U.S. regulators should be able to block medical devices based on past products with safety issues, said House Democrats, citing injuries from transvaginal implants like those made by Johnson & Johnson and C.R. Bard Inc. (BCR)
A bill introduced this week would close a loophole that lets devices win approval even when they’re similar to a product already pulled from the market, the Democratic lawmakers, led by Representative Edward Markey of Massachusetts, said in a statement yesterday.
Vaginal implants spurred a Food and Drug Administration alert last year amid patient complaints of pain and internal injuries. The devices were cleared by the agency’s 510(k) system, which allowed them to be sold without human testing once the FDA rules they are similar to existing products. In October, Bloomberg News reported many implants trace their approvals to a Boston Scientific (BSX) Corp. mesh recalled for safety issues in 1999.
“If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” Markey said in the statement. The bill ensures “that devices do not mimic the mistakes made by other products.”
Manufacturers “share Congressman Markey’s interest in ensuring the safety and effectiveness of medical devices,” said Wanda Moebius, a spokeswoman for the Advanced Medical Technology Association, an industry trade group in Washington, in an e- mail. “However, we believe FDA already has abundant authority to carry out its mandate and the burdensome provisions” in the bill “will not contribute to patient safety.”
To become law, the legislation, HR3847, would need to pass the Republican-controlled House and Democratic-led Senate and then win President Barack Obama’s signature. Debbee Keller, a spokeswoman for the Republican majority on the House Energy and Commerce Committee, which has been holding hearings on medical device rules, didn’t return an e-mail seeking comment.
Current law requires the FDA to clear a device for sale if it’s “substantially equivalent” to a past device, known as a predicate. Markey’s bill would let the agency say no if the predicate, or past predicates in a series of equivalent devices, were removed from the market or if the agency were in the process of pulling it. It also would require companies to explain why their products are different from recalled versions
The legislation also requires the FDA to review previously cleared products to determine whether any have recalls in their “device lineage.” A report would be due to Congress within three years.
Vaginal meshes were implanted in about 300,000 women a year to shore up pelvic muscles or treat incontinence. The FDA last month ordered more safety studies from manufacturers, a group led by J&J; C.R. Bard; and Boston Scientific, of Natick, Massachusetts.
Johnson, the J&J spokesman, said in a statement last month that the company’s meshes were already among “the most-studied devices on the market” and J&J would continue to conduct tests to prove their worth to patients.
Markey’s bill is one of more than a dozen introduced in Congress to overhaul device reviews, in response to consumer advocates who say products need to be safer and industry groups who say the process is too strict.
U.S. Senators Bob Casey and John McCain introduced a bill today that they said would streamline approvals. The legislation would ease the “burdensome review” the FDA requires to see if a new product is similar to one already on the market, the two men said in a statement.
“The FDA’s current approval process for medical devices can be cumbersome, inconsistent and far too lengthy for patients who need innovative technologies and for the companies that develop them,‘‘ said McCain, an Arizona Republican. Casey, a Democrat, is from Pennsylvania.
The bill would also address safety issues by ensuring that medical devices on the market before current safety rules existed are properly classified in a timely manner, according to the statement.
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