Reagan-Udall Will Be Transparent: Jane Explains

Pharmalot: What took so long to get to this point and what made it possible to get moving again? Reese-Coulborne: You know, the purpose is to support the mission of the FDA and we have the same structure as the NIH Foundation. The idea was to put together an organization that can create public- private partnerships and work on scientific issues that no one entity can work on by itself… The FDA can’t convene such a partnership because, at the end of the day, whatever comes out of such a group is something they’d have to regulate… We’re independent – we’re a 501(c)3 - but have a special relationship with the FDA… The FDA will be transferring funds appropriated by Congress, but I can also take folks who are FDA employees and have them detailed over to me. And we can raise funds to work on scientific projects that we’re interested in and FDA is interested in. - some educational, some scientific projects…

Pharmalot: why the delay, though? Reese-Coulbourne: We were initially set up in 2007 and supposed to get a transfer of funds from FDA; it was written in to our statute. But a member of Congress was concerned about what we might do and that industry might have influence over us. And funding was withheld. I started as a contractor initially and became executive director 18 months ago. We still didn’t have our transfer of funds, though, which everyone intended was to be used as start up funds. And so I started going after other funding and last June got a grant from the Bill & Melinda Gates Foundation and from the Susan G Komen For the Cure… We’re hoping to get funding transferred soon (from the FDA). Anyway, the Gates Foundation gave a $1 million capacity building grant for a 3-year period and also to work on a TB project. The Komen grant is for a proof of concept looking at cardiotoxicity in a class of oncology drugs. It’s $90,000 and we’re in the process of getting a second round of financing.

Pharmalot: How much are you supposed to receive? Reese-Coulborne: The FDA is supposed to give us between $500,000 and $1.25 million annually.

Pharmalot: So how do you address concerns, though, about private funding and outside influence? The gripe with the PhRMA grant is that the funds are still generated by those with vested interests. Reese-Coulborne: We took a look at what the PhRMA Foundation funded historically and their track record and we were comfortable with what they have been doing. I can assure you we have no influence. They gave us a grant at a time when we really needed money. It bridged us until we got the grant from the Gates Foundation. Downstream, we’re looking at only using for general operations funds money that comes from FDA as well as other non-profit foundations. And we’ll take a percentage of project fundings and put that into overhead operations… Projects will be funded by various sources, government, industry, private sources… The way we try to address the issue is to make everything transparent.

I’m a cancer patient and I really want everybody at the table and I want things to get done. If we eliminate everyone who has ever done anything with industry, we start to eliminate some useful people and important data. We think transparency is the most important thing, and we will let people judge for themselves. We’ve been through a lot of trials and tribulations here, but we’re tyring to work on some important scientific issues and we’re putting a lot of effort into making sure it’s transparent so people know where the funding comes from and who’s sitting at the table.

Pharmalot: What kind of projects will you be working on? Reese-Coulborne: A big focus will be one in which we’ll take methods, a component of the FDA Sentinel project (which was begun three years ago to monitor product safety - read here) and create a long-term methods research agenda. Sentinel will continue to be run by FDA. We’re just going to peel off the methods research portion and we’re going to form an observational medical outcomes partnership. This will be a public-private partnership. We’re going to take what they’ve done so far and will call the program iMeds and look at putting together a fellowship program.

We’re trying to determine whether we can look at safety issues in a scientific way and determine a mechanism of action…. Look at dosing and maybe reverse engineering... This is a really large undertaking. Some projects are large and some are small. Ultimately, the data will be provided to the FDA and will be used for their decision making… We’re trying to finalize this structure now.. The idea is this committee will do oversight and report to the Reagan Udall board… we’re looking at how do we want to put together a public private partnership, what kind of oversight, what kind of stake should they have. We’re in the process of trying to get that together… We need a final scope of work…

We want to have a distributed database, once we have predictive models. You can query safety signals for drugs on the market, but if this works, we hope to have safety signals before we get adverse events…. Right now, we’re in a passive mode waiting for things to pop up. We want to have a proactive system that looks at electronic records and finds safety signals and gives us an early warning… At some point, we may be able to look at efficacy… at some point, we may be able to do a subset analysis… Congress wanted FDA to create a proactive surveillance system…. In the FDAAA, which passed in 2007, there’s mention of the FDA creating such a system… So now this can really happen.