56 Pages Posted: 21 Jul 2012
Date Written: July 20, 2012
In the Food and Drug Administration Amendments Act of 2007 (FDAAA), Congress enacted what some scholars have described as the most significant revisions to federal drug regulations in more than fifty years. In particular, the FDAAA provided the U.S. Food and Drug Administration (FDA) with substantially expanded authority and control over postmarketing surveillance of FDA-approved medications. FDA can now require pharmaceutical manufacturers to conduct — and condition continued marketing approval on successful completion of — additional clinical trials following postmarketing detection of unlabeled adverse events, and can compel manufacturers to update drug labeling to reflect newly discovered health risks; powers that, before 2007, inexplicably had been absent from FDA’s regulatory toolbox. Most significantly, the act mandated that FDA develop a single, comprehensive, and searchable electronic data network (the “Sentinel System”) comprising, by July 1, 2012, health care data from public and private sources for at least 100 million patients. Through this network, FDA will for the first time in history be able to actively query patient health care data to assess during the postmarketing period potential health risks associated with FDA-approved drugs that went undetected during clinical development.
What the FDAAA and the Sentinel System do not do, however, is sufficiently protect those who make possible this early detection of unlabeled adverse events: specifically, those patients who are prescribed medications immediately following their approval (whom this Article will term “first subscribers”), when many potential risks remain unknown. As significant as the Sentinel System is — and it is revelatory both in the breadth of its scope, and in the fact that it took Congress until 2007 to require of FDA — its success is premised on the fact that these first subscribers to a newly approved medication necessarily will suffer from one or more unlabeled adverse events during the postmarketing period. This group of patients ostensibly serves as a de facto clinical trial for the medication at issue, but without the disclosures and protections afforded actual, willing trial participants. Rather than forcing these patients to rely on the unpredictability of tort litigation for relief (assuming it is even available), or burdening an already stretched-thin health insurance network, this Article proposes the adoption of a no-fault compensation scheme for these first subscribers to cover health care expenses attributable to injury resulting from unlabeled adverse drug events. Taking its cue from the National Vaccine Injury Compensation Program, and analogous to numerous other domestic and foreign administrative claims funds directed to product-specific injuries, this Article proposes that this system be funded entirely by the pharmaceutical industry as a condition of marketing approval for all new drug applications.
With the FDAAA approaching its five-year anniversary in September 2012, and with it the Sentinel System approaching its intended functional capacity, the time is now to implement this alternative compensation scheme to speed relief to those who will make possible the warnings that will protect future prescription drug users.
Keywords: Food and Drug Administration, FDA, FDAAA, Sentinel, Affordable Care Act, Health Care and Education Reconciliation Act, ACA, PPACA, HCERA, healthcare, health care, prescription, drug, pharmaceutical, postmarketing
JEL Classification: H51, I11, I18, K00, K13, K32
Suggested Citation: Suggested Citation
Miller, Rodney Kristopher, Sacrificial Lambs: Compensating First Subscribers to FDA-Approved Medications for Postmarketing Injuries Resulting from Unlabeled Adverse Events (July 20, 2012). Catholic University Law Review, Vol. 62, No. 2, Forthcoming. Available at SSRN: https://ssrn.com/abstract=2114394