[OA] Dangerous Times: The FDA’s Role in Information Production, Past and Future
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.1 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.2
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.3
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.4
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.5 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.
We need the FDA to play this role because it is, quite simply, extraordinarily hard to know whether something is or is not a cure. By controlling marketing, the FDA targets a distortion inherent to systems that rely on the profit motive and patents to generate clinical trial data: it encourages the creation of high quality evidence about medicines that is not biased toward positive results. (By “positive” I mean results that appear to favor the safety or efficacy of the drug.) Critically, the Agency also validates evidence about medicines—an activity that is more intensive than what is implied by the term certification.
Evaluating the qualities of drugs, as I will describe, has very little in common with rating hotel rooms or warrantying used cars. A typical FDA new drug review involves hundreds of thousands of pages of data, and may require reviewers to rerun data analyses, to query companies for more information, and to closely scrutinize individual trial records. Validation of the results of drug trials requires significant expertise, significant resources, and access to all of the relevant clinical trial data. While markets sometimes produce viable third-party certifiers, they cannot produce adequate third-party validators, absent major interventions that effectively turn third parties into smaller, independent versions of regulatory agencies.
In the pages that follow, I first aim briefly to explain these claims in more detail and show that the most persuasive justification for the FDA’s modern regulatory approach stems from the enormous challenges associated with producing and validating high-quality information about medicines. The point is underappreciated both in the academic literature and in policy debates, and is critical to understanding the problems with the recent challenges to the FDA’s drug regulatory authority that are sketched above. Such changes might bring compounds more quickly to patients. But they also plausibly could bring about a world where we know less and less about the medicines we put in our bodies.
Understanding the FDA’s information production role, I’ll show, allows us to see more clearly the danger of immensely popular right-to-try laws. It also helps highlight the grave dangers of emerging First Amendment law that asks judges rather than regulators to determine what is true about a drug. Finally, the information production lens also clarifies the stakes of the FDA’s implementation of the 21st Century Cures Act.
In particular, it makes plain that the implementation of that Act must be preceded by a much more complete account of the reliability of regulatory decisions made on accelerated timelines and with less evidence. Any move to lower regulatory standards should also be avoided until we have a better understanding of why postmarketing study requirements are so rarely fulfilled in a timely fashion, and until FDA has the resources and authority needed to alter this fact.
Kapczynski A. Dangerous Times: The FDA’s Role in Information Production, Past and Future. Minnesota Law Review. 2018;102(6). http://www.minnesotalawreview.org/wp-content/uploads/2018/07/Kapczynski_MLR-1.pdf
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.1 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.2
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.3
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.4
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.5 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.
We need the FDA to play this role because it is, quite simply, extraordinarily hard to know whether something is or is not a cure. By controlling marketing, the FDA targets a distortion inherent to systems that rely on the profit motive and patents to generate clinical trial data: it encourages the creation of high quality evidence about medicines that is not biased toward positive results. (By “positive” I mean results that appear to favor the safety or efficacy of the drug.) Critically, the Agency also validates evidence about medicines—an activity that is more intensive than what is implied by the term certification.
Evaluating the qualities of drugs, as I will describe, has very little in common with rating hotel rooms or warrantying used cars. A typical FDA new drug review involves hundreds of thousands of pages of data, and may require reviewers to rerun data analyses, to query companies for more information, and to closely scrutinize individual trial records. Validation of the results of drug trials requires significant expertise, significant resources, and access to all of the relevant clinical trial data. While markets sometimes produce viable third-party certifiers, they cannot produce adequate third-party validators, absent major interventions that effectively turn third parties into smaller, independent versions of regulatory agencies.
In the pages that follow, I first aim briefly to explain these claims in more detail and show that the most persuasive justification for the FDA’s modern regulatory approach stems from the enormous challenges associated with producing and validating high-quality information about medicines. The point is underappreciated both in the academic literature and in policy debates, and is critical to understanding the problems with the recent challenges to the FDA’s drug regulatory authority that are sketched above. Such changes might bring compounds more quickly to patients. But they also plausibly could bring about a world where we know less and less about the medicines we put in our bodies.
Understanding the FDA’s information production role, I’ll show, allows us to see more clearly the danger of immensely popular right-to-try laws. It also helps highlight the grave dangers of emerging First Amendment law that asks judges rather than regulators to determine what is true about a drug. Finally, the information production lens also clarifies the stakes of the FDA’s implementation of the 21st Century Cures Act.
In particular, it makes plain that the implementation of that Act must be preceded by a much more complete account of the reliability of regulatory decisions made on accelerated timelines and with less evidence. Any move to lower regulatory standards should also be avoided until we have a better understanding of why postmarketing study requirements are so rarely fulfilled in a timely fashion, and until FDA has the resources and authority needed to alter this fact.
Kapczynski A. Dangerous Times: The FDA’s Role in Information Production, Past and Future. Minnesota Law Review. 2018;102(6). http://www.minnesotalawreview.org/wp-content/uploads/2018/07/Kapczynski_MLR-1.pdf
