|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 03-08-2007
New Generation of Stents Awaits FDA Approval
As the FDA and physicians debate the relative risks of drug coated stents vs. bare metal stents, companies are already developing a new generation of coated stents that try to overcome safety concerns associated with previous models. But the FDA may slow the approval of new models until more data is available on the older models.
Exactly what causes the clotting problem [with older models] isn't clear, but it is thought that either the design of the devices (which are tiny metal scaffolds), the polymer that holds and releases the drug, or the drug itself might prevent the body's healing response from completely covering the implanted stent with tissue. That could leave a portion of the stent's surface exposed to the blood stream, where it has the potential to trigger a clot. Whether the patient takes blood thinners and how accurately the physician implants the device may also play a role.
The FDA certainly has a conundrum on its hands. Newer models may be safer, but the agency is sensitive to criticism that it is rushing new drugs and devices to market without examining them sufficiently for potential safety problems. This in turn may be driving the agency to keep asking for more data on new designs, potentially keeping safer devices off of the market longer, and resulting in needless deaths.
A better approach would be to recalibrate how the FDA and industry weight pre-market vs. postmarket testing. Pre-market testing can never find all of the potential risks associated with new drugs and devices—and only offers the public the illusion of safety.
Instead, we should put promising new drugs and devices on the market faster, but require much more extensive post-market surveillance that would help physicians and patients use new innovations with greater safety and efficiency.
This is where we should be going but, if anything, safety scares from Vioxx and anti-depressant drugs seem to be pushing us in the opposite direction.
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