MASSDEVICE ON CALL —The Medical Device Patient Safety Act, introduced this week in the Senate, calls for increased safety measures for device approval from the FDA.
The bill, introduced by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
The bill would also strengthen the rules for the FDA’s 510(k) protocol, which currently only requires device makers to show that their products are similar to those already-cleared devices.
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Med-tech lobby AdvaMed issued a statement opposing the bill, insisting that the FDA needs a clearer recall process rather than more regulation.
"It is important for the America public to realize that the medical technology industry has a well-documented safety record," Janet Trunzo, executive vice president of AdvaMed said prepared remarks, noting that less that 0.5% of all devices cleared by the FDA are involved in a serious recall.
"We believe expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k)," said Trunzo.
The bill was sparked by a slew of high-profile lawsuits against medical device goliaths Johnson & Johnson (NYSE:JNJ), C.R. Bard Inc. (NYSE:BCR), American Medical Systems Holdings Inc. (NSDQ:AMMD) and Boston Scientific Corp. (NYSE:BSX) for transvaginal mesh devices that may do more harm than good.
Add to that the high-profile metal-on-metal hip implant recalls by J&J subsidiary DePuy Orthopaedics, which has spawned its own raft of lawsuits. Analysts have estimated that settlement of those cases could cost JNJ up to $1 billion.
Another high-profile case involves Medtronic Inc.’s (NYSE:MDT) 2007 Sprint Fidelis recall, which was implicated in more than 100 deaths (Medtronic has said that only 13 fatalities had the leads as a "possible or likely contributing factor"). The various transvaginal mesh products, DePuy’s hip implants and Medtronic’s Sprint Fidelis were all cleared through the FDA’s 510(k) device review fast-track.
"Our mission is to protect the public health," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health said in a meeting with investors yesterday. "But it’s also to promote public health by promoting innovation. There’s this misperception out there that the two are inconsistent but we think they are very compatible."
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