Drugs

No Justification for Lack of Input on Informed Consent: Advocates

Public Citizen says there is no justification for FDA not seeking public input before issuing a final guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” In its comments, the advocacy group says FDA reported it had determined that prior public participation was not feasible or appropriate given that the “guidance presents a less burdensome policy that is consistent with public health.”

According to Public Citizen, the agency’s rationale is insufficient because it offered no examples of significant public health needs that were going unmet in the absence of final guidance on this topic. “We are not aware of any urgent public health needs that have gone unaddressed because IRBs could not waive the requirements to obtain informed consent,” the comment letter says. “It also would have been feasible for FDA to solicit public comment on a draft guidance document before issuing final guidance.”

Looking at the content of the guidance, Public Citizen expresses concern over the absence of any discussion of the ethical underpinnings of informed consent for human subjects research. “The fact that obtaining informed consent of human subjects may be burdensome for investigators does not outweigh the rights of research subjects to voluntarily agree to be enrolled in research,” the letter says, “even research that involves no more than minimal risk. We recommend that the guidance be revised to include a discussion of these ethical considerations.”

The group also expresses concern that the guidance fails to describe the types of clinical investigations for which the agency might consider an IRB’s waiver of informed consent to be appropriate. “For example,” it says, “does the agency believe that the waiver of informed consent would be appropriate from both an ethical and regulatory perspective for clinical trials testing investigational new drugs or medical devices and, if so, under what circumstances would that be the case?”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome