VCs Turn Up The Heat on FDA to Get Faster, More Predictable

4/25/11Follow @xconomy

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encourages innovation while maintaining a commitment to safety and effectiveness upon which Americans rely and that other countries follow,” Shuren said on Feb. 8 in remarks which are posted on the FDA website. “We must turn what has long been considered the Valley of Death into the Pathway to Success.”

Earlier this month, Versant Ventures’ Beckie Robertson, a veteran medical device investor, told a group of med device entrepreneurs in Bothell, WA, that she’s hopeful change will come to the agency. The FDA, she said, “is a political body, and as political winds shift, so will the FDA.”

There’s certainly a lot of angst on Capitol Hill about the unemployment rate remaining stubbornly high at 8.8 percent nationwide, and nobody in either party wants to be seen as making the problem worse. Jobs, Robertson told med device entrepreneurs, “can and may have some influence” in changing the way FDA regulates the device industry.

Josh Makower

Makower, who testified before the House Energy and Commerce Health Subcommittee on Feb. 17, isn’t quite as confident that the latest bout of activism is destined to succeed. Yesterday, he told me, “at this point from my perspective nothing has yet improved at FDA, so there is no evidence available yet to be optimistic. The mindset and approach through the ranks continues be focused more heavily on risk aversion rather than risk/benefit balance.” He adds: “Since nothing legislatively has changed to get us here, nothing other than leadership, management and vision is required to fix this situation.”

This issue isn’t making headline news just yet, but if it advances further it will generate attention, and it will attract extremists from both sides. Some on the left will accuse the FDA of being industry’s lapdog, and putting public safety in jeopardy, if it moves an inch toward streamlined processes that allow more innovative products on the market. On the right, there are those (like Newt Gingrich in 1995) who would like to abolish or gut the FDA, as if doctors, patients, and insurers in the free market can sort out what’s safe and effective.

Both of those extreme views strike me as wrong and dangerous. I know it’s been said a million times already, and it sounds Pollyannish, but it’s a shame that we live in such a hyper-polarized world that adults can’t debate drug regulation rationally in public. It’s an important issue that deserves more light than heat. Patients have a lot on the line. If we hashed out these issues more in the open, we could hold important agencies like the FDA more accountable, and avoid the extreme rebalancing act the FDA goes through at least once every generation.

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  • JWilly48519

    Those who argue that FDA device regulation is too tough don’t care about either US employment or device safety. Their only focus is short term profits.

    A softened FDA device review process could be a disaster for US device related employment. US dominance of the global device market is directly related to the FDA’s global reputation for being rigorous. End users want the safety and effectiveness that rigorous reviews are more likely to achieve. Soften up that reputation in order for the VCs to get their short-term quicker returns, and we’ll lose our long-term strategic advantage.

    FDA process changes should be off the table unless proof can be provided that a softer, quicker review process delivers unchanged safety and effectiveness.

  • http://ducknetweb.blogspot.com Barbara Duck

    This is a tough battle by all means with ensuring that the technology is also done correctly. Over the weekend something occurred with the Amazon Cloud failure and it left a cardiac monitoring company flat out of business and patients not monitored. This is not a hospital service but rather a home monitoring service that failed for 2 reasons, one of course is Amazon and secondly no back up or disaster plan.

    This brings to light too in healthcare devices as to how deep investors maybe looking before they fund, how much information the company divulged to potential investors and so on as this situation as commented on the boards too said this looked like a start up company perhaps operating on a shoe string budget hoping to maybe raise more money.

    You can read my post and go to the exact site yourself but as you can see the panic attack written on the Amazon boards for help as it was not around. You even see Robert Scoble jump in here on Twitter and he elaborated on the same thing with his comment on how difficult customer service is.

