Ten days ago, I got a last-minute invitation to attend a small Bay Area JDRF event at the Four Seasons Hotel in Palo Alto, in the heart of Silicon Valley. This is where technology happens. It turns out, this diabetes-tech-update event has been going on for a few years. I was especially excited, because the theme of this year's program was FDA Reform: How Can We Remain Competitive While Protecting Public Safety? Now that sounded like a breakfast of champions!
However, this event was rather frustrating — and also encouraging — all in one.
What was encouraging was seeing a room full of about 60 well-educated, well-spoken, well-connected and enthusiastic supporters of the cause, gathered together to hear and discuss progress. Kelly Close and Adam Brown of diatribe were at my table! And I so enjoyed meeting activist D-Mom Tamar Sofer-Geri!
Everyone in that room was sitting up straight over their lovely meal (fruit, scrambled eggs, chicken sausage and the best hash browns I've ever had in my life), straining to catch every word the panel of experts said.
The panel consisted of -
Mark Fischer-Colbrie, President and CEO, Labcyte Inc.
Emory Anderson, President and CEO, Intuity Medical
Michael J. Billig, Co-Founder and CEO, Experien Group
Dr. Bruce Buckingham, Professor, Stanford School of Medicine
John F. Maroney, General Partner, Delphi Ventures
Michelle Rohrer, Vice President Regulatory Affairs, Genentech
The whole shabang was sponsored by Stanford School of Medicine, BayBio Life Science Association, and business law firm Latham & Watkins. Turns out one of the law firm's partners is on the Greater Bay Area JDRF board, and the firm's been committed to supporting JDRF for some time.
I understand the MSRP was $100 a plate, or $1,500 to sponsor a whole table (10 seats) and proceeds were all donated to JDRF, so that's all good.
Now here's the frustrating part:
It was a bit like holding an event about reforming the Supreme Court, without inviting anyone who works in or for that branch of government. In other words, with all due respect to the esteemed panel, no one was there who has any real insider knowledge of FDA or any real sway in reforming their procedures. The individuals from Experien and Genentech have deep experience in "regulatory affairs," to be sure, but as I learned at my own medical device design Summit event in September, that is not the same as having someone on hand who's actually a current or former employee of FDA.
Given the title of this event, I was surprised there wasn't even anyone on hand who was directly involved in the recent expert panels confronting FDA on their messed-up, dragged-out, patient-ignoring evaluation process.
I was also surprised to see a representative from Intuity on the panel, since that company's been stuck trying to get its relatively simple all-in-one BG testing device through FDA for at least three years! I was hoping for some insights on "how not to get stuck in FDA limbo," but instead, all we got was a lot of nostalgia over how much better things used to be working with FDA, and a bunch of lamenting over what a mess the FDA landscape is in. Some quotes I took down:
- "There's been a real slow down in recent years. Products that used to take 90 days to get through evaluation now take 15 months... You used to be able to call up the agency and actually get someone on the phone. Now that would be impossible! There's just layers and layers of bureaucracy" — Michael Billig, Experien Group
- "We fought for a meeting with FDA for so long! Then we finally got it in November 2010. We had 15 people there, including all our top medical advisers. They kept saying they didn't need a meeting because they already understood the technology, but after we finally had the meeting, they said, 'it's good you came in, now we finally understand the technology.'... They're figuring out a lot of things related to cleaning and disinfection... FDA needs a new process for evaluating innovation!" — Emory Anderson, Intuity Medical
- "They're looking for everything that can and will go wrong. It's really eye-opening working with them. The last application we submitted was like 300 pages long; we couldn't do a research grant like that! We had to redo the low glucose suspend studies because the Navigator was no longer available; we were using a different product to test the concept.... I keep reminding them that what's approved needs to be patient-friendly, life-friendly, too. We're calling not just for guidance, but good guidance!" — Dr. Bruce Buckingham, Stanford Medicine
- "The FDA is asking for things that are just nuts. They're wanting to insert endpoints in studies that aren't necessary and make no sense. My advice to companies is to communicate early and often with FDA. Go to those meetings with your key physicians and maybe even a patient (!!!)... If you hit a snag, hit the 'appeal button' asap. You have no idea how long that appeal process may take" — John Maroney, Delphi Ventures
Errr, it was great to hear at least one expert suggesting more patient representation in FDA meetings... but the dialogue was mainly focused on what currently sucks. Now if it were up to me, I'd have had easel boards by every table so attendees could start brainstorming ways to change this bogged-down process! And that doesn't necessarily mean re-inventing the world:
As per the authors of the seminal book Made to Stick, "Instead of asking ourselves, 'What's broken and how do we fix it?,' we need to ask ourselves, 'What's working and how can we do more of it?'"
But that's just me; no one asked me.
A number of folks, including Kelly Close, pointed to JDRF's active lobbying of Congress and how important that is. "JDRF's done more on Capitol Hill in recent years than's been done in the history of this disease, and that's amazing," she said. True that. But does it translate into real improvements at FDA?
"We're just not yelling loud enough as an organization for the FDA and politicians to pay attention to us," said moderator Mark Fischer-Colbrie.
Well, some kind of pressure must be taking hold over there, because just in the last two weeks, three new diabetes devices have cleared the corral: Tandem's t:slim pump, the iGlucose BG meter reader, and Medtronic's new next-generation iPro CGM (for use under doctor's direction only; patients don't see the data in real-time). Listening to the talk at this breakfast, I wouldn't have thought it possible.
In any case, I hope to be invited back to JDRF's Silicon Valley update next year (this post not withstanding), and see perhaps more of an action-oriented agenda next time around...?