Dangerous Times: The FDA's Role in Information Production, Past and Future

Abstract

These are challenging times for the Food and Drug Administration. Congress passed a so-called right-to-try law in May 2018, sharply limiting the Agency's oversight of the use of experimental drugs. Nearly the only thing the lame duck Congress could agree upon in 2016 was that the FDA should lower its regulatory standards to speed drugs to market. The resulting 21st Century Cures Act urges the Agency to approve drugs with less evidence, but gives the Agency no significant new tools to ensure that companies produce adequate data after a drug enters the market. The Agency also faces profound challenges in the courts. Drug companies have successfully leveraged recent developments in commercial free speech doctrine to call into question the constitutionality of the Agency's restrictions on drug marketing, particularly regarding unapproved (off-label) uses of approved drugs.

Proponents argue that these developments will yield better, faster access to cures. For the most part, these proposed changes are instead likely to put patients in danger and lead to wasteful spending. To understand why, we first need a shared understanding of the central purpose of the FDA's regulation of drug marketing. That mission is commonly described as paternalistic in nature: via pre-market review, the FDA protects us from unsafe medicines. Another prominent view asserts that the justification for the FDA's regulatory power comes from information asymmetries between consumers and companies: by certifying the quality of medicines, the FDA helps consumers make good choices. Both of these arguments have come under sustained attack recently, the first from certain patients' groups and conservative advocacy groups that object to the paternalism it implies, and the second from scholars and advocates who believe that decentralized certification would be more efficient.

Neither of these two visions provides the best justification for the FDA's regulatory power over the marketing of medicines. As Rebecca Eisenberg has suggested, the FDA in its modern form aims primarily to address a problem of information production. The core function of the FDA as a drug regulator, as I will elaborate below, is not to make choices for the public, or to certify the truth, but to generate and validate information about medicines.