FDA Pressed to Change Regulations for Informed Consent

FDA_Pressed_to_Change_Informed_Consent_RegulationsA non-profit group is urging the U.S. Food and Drug Administration (FDA) to update its informed consent regulations. In a citizen’s petition, the Center for Responsible Science stated that patients are not fully informed that previous drug testing was only on animals, and that the extent to which the effects translate to humans is limited. The non-profit wants the FDA to update its regulations to mention animal testing when obtaining patients for clinical trials.

The citizen’s petition states that many drugs that “appeared safe in animal studies have resulted in severe adverse reactions and deaths when given to humans” even though animal models are used as “the gold standard during pre-clinical testing,” The group feels that the FDA is being too lenient with pharmaceutical companies by failing to mention this.

Under current FDA regulations concerning clinical trials, participants are informed about “any reasonably foreseeable risks and discomforts”. The citizen’s petition however, states that this leaves room for drug makers to avoid mentioning pre-clinical animal testing that “may not predict the degree to which the trial participants will be subjected” to risk.

The Center for Responsible Science cited an FDA report for 2004 to support its argument. That report found that a large majority of drugs that perform well during pre-clinical animal testing fail in clinical trials when tested in humans. Tools used to assess the safety of the product has also not changed in many years, the report noted.

The non-profit believes that failure to disclose such risks is unethical. CRS states that regulations concerning clinical trials should “mandate that [clinical trial] investigators make disclosures” to those participants. This should be “analogous to the disclosures patients would receive from their physician if the drug being tested was being prescribed.”

So far, there is no indication that the FDA will comply with the petition’s request. Last month, the agency acknowledged receipt of the petition in a letter filed on a government website.

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