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Regulatory News | 09 December 2014 | By Alexander Gaffney, RAC
President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls.
The issue of placebo controls has been a contentious one to regulators and ethicists around the globe.
At issue: Since Ebola has such a high rate of mortality, should all patients have access to investigational drugs if they are available? Or should regulators insist on the use of placebos—even standard-of-care placebos—in order to ensure that investigational drugs are safe, effective and ready for future outbreaks?
In the US, FDA has repeatedly made the case that it wants sponsors of investigational Ebola products to test their products against a "best available supportive care" placebo.
"The desire to allow all patients access to investigational drugs is understandable," FDA regulators wrote in a recent op-ed in the New England Journal of Medicine, "but there are strong reasons to doubt the ability of such 'historically controlled' studies to distinguish effective therapies from ineffective ones."
"If historical comparisons falsely suggest a benefit or fail to detect modest but meaningful clinical effectiveness, the investigational drug might be erroneously adopted as effective or discarded as ineffective," they wrote.
For further insight into FDA's views on placebo controls, please see their NEJM op-ed here, or an interview at the Forbes Healthcare Summithere.
Now federal ethicists are slated to weigh in as well. In a Federal Register announcement on 8 December 2014, the Presidential Commission for the Study of Bioethical Issues (PCSBI) said it is collecting public comments on the country's response to Ebola.
The commission said it is currently considering several "areas of ethical concern" raised by a recent outbreak of Ebola in West Africa and a handful of cases in the US.
Among those concerns are two of note to regulators and regulatory professionals: whether the use of placebo-controlled clinical trials in an emergency is ethical, and whether it is ethical to collect and store biospecimens for use in future research.
The commission said it is interested in receiving public feedback on both questions, including whether it would be possible to develop standards for ethical behavior in both circumstances.
Comments are due to the commission by 6 February 2015.
Federal Register Notice
Tags: Ebola, Ethics, Presidential Commission for the Study of Bioethical Issues