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WASHINGTON, Jul 27, 2005 (United Press International via COMTEX) -- Smaller medical-device firms are hoping Congress will pass -- before its August recess -- a bill intended to reduce their development costs for new products, but some consumer advocates said the legislation should focus on safety.
Last week the Senate Health, Education, Labor and Pensions Committee approved the Medical Device User Fee Stabilization Act of 2005, or MDUFSA, which increases the revenue cap that defines a small business to $100 million from the existing cap of $30 million.
If passed into law, firms of that size or smaller will be able to pay a reduced amount to file a new-product application to the U.S. Food and Drug Administration. The bill also requires the FDA to limit its annual fee increase for applications by medical-device firms for timely review and approval of their products.
Under FDA regulations, a device manufacturer must obtain pre-market approval before it can begin selling a new medical device. Applicants also must provide evidence the new devices are safe and their manufacture will conform to government standards.
Next year the application fee for a novel device will increase to $259,600, but under MDUFSA the cost would drop to $98,650 for companies with annual sales revenues of $100 million or less.
Mark Leahey, executive director of the Medical Device Manufacturers Association in Washington, told United Press International much of the innovative technology in the medical-device sector comes from smaller firms. MDUFSA would ensure that the medical-device sector will not begin to resemble the pharmaceutical industry, in which "only ... a limited number of companies ... can afford the process," he added.
With many new and emerging firms, "the company begins with a doctor and an engineer working to create a better product for the patient," said Leahey, whose trade group represents many new and small entrepreneurs in the medical-device industry.
MDUFSA also ensures that mom-and-pop firms will not "fall by the wayside" because of high regulatory costs, Leahey said, explaining that the bill does not impact FDA oversight of small firms.
The legislation not only fosters "an entrepreneurial sprit" within the medical-device community, but also creates an equal playing field for smaller firms, he noted. "The best technology comes from a competitive marketplace."
Some consumer advocates argue, however, that lawmakers should amend the bill or enact new legislation to include tougher evaluation standards for medical devices.
Last week Bill Vaughan of Consumers Union sent members of the Senate a letter about the upcoming floor vote on the bill, which amends the 2002 version of MDUFSA.
"Considering the ongoing public confidence crisis in the safety of our nation's ... medical devices, it is unfortunate that bipartisan legislation ... does not include safety measures to protect American consumers," wrote Vaughan, a senior policy analyst with the organization in New York City.
The new MDUFSA includes provisions to ensure the speedy approval of devices, but it lacks language addressing "failures to protect children and adults in the FDA medical device safety process," Vaughan added. "We hope the Congress will soon address the safety concerns of the nation's 300 million health care consumers for prescription drugs and medical devices."
Although the fee has been reduced, AdvaMed -- the leading trade group representing manufacturers of medical devices -- sees the new cost as providing the FDA, at least in part, with adequate funding for the resources it needs to review and approve product applications, Mark Brager, a spokesperson for AdvaMed, told UPI.
"We support the bill because we believe its strikes a balance between our members and FDA officials," Brager said.
Approximately 80 percent of AdvaMed's members fall under $100 million in domestic annual sales, he added.
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Lydell Bridgeford is an intern for UPI Science News. E-mail: sciencemail@upi.com
Copyright 2005 by United Press International.
