Clinical Drug Testing: Will Reform Equal Delay?

Clinical Drug Testing: Will Reform Equal Delay?

June 11, 1998

Washington, DC, June 11, 1998 — Reports released today by the Department of Health and Human Services (HHS) vastly overstate the need for new federal rules governing Institutional Review Board oversight of clinical trials, the Competitive Enterprise Institute stated today. "The proposed changes won’t improve safety," said CEI policy analyst Gregory Conko, "but they could delay the availability of potentially life-saving medical therapies."

Institutional Review Boards (IRBs) are committees of medical experts and laymen established by research institutions to ensure the proper selection and treatment of human subjects in clinical trials. The four reports, presented to the House Government Reform and Oversight Committee’s Human Resources subcommittee this morning, argue that "IRBs’ limited efforts in conducting review of active research is a serious national issue because it compromises their protection of human subjects." Yet the reports also acknowledge that there is no tangible evidence suggesting that problems with human research subjects are more than isolated anomalies.

Among its proposals, HHS recommends that Institutional Review Boards be required to assume greater responsibility for supervising the operation of research sites, and that the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) increase their oversight of IRBs. However, in any clinical trial there already are at least six different individuals or groups responsible for protecting patients. "There is no reason to believe that the new requirements would provide any more protection for patients than existing federal enforcement and private remedies," said Conko.

In a new book on drug development, Policy Controversy in Biotechnology, Henry I. Miller, M.D., Senior Research Fellow at Stanford University’s Hoover Institution and a former FDA official, points out that the last time HHS moved to protect the interests of test subjects, the "unnecessarily burdensome" regulations made the drug development process "slower and more expensive."

Currently, it takes an average of nearly ten years to develop a new drug and navigate the FDA approval process. In polls conducted by CEI, 65 percent of cardiologists and 77 percent of oncologists agreed that the FDA approval process for drugs and devices is too slow. Requiring increased supervision of researchers is likely to extend even further the time it takes to get new drugs and devices to market.

CEI is a non-profit, non-partisan research and advocacy institute dedicated to the principles of free markets and limited government. For more information, contact Emily McGee at 202-331-1010.