The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible

This article appeared in Pharmaceutical Compliance Monitor, October 3, 2014 and is reproduced with permission.

As the 2014 Ebola outbreak continues to spread in West Africa, drug companies, national governments, and public health entities as a whole are coming under increasing criticism for failing to offer what many would view as equitable approaches to addressing public health epidemics, particularly those occurring in poor or developing nations. Indeed, public health threats like the Ebola virus challenge drug companies to find the right balance between making unproven treatments available to desperate populations and ensuring the safety and efficacy of treatments that have yet to undergo comprehensive clinical testing. Furthermore, striking such a balance highlights a medical ethics issue that has haunted some of these drug companies in the past: conducting clinical trials on foreign populations with few of the ethical and safety protections required by western cultures, yet then pricing drugs out of the market for these same populations once they are FDA approved.

Foreign Data to Support U.S. Drug Marketing Approval
The Federal Food, Drug, and Cosmetic Act (FFDCA), which gives the FDA legal authority to oversee the safety and efficacy of drugs in the U.S., requires that several conditions be met before marketing approval can be granted. Among other requirements, 21 U.S.C. § 355(d) requires data showing that a new drug is safe for use under prescribed conditions and substantial evidence of efficacy as demonstrated through controlled clinical trials on human subjects. Clinical trials are normally conducted for multiple research phases that generally progress according to dosage and number of subjects (anywhere from a few participants to a few thousand participants) and are carried out at a large expense to the drug sponsor.

While legally conducting clinical trials on human subjects in the U.S. requires a drug maker to first obtain an Investigational New Drug (IND) designation from the FDA, 21 U.S.C. § 312.120(a) stipulates that the FDA can also "accept as support for an ... application for marketing approval ... a well-designed and well-conducted foreign clinical study not conducted under and IND," provided that the "study was conducted in accordance with good clinical practice (GCP)," and that the "FDA is able to validate the data from the study through onsite inspection if the agency deems it necessary." Drug companies may realize significant benefits from conducting clinical trials abroad, such as lower costs and faster study results. In fact, a report issued by the Department of Health and Human Services in 2010 indicated that approximately 40 — 65% of all clinical trials investigating FDA-regulated products are conducted outside of the U.S. One significant factor that has contributed to a shift of clinical trials to foreign countries is a loophole in FDA regulations that allows foreign clinical trial data to be considered for U.S. marketing approval even if U.S. clinical trials suggest that a drug has no benefit. In some cases, clinical trials may be carried out in countries where regulatory laws or weak or non-existent.

Please read "The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible" for the rest of this article.

If you have any questions about this article or would like to discuss this topic further, please contact the authors, Terry G. Mahn and Erin Knight, or your Fish attorney.