Grassley Raises Concerns About Safety of Medical Devices in Letter to Crawford

Main Category: Medical Devices / Diagnostics
Article Date: 21 Jul 2005 - 14:00 PDT

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Senate Finance Committee Chair Chuck Grassley (R-Iowa) on Monday sent a letter to... FDA Commissioner Lester Crawford over concerns about agency efforts to ensure the safety of medical devices, CQ HealthBeat reports. Grassley recently has raised concerns about how FDA has addressed a "wide range of device safety issues," CQ HealthBeat reports. In the letter, Grassley cited recent safety issues related to implantable defibrillators and pacemakers manufactured by Guidant, as well as subsequent product recalls, and asked why FDA does not make public all annual reports on product failures and patient deaths submitted by defibrillator and pacemaker manufacturers. Grassley also asked Crawford to explain the FDA policy on public disclosure of annual safety reports on other medical devices. Grassley wrote that Crawford has until July 22 to respond. According to Grassley, a study on medical device safety released earlier this week by the Institute of Medicine "documents how the FDA is neither properly monitoring postmarket studies nor making important postmarket research available to the public." Grassley added, "These are the same kinds of problems we see with the postmarket review of medicines." The report also raises concerns about the safety of medical devices for children, Grassley said.

Other Concerns
Grassley and Sen. Max Baucus (D-Mont.), ranking member of the Senate Finance Committee, also have raised concerns about the FDA approval process for medical devices. The committee has begun an investigation of the decision by FDA earlier this month to approve the vagus nerve stimulator as a treatment for chronic depression after the agency last year denied approval. Recent comments from Grassley and Baucus indicate that the committee "is moving decidedly beyond the issue of prescription drug safety" and will have an "emerging role as an aggressive overseer" of medical device safety, CQ HealthBeat reports. However, a medical device industry attorney said, "Unless there is someone who really keeps the heat on, things don't happen," adding, "I don't think Republicans are very good at following through" on FDA safety issues (CQ HealthBeat, 7/19).

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