In his last State of the Union address, Barack Obama asked, “How do we make technology work for us and not against us?” This was one of Obama’s four “big questions” during his speech, and the audience cheered as he asked it—for good reason. It echoes the fears of regulators everywhere.
These fears are thoroughly and mostly honestly addressed in FDA in the 21st Century. As the title suggests, the emergence of new drugs and technologies has been disconcerting for the U.S. Food and Drug Administration. The rapid-fire pace of medical progress in the 21st century, particularly the remarkable strides made in personalized medicine, has called into question the FDA’s purpose in the regulatory universe.
The list of contributors here is telling: It is written mainly by lawyers, with a smattering of Ph.D.s and just four M.D.s (two of whom are also a lawyer and a Ph.D., respectively). This book is the result of a 2013 symposium at Harvard Law School, and it shows: It is primarily written for, and about, the interests of regulators. Physicians, patients, and drug developers are rarely heard from in the 500-plus pages spent discussing medical policies.
Despite the lopsided representation, however, the authors do a good job of describing pressing legal and technical problems facing the FDA, and the book contains thoughtful, scholarly discussions. Perhaps the most important section is Part Three, “Protecting the Public Within Constitutional Limits.” To the editors’ credit, it contains a compelling debate on an extremely contentious issue that goes to the heart of the FDA’s constitutionality: the right to promote drugs for “off-label,” or non-FDA-approved, uses. It also offers a fascinating legal analysis from Christopher Robertson in his essay, “The FDCA as the Test for Truth of Promotional Claims.”
The promotional claims Robertson refers to are those of Alfred Caronia, a pharmaceutical sales representative who was convicted of promoting drugs for off-label use in 2009. Caronia appealed his conviction, and in 2012, the Second Circuit Court of Appeals ruled that the FDA may not prohibit “the truthful off-label promotion of FDA-approved prescription drugs.” Caronia’s conviction was overturned.
This matters because, as Robertson argues, what is the FDA the arbiter of, if not truth? Who is to determine whether a drug promotion is truthful, if not the FDA? This line of reasoning demonstrates the gulf that exists between medical professionals, who are in a position to observe and understand the effects of medicine in their daily work and who want to provide effective treatment to patients and lawyers viewing medicine from a distance. Doctors do not care who determines truth, as long as it is true.
In contrast to Robertson, Coleen Klasmeier and Martin H. Redish (also lawyers) side with the medical community, arguing that the FDA does not “own” the truth. In their piece they make the case that the medical community serves as a free market for truth and point out that the off-label use of drugs is “accepted medical practice.” In this way, Klasmeier and Redish provide an intelligent and effective defense of the First Amendment—and of reality.
All the authors seem to agree, however, that the Caronia case left the FDA in a potentially awkward position. As R. Alta Charo notes in her essay, the “court narrowly avoided overturning the entire structure of the drug regulatory system.” She expresses concern that the reduced value of the FDA’s testing might lead to “narrower approval trials [which] result in wide population use beyond the label.” As it turns out, many patients and physicians would be thrilled with this outcome.
In their introduction, the editors admit that a well-informed, impatient populace has been challenging for the FDA. In another chapter, Charo acknowledges that, since the 1960s, the FDA has prided itself on a slow-moving, cautious approach. Ill people, however, are less inclined to wait than ever before. That is partly why it is in the FDA’s interests to limit patient access to knowledge about drugs by preventing pharmaceutical representatives from disseminating truthful information about potential treatments. The Caronia case was a blow indeed.
The FDA has faced many challenges in a remarkably productive (medically speaking) 16 years. Technology has mostly worked against the agency, and its attempts to enforce control over the medical field have begun to falter. FDA in the 21st Century does an excellent job of highlighting and explaining these issues, and it is a useful source for anyone interested in the nexus of modern medical bureaucracy. It offers fewer answers than questions, which is good news for those who would like to see continued medical progress.
Devorah Goldman is senior health care analyst at Capital Policy Analytics, a consulting firm in Washington.
