumgartner said.
There is one question you should never ask the FDA. Don’t ask “What will it take to get my drug approved?” The FDA is not your consultant, Baumgartner said. It’s up to you to make the case for the studies you’re doing and the data you’re presenting. Consultants can help you figure out how to best present that information to the agency. The FDA is not going to have an answer that tells you that if you do or submit something, you’ll get approval. You make the case that the data you submit supports approval. The FDA will respond to what you present.
And after the meeting is over … your meeting is not over. It’s important that the company regroup immediately after the FDA meeting in order to debrief, Baumgartner said. The more time that passes, the more each individual’s reflections and recollections on the meeting can change. Keep everyone on the same page and make sure everyone’s clear on what was gained from the meeting and what will happen next.
[Image from stock.xchng user Sigurd Decroos]
