Summary

Original source:
http://www.boston.com/business/articles/2004/12/24/22_of_medical_device_follow_up_studies_left_undone/

Details

• Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior regulator who has launched a campaign to improve the ratio.
• At a time when the FDA is under fire for its oversight of drugs like Vioxx and Celebrex, which prompted health concerns after they were approved, Schultz's comments show how companies that make products such as pacemakers and hearing aids can also expect more scrutiny.
• Since Schultz has been pressing for more follow-up studies for over a year, his plans to improve the situation through public disclosure or bureaucratic reforms could be a model for the way the FDA treats drug companies in the future.
• Post-approval studies are routine in theory and rare in practice, an open secret in the healthcare industry.
• The issue wasn't as great in the past when devices were introduced to the market more slowly than drugs, giving producers time to make small changes.
• But now big marketing campaigns mean thousands of people might begin a treatment like an artificial hip or pacemaker within weeks of its approval.
• Earlier this year, for instance, Boston Scientific Corp. had to take 165,000 new drug-coated cardiac-stent systems out of inventory after a manufacturing flaw was linked to three deaths and more than 40 injuries.
• In 2003 the FDA notified doctors that a similar product from Johnson & Johnson was linked to more than 60 deaths, though the agency later determined the death rate was within an expected range.
• Citing those examples, Schultz said in an interview after his speech to the Massachusetts Medical Device Industry Council that "When you have such incredible market penetration in such a short time, we need to make sure we're asking a lot of questions about both products early in the process."

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