Drug Prices Likely to Rise With More Regulatory Oversight of Clinical Research Programs

Judith A. Waltz, JD, Diane Ung, JD, Mary Ellen Allen, JD

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In This Article

Introduction

As all PBMs are aware, the cost of drugs continues to rise. A significant contributor to increased drug prices is the cost associated with getting a drug to market. Today, on average, it takes $802 million -- compared with $231 million (in 1987 dollars) just a decade earlier -- and 14.2 years to develop a prescription drug and obtain FDA approval. The high costs and long time frames associated with drug development put pharmaceutical companies under tremendous pressure to fill development pipelines, control clinical trial costs, and deliver new and safe drugs to market, all while maintaining the integrity of clinical protocols and the safety of the human research participants. At the same time, the rise in private research funding arguably heightens the risk of conflicts of interest in clinical research that could compromise the role of institutional review boards (IRBs) in protecting human subjects.

The potential threat to human subjects has received particular attention. Phase III clinical trials, the last preapproval phase of drug testing, use large populations of afflicted patients to compare a new drug with standard therapy. This stage of drug development consumes the greatest percentage of research and development budgets. Meanwhile, many clinical trials are being delayed because there are not enough persons willing to participate. The shortage of volunteers can be attributed, in part, to public apprehension stemming from the recent well-publicized negative outcomes for participants in clinical trials. In June 2001, one well-known medical school hospital shocked the nation when it reported the death of a healthy 24-year-old research volunteer.

Mounting concerns about the ability of the current human subject protection systems to keep up with the dynamics and pressures of the medical research environment have fueled a sense of urgency to assess and strengthen those protections. In Congress, potential landmark legislation that would mandate additional protections for human research subjects is being considered. In the meantime, the Office of Inspector General (OIG) for the US Department of Health and Human Services (DHHS) has stepped up its monitoring and oversight of clinical research programs to ensure compliance with research and fiscal requirements.

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