FDA, Biohacking & the “Right to Try” for Families

by on May 9, 2016 · 2 comments

In theory, the Food & Drug Administration (FDA) exists to save lives and improve health outcomes. All too often, however, that goal is hindered by the agency’s highly bureaucratic, top-down, command-and-control orientation toward drug and medical device approval.

Today’s case in point involves families of children with diabetes, many of whom are increasingly frustrated with the FDA’s foot-dragging when it comes to approval of medical devices that could help their kids. Writing today in The Wall Street Journal, Kate Linebaugh discusses how “Tech-Savvy Families Use Home-Built Diabetes Device” to help their kids when FDA regulations limit the availability of commercial options. She documents how families of diabetic children are taking matters into their own hands and creating their own home-crafted insulin pumps, which can automatically dose the proper amount of proper amount of the hormone in response to their child’s blood-sugar levels. Families are building, calibrating, and troubleshooting these devices on their own. And the movement is growing. Linebaugh reports that:

More than 50 people have soldered, tinkered and written software to make such devices for themselves or their children. The systems—known in the industry as artificial pancreases or closed loop systems—have been studied for decades, but improvements to sensor technology for real-time glucose monitoring have made them possible.

The Food and Drug Administration has made approving such devices a priority and several companies are working on them. But the yearslong process of commercial development and regulatory approval is longer than many patients want, and some are technologically savvy enough to do it on their own.

Linebaugh notes that this particular home-built medical project (known as OpenAPS), was created by Dana Lewis, a 27-year-old with Type 1 diabetes in Seattle. Linebaugh says that:

Ms. Lewis began using the system in December 2014 as a sort of self-experiment. After months of tweeting about it, she attracted others who wanted what she had. The only restriction of the project is users have to put the system together on their own. Ms. Lewis and other users offer advice, but it is each one’s responsibility to know how to troubleshoot. A Bay Area cardiologist is teaching himself software programming to build one for his 1-year-old daughter who was diagnosed in March.

In essence, these individuals and families are engaging in a variant of the sort of decentralized “biohacking” that is becoming increasingly prevalent in society today. As I discussed in a recent law review article, biohacking refers to the efforts of average citizens (often working together in a decentralized fashion) to enhance various human capabilities. This can include implanting things inside one’s body or using external devices to supplement one’s abilities or to address health-related issues.

I documented other examples of this trend in my essays on average citizens making 3D-printed prosthetics (The Right to Try, 3D Printing, the Costs of Technological Control & the Future of the FDA) as well as retainers (“In a World Where Kids Can 3D-Print Their Own Retainers, What Should Regulators Do?”) As “software eats the world” and allows for this sort of democratized medical self-experimentation, more and more citizens are likely going to be engaging in biohacking. In the process, they will often be doing an end-around the FDA and its complex maze of regulatory restrictions on health innovation.

Stated more provocatively, thanks to new technological capabilities and networking platforms, the public may increasingly enjoy a de facto “right to try” for many new medical devices and treatments. Technological innovation will decentralize and democratize medical decisions even when the legal status of such actions is unclear or even flatly illegal.

But is a world of increasingly decentralized, democratized, and such highly personalized medicine actually safe? Well, all risk is relative and as I discussed extensively in my recent book and other work on innovation policy, sometimes the greatest risk of all is the refusal to take any risk to begin with. If you disallow or limit efforts to engage in certain risky endeavours, ultimately, you could end up doing more harm because there can be no reward without a corresponding amount of risk-taking. It is only through constant trial and error experimentation that we find new and better ways of doing things. That is particularly true as it pertains to life-enriching or even life-saving medical treatments. While the FDA likes to think that its hyper-cautious approach to medical drug and device approval ultimately saves lives, in the aggregate, we have no idea how many lives are actually being lost (or how much pain and suffering is occurring) due to FDA prohibitions on our freedom to experiment with new products and services.

One of the parents Linebaugh interviewed for her story made the following remark: “Diabetes is dangerous anyway. Insulin is dangerous. I think what we are doing is actually improving that and lowering the risk.” That is exactly right. This father understands the reality of risk trade-offs. There are certainly risks associated with what these families are doing for their children. But these families also have a very palpable sense of the opposite problem: There is a profound and immediate risk of doing nothing and waiting for the FDA to finally get around to approving the devices that their children need right now.

All this raises another interesting policy question: Why is it legal for these parents to engage in this sort of medical self-experimentation–experimentation on their children, no less!–while it remains flatly illegal for any commercial operator to offer similar products that could help these families? Many modern regulatory regimes accord differential treatment to commercial activities. Non-commercial versions of some activities are left alone, but as soon as commercial opportunities arise, policymakers seek to apply regulation.

Does this sort of commercial vs. non-commercial regulatory asymmetry make any sense? As far as I can tell, this regulatory distinction is mostly rooted in the fact that deep-pocked commercial operators make easier targets for regulators to go after when compared to harassing average citizens.  Going after average citizens would be bad PR and a serious legal hassle as well because issues pertaining to personal autonomy or parental rights would likely be raised both in the court of public opinion and courts of law.

Regardless, let’s not kid ourselves into thinking that this regulatory distinction is rooted in safety considerations. After all, it is almost certainly the case that those commercial medical innovators are likely building safer products, made by medical professionals with years of experience. Moreover, commercial operators are more likely to carry insurance to address any problems that may develop, and they possess strong reputational incentives to be good market actors. Commercial operators have to maintain brand loyalty to earn new or repeat business, or perhaps just to avoid stiff legal liability that non-commercial operators might not face. 

In any event, one thing should be abundantly clear: If the FDA doesn’t change its ways, we can expect an increasing number of citizens to begin pursuing medical treatments outside the boundaries of the law (and potentially outside the realm of common sense). Many people want a right to try new devices and therapies, and in our modern networked world, they are increasingly going to get it whether regulators like it or not.

Lawmakers in Congress need to exercise better oversight of rogue agencies like the FDA, which face no serious penalties for the sort of endless regulatory foot-dragging that threatens public welfare. If the agency was required by Congress to improve its drug and device approval process, then perhaps fewer Americans would be forced to take matters into their own hands to begin with. Down below, I’ve included a few reports suggesting how we might get this much-needed reform process started.


Additional reading from Mercatus Center scholars:

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