15 December 2018

FDA, personhood and corporate speech

' The Lochnerized First Amendment and the FDA: Toward A More Democratic Political Economy' by Amy Kapczynski  in (2018) 118(7)  Columbia Law Review comments
“[T]he majority has chosen the winners by turning the First Amendment into a sword, and using it against workaday economic and regulatory policy. Today is not the first time the Court has wielded the First Amendment in such an aggressive way. And it threatens not to be the last. Speech is everywhere—a part of every human activity (employ­ment, health care, securities trading, you name it). For that reason, almost all economic and regulatory policy affects or touches speech. So the majority’s road runs long. And at every stop are black-robed rulers overriding citizens’ choices. The First Amendment was meant for better things.” Janus v. AFSCME, Justice Kagan, dissenting
The “Lochnerization” of the First Amendment is without a doubt one of the most important developments in constitutional law in recent years. This was so before the explosive end of the 2018 Term, and it is particularly evident after it.  As Justice Kagan laid bare on the same fate­ful day that Justice Kennedy announced his retirement, recent Supreme Court decisions have “weaponiz[ed]” the First Amendment, turning it into a powerful tool against a range of ordinary socioeconomic legisla­tion. There is little that can escape its reach, because we are crea­tures of speech, and governance and speech are inescapably intertwined. 
There may be no edifice of public regulatory power more immedi­ately threatened by this trend than the Food and Drug Administration (FDA). A key accomplishment of both the Progressive Era and the New Deal, the FDA is perhaps the most muscular of all federal agencies, and a key American instance of public power over market imperatives. It also has enjoyed extraordinarily high levels of influence and public trust throughout its long history.
Like many agencies, the FDA governs a great deal that is readily understood as speech, such as disclosures on food labels, warnings for tobacco, and advertisements for medicines and cosmetics.  But the core of its regulatory power runs much deeper and may seem far less obvi­ously susceptible to the acid bath of contemporary free speech law. For example, the FDA is a gatekeeper for new pharmaceuticals, forbidding any person from “introduc[ing] into interstate commerce” any unap­proved drug. This sounds like it constructs governmental power over conduct and products, and it does. But it also can be construed as con­straining speech. An introduction for sale, after all, is often accom­plished through nothing more than speech, such as an offer for sale or advertise­ment. A “drug” is, by law, anything “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”  Intended use is commonly construed via speech, such as advertisements or labels that suggest a particular use. A company may market furniture oil as a cleaning product. But if it markets it as a remedy for cancer, the same substance becomes a “drug” for purposes of the FDA. The FDA is a critical and revealing example, then, of the astonishingly broad reach of a weapon­ized First Amendment. 
As commercial speech protections have expanded, they have, in fact, begun markedly to encroach upon the FDA’s powers. Courts, speaking in the name of the First Amendment, are “freeing” us from regulatory approaches that have worked for decades to inform us about the prod­ucts we put in our bodies. How did we arrive here? And how might demo­cratic prerogatives over the webs of commodity exchange upon which our lives today depend be rebuilt, particularly if the Court continues down its current path? 
Part I offers a brief overview of the FDA. It traces the arc of the Agency’s construction in order to illuminate the importance of its work and to show the threat posed by recent First Amendment cases, particu­larly to the Agency’s oversight of drug and tobacco markets. 
Part II explores how the First Amendment, long understood as a protector of democracy, has come to pose a threat to democratic author­ity over markets. Using several landmark commercial speech cases, I show that commercial speech protection today is built upon certain distinctive and contestable conceptions of the nature of markets, states, and sub­jects. Markets are cast as neutral domains that must be kept free from democratic interference; the state is suspect and the locus of capture rather than democratic will-formation; and subjects have unitary “inter­ests” that allow no firm distinction between the realm of the political and the realm of the market. These ideas are not plucked from thin air. They are important components of the kind of market fundamentalist thought that gained prominence in the United States in the 1980s and thereafter, as has been elaborated in the literature on neoliberalism. The analysis here complements Professor Jed Purdy’s Beyond the Bosses’ Constitution and simi­larly contributes to the emerging “law and political economy” litera­ture. Law and political economy approaches are grounded in the premise that the economy and political life are not fully separable but mutually shape and influence one another.  Law constructs markets, and the distribution of economic power (and “private” power more broadly) deeply shapes law. Political economy analysis seeks to illuminate this fact and to map the relationship between markets and political life as it is figured across a wide range of legal domains.
Scholars elaborating political economy approaches to law also tend to engage a further question, one resonant with the aims of this Symposium: What new theories and institutions do we need to sustain and create a more genuinely democratic and equal society? Part III addresses this question as it appears in the FDA context. It shows that there is room within current doctrine to revive robust regulatory author­ity for the Agency. It also maps another way to rescue democratic pre­rogatives if courts continue down their current path: a pivot away from the model of private market regulation upon which the FDA’s approach is built. 
If courts thrust us into a world with more limited authority over pri­vate markets, we must envision a much more substantial role for the public—in this case, for example, by expanding public funding for health research. This approach could mitigate the harm done by recent court decisions and have far-reaching benefits for what we might call health democracy or health justice. It is also an instance of a broader point: As a commit­ment to market supremacy advances inside of constitutional doctrine, democratic control over our economy and society will demand new pub­lic infrastructure that displaces or routes around an increasingly ungov­ernable private sector. ... 
Though beyond the ambition of this short contribution, an explora­tion of the political economy of current commercial speech law must eventually lead us also to reconsider its scope. Courts have long been confused about why our Constitution might protect speech acts in the marketplace. Current law reasons increasingly in a market-supremacist idiom, suggesting, outlandishly, that the First Amendment exists to pro­tect market order from democratic governance. Protections for commer­cial speech must serve rather than subvert our democracy. Delineating a new political economy of the First Amendment that helps achieve this aim is an important task for those who seek a future that is more demo­cratic and equal than our present.