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: Continue reading →
The Federal Trade Commission (FTC) is taking a more active interest in state and local barriers to entry and innovation that could threaten the continued growth of the digital economy in general and the sharing economy in particular. The agency recently announced it would be hosting a June 9th workshop “to examine competition, consumer protection, and economic issues raised by the proliferation of online and mobile peer-to peer business platforms in certain sectors of the [sharing] economy.” Filings are due to the agency in this matter by May 26th. (Along with my Mercatus Center colleagues, I will be submitting comments and also releasing a big paper on reputational feedback mechanisms that same week. We have already released this paper on the general topic.)
Relatedly, just yesterday, the FTC sent a letter to Michigan policymakers about restricting entry by Tesla and other direct-to-consumer sellers of vehicles. Michigan passed a law in October 2014 prohibiting such direct sales. The FTC’s strongly-worded letter decries the state’s law as “protectionism for independent franchised dealers” noting that “current provisions operate as a special protection for dealers—a protection that is likely harming both competition and consumers.” The agency argues that:
consumers are the ones best situated to choose for themselves both the vehicles they want to buy and how they want to buy them. Automobile manufacturers have an economic incentive to respond to consumer preferences by choosing the most effective distribution method for their vehicle brands. Absent supportable public policy considerations, the law should permit automobile manufacturers to choose their distribution method to be responsive to the desires of motor vehicle buyers.
The agency cites the “well-developed body of research on these issues strongly suggests that government restrictions on distribution are rarely desirable for consumers” and the staff letter continues on to utterly demolish the bogus arguments set forth by defenders of the blatantly self-serving, cronyist law. (For more discussion of just how anti-competitive and anti-consumer these laws are in practice, see this January 2015 Mercatus Center study, “State Franchise Law Carjacks Auto Buyers,” by Jerry Ellig and Jesse Martinez.) Continue reading →
Regular readers know that I can get a little feisty when it comes to the topic of “regulatory capture,” which occurs when special interests co-opt policymakers or political bodies (regulatory agencies, in particular) to further their own ends. As I noted in my big compendium, “Regulatory Capture: What the Experts Have Found“:
While capture theory cannot explain all regulatory policies or developments, it does provide an explanation for the actions of political actors with dismaying regularity. Because regulatory capture theory conflicts mightily with romanticized notions of “independent” regulatory agencies or “scientific” bureaucracy, it often evokes a visceral reaction and a fair bit of denialism.
Indeed, the more I highlight the problem of regulatory capture and offer concrete examples of it in practice, the more push-back I get from true believers in the idea of “independent” agencies. Even if I can get them to admit that history offers countless examples of capture in action, and that a huge number of scholars of all persuasions have documented this problem, they will continue to persist that, WE CAN DO BETTER! and that it is just a matter of having THE RIGHT PEOPLE! who will TRY HARDER!
Well, maybe. But I am a realist and a believer in historical evidence. And the evidence shows, again and again, that when Congress (a) delegates broad, ambiguous authority to regulatory agencies, (b) exercises very limited oversight over that agency, and then, worse yet, (c) allows that agency’s budget to grow without any meaningful constraint, then the situation is ripe for abuse. Specifically, where unchecked power exists, interests will look to exploit it for their own ends.
In any event, all I can do is to continue to document the problem of regulatory capture in action and try to bring it to the attention of pundits and policymakers in the hope that we can start the push for
real agency oversight and reform. Today’s case in point comes from a field I have been covering here a lot over the past year: commercial drone innovation. Continue reading →
If you want a devastating portrait of how well-intentioned regulation sometimes has profoundly deleterious unintended consequences, look no further than the Federal Aviation Administration’s (FAA) current ban on commercial drones in domestic airspace. As Jack Nicas reports in a story in today’s Wall Street Journal (“Regulation Clips Wings of U.S. Drone Makers“), the FAA’s heavy-handed regulatory regime is stifling America’s ability to innovate in this space and remain competitive internationally. As Nicas notes:
as unmanned aircraft enter private industry—for purposes as varied as filming movies, inspecting wind farms and herding cattle—many U.S. drone entrepreneurs are finding it hard to get off the ground, even as rivals in Europe, Canada, Australia and China are taking off.
The reason, according to interviews with two-dozen drone makers, sellers and users across the world: regulation. The FAA has banned all but a handful of private-sector drones in the U.S. while it completes rules for them, expected in the next several years. That policy has stifled the U.S. drone market and driven operators underground, where it is difficult to find funding, insurance and customers.
