The Food and Drug Administration approves medical products, supposedly to protect consumers. As proved by a Congressional committee, anyone can get anything approved.
Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies.
People may assume the IRBs are well-regulated. On the contrary, IRBs are a sham.
About 6,350 IRBs are registered with the Department of Health and Human Services.
Fake products and fake IRBs.
Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.
The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.
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