Posted by: Salvatore J. Zambri, Esquire
According to a Reuters article, reported by James Pethkoukis, experts have determined that the FDA’s approval process needs to be improved to better protect patients from dangerous risks.
At a congressional hearing, Representative Frank Pallone, who chairs a House Energy and Commerce subcommittee, stated, "There is evidence of an approval system that is broken — that its standards, its procedures and its rules don’t meet modern needs of getting medical devices to those in need with confidence in their safety." The article further comments that "Marcia Crosse, healthcare director for the nonpartisan Government Accountability Office, said various shortcomings ‘raise concerns’ about the FDA’s pre-approval reviews and post-approval monitoring ‘that are necessary for ensuring the safety and effectiveness of medical devices.’"
Although Americans benefit greatly from new products, the FDA must do more to protect those who will be using the products in the end–the patients. Without serious oversight, great harm can result.
Our firm has experience pursing cases for patients that involve tragic medication errors, pharmacy mix ups and unsafe medications. If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.
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