September 15, 2011
The Wall Street Journal / VC Dispatch
VC-Focused Group Says More Voices Better In Pushing FDA Reform
Venture capital investors and the companies they support closely watch what’s happening at the U.S. Food and Drug Administration, the agency companies must navigate to get their drugs and devices approved for commercialization.
They do more than watch, in fact — the industry is increasingly intent on changing the way things work at the regulatory level.
The Medical Innovation and Competitiveness Coalition is one of two organizations in the venture industry that has been pushing for reforms to the FDA. Like the Medical Device Venture Council, MedIC says there is a risk-averse culture at the FDA that has been stifling innovation and driving jobs overseas (Read VentureWire’s reporting on the issue here). MedIC has been making trips to Washington to get FDA officials and policymakers to make changes to the agency.
Formed last year in partnership with the National Venture Capital Association, MedIC is chaired by Dr. Beth Seidenberg, a partner at Kleiner Perkins Caufield & Byers and a former top executive with Amgen Inc. Seidenberg spoke with VentureWire about some of the indications that the FDA is beginning to listen.
First of all, why are there two different groups lobbying for FDA changes? Would it make sense to join forces?
The two groups are very much aligned, but we are different. The MDVC has a focus on devices, and it’s comprised of venture capitalists only. MedIC, our group, has 125 members, and more than half of them are entrepreneurs. We represent the whole spectrum of life-sciences investing. While it could make sense to combine, it’s also good to have more voices.
In your opinion, what’s the main problem at the FDA?
The major problem is the lack of predictability, which leads to delayed timelines. Entrepreneurs are smart people, and they want to get their products to patients. And because of the lack of transparency, and the lack of consistency (at FDA), they are moving to Europe, setting up their organizations and creating jobs overseas.
When your members go to Washington to get attention paid to these issues, who do you talk to?
The primary thing here is creating awareness, so we’re talking to the right people. We meet with (Center for Devices and Radiological Health Director) Jeff Shuren, we talk to (FDA Commissioner) Peggy Hamburg. We talk to lawmakers. Having data to put in front of people does generate attention.
What indication are you getting that your group and the MDVC are being taken seriously? Are you seeing actual changes at the FDA?
The first thing to say about that is that there’s a very long way to go. We’re at the beginning of a long process. But the message has been getting through. The FDA really has been trying to address these issues. Shuren has been out and about, talking to people. He’s been meeting with entrepreneurs. When the FDA wants to make a change, they put out guidance documents (where they seek public input). There is a guidance document out about their risk/benefit analysis, and there is one about the issue of European approvals moving faster. They’ve put out a whole set.
Another thing: Last week the FDA announced a training program, where they are going to bring people in who can improve [FDA reviewers’ knowledge of medical technologies, in order to speed up the process]. So, there is still a long way to go. But we are beginning to see approvals come through with more transparency, and more rapidly.