    I see this as a wake up call, especially in light of the new FDA rule for class 1 devices just put into effect and I think this situation may bounce right back over there. I used to write software so I perhaps have a unique view here but I would not want my senior mother on their service as would you. Its a push and pull at the FDA for sure when you bring in all realms of the conversation.

    http://ducknetweb.blogspot.com/2011/04/what-happens-when-cloud-server-goes.html

  • Some Biotech Guy

    Having worked inside venture-funded biotech startups for over a decade, I think there’s some truth to the argument that FDA regs are burdensome, however, there is also a lot of waste that happens inside venture-funded firms that has nothing to do with FDA. Executive staff in startups will report to investors about their project status and it’s easy to say, “FDA took too long so we didn’t meet our goal.” Oh really? FDA took too long or you didn’t design your studies correctly in the first place? Or those ridiculously aggressive goals you had, those weren’t at all unrealistic? Unfortunately, many investors have never worked in the biotech trenches and they don’t know enough about operational details to argue with the “FDA too slow” message from executives. @JWilly48519, I disagree with your first statement. There’s no evidence to say people calling for FDA reg reform don’t care about US or safety. @Barbara Duck, shame on that cardiac monitoring company for setting up such a unstable system. Yes Amazon went down but the only reason that monitoring service went down too is because of their own poor planning. Setting up a seemless failover is trivial and should be part of ANY company providing an internet-based service.

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  • Consumer Voice

    This hysteria and angst with FDA is not going to help industry. Comparing FDA to the EU process is comparing apples and oranges.

    For med devices, the EU has private entities engaged in premarket review on behalf of the 27 EU member nations. The EU Govt bodies directly handle post market information, which is not publicly disclosed like in the US. FDA handles the overall product lifecycle (both premarket review and post market) as compared to the disjointed EU system as noted above. Yes, FDA should not be risk averse. But using partial or omitting information from the EU (because it was unavailable) to conclude that there are no material differences between the EU & US regulatory systems from a safety perspective is somewhat naive.

    The more every move of the FDA is publicly scrutinized, the more risk averse the FDA is going to get.

    The theme that the EU markets are suddenly more desirable is interesting, especially when reimbursement is a challenge. The US continues to be the most profitable market for medtech innovators.

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  • http://www.husick.com/Innov8 Laura White

    CV, I think I understand the point you’re trying to make about increased press leading to increased risk aversion, but I’d say that’s more a fact of the times. It’s not comparisons to EMA or discussions on Xconomy that have decreased risk tolerance, so much as the continued fallout from a global 24 hour news cycle. (Though oddly enough, this effect seems to be a much bigger deal on the pharma end than the food safety side of things.)

    Oddly enough, I have a classmate at Hopkins who also works at FDA and just published an essay on how the agency could adapt some of EMA’s recent reforms to spur US innovation. Interesting read, really – you can find it here: http://www.husick.com/Innov8 – Chapter 9.

  • Consumer Voice

    Laura, There were two points. One was that putting an Agency under a public microscope is bound to make them risk averse.

    The second is that the US should not be moving to a EU Model. Third parties, i.e. businesses, funded entirely by Industry make premarket assessments in the EU. Many of the big players are good – they actually review files. But there are third parties from certain EU countries that rubber stamp anything. And their approval is valid for marketing in all of the EU. Look up the history of soy oil breast implants or metal on metal orthopedic implants.

    We should reform FDA so the Agency updates its regulations for the technologies of today. And fund it so they can hire top notch science experts.

    The point is both sides are talking extremes. And in the public arena.

  • asdf

    as if doctors, patients, and insurers in the free market can sort out what’s safe and effective.

    I know! How crazy for anyone to think that a doctor who went through umpteen years of medical school should be able to prescribe something to an adult patient without a multibillion dollar bureaucracy’s say-so.

  • asdf

    Shuren’s innovation initiative is total BS. There is literally only one project in it, and it’s another government project (a military one) where there was surely some internal lobbying.

    The FDA cannot ensure the safety of a device or drug. People with life threatening conditions who cannot wait ten years for the FDA to approve a drug should have the choice of whether or not they are early adopters. Right now the FDA has sued to prevent them from having that choice. You as a private citizen cannot opt out of the FDA’s embrace.

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