6A proposal to curtail governmental review of medical devices is the latest issue to delay Senate legislation to overhaul the Food and Drug Administration.
Sen. Jim Jeffords (R-Vt.), said the provision would bring a “much-needed element of due process” to product reviews.
Sen. Edward Kennedy (D-Mass.) is holding up the bill because of the proposal. Kennedy said Friday the “disgraceful provision” would jeopardize Americans’ health and safety.
Under Jeffords’ provision, the FDA couldn’t check the safety and effectiveness of medical devices for uses the manufacturer hasn’t listed on the label. Kennedy said that means the agency couldn’t request more data from manufacturers who pass a product off as being for one purpose when the design suggests it will be put to a completely different use.
