Now-Mandatory Informed Consent Wording Won't Be Required Retroactively
Executive Summary
Study investigators will not have to retroactively "re-consent" clinical trial participants who have not signed on to a soon-to-be-mandatory version of informed consent forms that states that information about the trial will be posted on ClinicalTrials.gov.
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Electro-shock controversy: Psychiatrists and skeptic patient advocacy groups remain split on the safety and efficacy of electroconvulsive shock therapy devices. After requiring manufacturers of certain "pre-amendment" Class III devices, including ECT devices, to submit safety and effectiveness information, FDA opened a docket to allow the public to weigh in as the agency decides whether to require PMAs for the devices or downclassify them (1"The Gray Sheet" Sept. 14, 2009). The psychiatric community maintains that ECT is a safe and effective treatment option for psychiatric disorders such as severe depression. "When patients are appropriately screened and ECT is appropriately delivered, there is no question about its efficacy in a significant percentage of very ill patients," Cleveland Clinic's Donald Malone, M.D., comments. "Requiring a PMA of the current ECT device companies would place a tremendous burden on relatively small companies." Others, such as the Center for Disability Rights, oppose down-regulation. Because of the "severe danger" of electro-shock, the procedure is banned in Texas for children under age 16, noted one psychologist who urged FDA to require PMAs for ECT devices. Though not a booming market, ECT is still used in some facilities; manufacturers include Mecta Corporation (SpECTrum) and Somatics (Thymatron)
Clinical Trial Certification Requirements Under FDAAA May Be “Time Bomb”
The section of the FDA Amendments Act that requires companies to post information about their clinical trials contains a "hidden time bomb," according to I. Scott Bass, a partner at the law firm Sidley Austin
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Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.