Outside the U.S., relatively accommodating policies have fueled a commercial-drone boom. Foreign drone makers have fed those markets, while U.S. export rules have generally kept many American manufacturers from serving them.
Of course, the FAA simply responds that they are looking out for the safety of the skies and that we shouldn’t blame them. Continue reading →
The use of unmanned aircraft systems, or “drones,” for private and commercial uses remains the subject of much debate. The issue has been heating up lately after Congress ordered the Federal Aviation Administration (FAA) to integrate UASs into the nation’s airspace system by 2015 as part of the FAA Modernization and Reform Act of 2012.
The debate has thus far centered mostly around the safety and privacy-related concerns associated with private use of drones. The FAA continues to move slowly on this front based on a fear that private drones could jeopardize air safety or the safety of others on the ground. Meanwhile, some privacy advocates are worried that private drones might be used in ways that invade private spaces or even public areas where citizens have a reasonable expectation of privacy. For these and other reasons, the FAA’s current ban on private operation of drones in the nation’s airspace remains in place.
But what about the
speech-related implications of this debate? After all, private and commercial UASs can have many peaceful, speech-related uses. Indeed, to borrow Ithiel de Sola Pool’s term, private drones can be thought of as “technologies or freedom” that expand and enhance the ability of humans to gather and share information, thus in turn expanding the range of human knowledge and freedom.
A new Mercatus Center at George Mason University working paper, “News from Above: First Amendment Implications of the Federal Aviation Administration Ban on Commercial Drones,” deals with these questions. This 59-page working paper was authored by Cynthia Love, Sean T. Lawson, and Avery Holton. (Love is currently a Law Clerk for Judge Carolyn B. McHugh in 10th Circuit U.S. Court of Appeals. Lawson and Holton are affliated with the Department of Communication at the University of Utah.)
“To date, little attention has been paid to the First Amendment implications of the [FAA] ban,” note Love, Lawson, and Holton. Their article argues that “aerial photography with UASs, whether commercial or not, is protected First Amendment activity, particularly for news-gathering purposes. The FAA must take First Amendment-protected uses of this technology into account as it proceeds with meeting its congressional mandate to promulgate rules for domestic UASs.” They conclude by noting that “The dangers of [the FAA’s] regulatory approach are no mere matter of esoteric administrative law. Rather, as we have demonstrated, use of threats to enforce illegally promulgated rules, in particular a ban on journalistic use of UASs, infringes upon perhaps our most cherished constitutional right, that of free speech and a free press.” Continue reading →
I thought Todd Zywicki, a senior scholar with the Mercatus Center at George Mason University, did a nice job on Judge Napolitano’s “Freedom Watch” show addressing the contentious question of whether government should be regulating food advertising in order to somehow make American kids healthier. Todd pointed out how the advertising guidelines currently being developed are anything but “voluntary” and noted that there are many causes of childhood obesity. Watch the clip here:
Federal policy makers, state legislators, and state attorneys general have recently shown interest in regulating commercial advertising and marketing. Several new regulatory initiatives are being proposed, or are already underway, that could severely curtail or restrict advertising or marketing on a variety of platforms. The consequences of these stepped-up regulatory efforts will be profound and will hurt consumer welfare both directly and indirectly.
I go on to note that “advertising can be an easy target for politicians or regulatory activist groups who make a variety of (typically unsubstantiated) claims about its negative impact on society,” but then continue on to explain how “the role of commercial speech in a free-market economy is often misunderstood or taken for granted.” I outline how, despite regulators’ concerns, consumers actually derive three important types of benefits from advertising and marketing: (1) Informational / Educational Benefits; (2) Market Choice / Pro-Competitive Benefits; and (3) Media Promotion / Cross-Subsidization. After discussing each benefit, I conclude that:
For these reasons, a stepped-up regulatory crusade against advertising and marketing will hurt consumer welfare since it will raise prices, restrict choice, and diminish marketplace competition and innovation—both in ad-supported content and service markets, and throughout the economy at large. Simply stated, there is no free lunch.
Read the entire 1,800-word essay here. I have also embedded the document down below in a Scribd reader.
Yesterday’s Supreme Court decision in Citizens United v. FEC essentially stands for the proposition that free speech is free speech regardless of the speaker. The 5-4 majority for the Court ruled that “We find no basis for the proposition that, in the context of political speech, the Government may impose restrictions on certain disfavored speakers. Both history and logic lead us to this conclusion.” (at 25) Echoing its early decision in Bellotti, the Court noted that “Political speech is ‘indispensable to decisionmaking in a democracy, and this is no less true because the speech comes from a corporation rather than an individual.’” (at 33) “All speakers, including individuals and the media, use money amassed from the economic marketplace to fund their speech. The First Amendment protects the resulting speech, even if it was enabled by economic transactions with persons or entities who disagree with the speaker’s ideas.” (at 35) “There is simply no support for the view that the First Amendment, as originally understood, would permit the suppression of political speech by media corporations.” (at 37)
Somehow this has proven controversial, even radical, to some. But, as George Will correctly notes, “This was radical only because after nearly four decades of such ‘reform’ the First Amendment has come to seem radical. Which, indeed, it is. The Supreme Court on Thursday restored First Amendment protection to the core speech that it was designed to protect — political speech.” Essentially, the decision gets Congress out of the game of picking who, or what platform, deserves full First Amendment protection when it comes to uttering political speech. And there’s nothing radical about that.
Indeed, as Justice Kennedy noted for the majority, there is nothing surprising about this reasoning once you realize that almost every other type legislative or regulatory speech restriction has been struck down as a violation of the First Amendment. “The law before us is an outright ban [on political speech], backed by criminal sanctions,” Kennedy noted (at 20). “If the First Amendment has any force, it prohibits Congress from fining or jailing citizens, or associations of citizens, for simply engaging in political speech.” (at 33) Think about this for a second: Criminal sanctions or jail time for political speech! How in the world did we get to the point in this nation where criminalizing political speech became acceptable to our legislators? Ignoring the obvious answer—it’s all about protecting incumbents—what is really “radical” here is not that the Supreme Court setting us back on the right path, but that our legislative branch has veered so far off of it.
Former NASA Administrator Mike Griffin used to refer to commercial alternatives to NASA’s Ares rockets as “Paper Rockets,” but commercial vehicles like Atlas V, Delta IV and Falcon 1 are quite real and available today, while Ares 1 and 5 are grossly over-budget and way behind-schedule:
http://www.youtube.com/v/VqR7IDzA5Xo
NASA should buy commercial space services whenever possible from NewSpace companies like SpaceX, Virgin Galactic and Bigelow Aerospace. The Commercial Spaceflight Revolution is happening now!
What Unites Advocates of Speech Controls & Privacy Regulation? [pdf]
by Adam Thierer & Berin Szoka
The Progress & Freedom Foundation,
Progress on Point No. 16.19
Anyone who has spent time following debates about speech and privacy regulation comes to recognize the striking parallels between these two policy arenas. In this paper we will highlight the common rhetoric, proposals, and tactics that unite these regulatory movements. Moreover, we will argue that, at root, what often animates calls for regulation of both speech and privacy are two remarkably elitist beliefs:
People are too ignorant (or simply too busy) to be trusted to make wise decisions for themselves (or their children); and/or,
All or most people share essentially the same values or concerns and, therefore, “community standards” should trump household (or individual) standards.
While our use of the term “elitism” may unduly offend some understandably sensitive to populist demagoguery, our aim here is not to launch a broadside against elitism as
Time magazine culture critic William H. Henry once defined it: “The willingness to assert unyieldingly that one idea, contribution or attainment is better than another.”[1] Rather, our aim here is to critique that elitism which rises to the level of political condescension and legal sanction. We attack not so much the beliefs of some leaders, activists, or intellectuals that they have a better idea of what it in the public’s best interest than the public itself does, but rather the imposition of those beliefs through coercive, top-down mandates.
That sort of elitism—elitism enforced by law—is often the objective of speech and privacy regulatory advocates. Our goal is to identify the common themes that unite these regulatory movements, explain why such political elitism is unwarranted, and make it clear how it threatens individual liberty as well as the future of free and open Internet. As an alternative to this elitist vision, we advocate an empowerment agenda: fostering an environment in which users have the tools and information they need to make decisions for themselves and their families. Continue reading →
The Technology Liberation Front is the tech policy blog dedicated to keeping politicians' hands off the 'net and everything else related to technology. Learn more about TLF →
The Technology Liberation Front is the tech policy blog dedicated to keeping politicians' hands off the 'net and everything else related to technology.