House Energy and Commerce Committee To Consider Medical Device User Fee, Medical Error Legislation Today
The House Energy and Commerce Committee is scheduled on Sept. 25 to mark up a bill that would speed up FDA reviews of medical devices by privatizing the system, CongressDaily/AM reports (CongressDaily/AM, 9/25). The bill would allow medical device manufacturers to hire private companies to inspect their plants and review complicated applications, jobs now performed by the FDA. In return, medical device manufacturers would pay "millions" of dollars in user fees to cover salary and operational costs for the FDA division that regulates the equipment (Kaufman, Washington Post, 7/16). The bill would also allow creation of an FDA office of combination products, permit "labeling proposals" to be submitted electronically and call for the FDA to establish rules for labeling medical devices that "are designed for a single use but can be proven safe for reuse when cleaned" (CongresDaily/AM, 9/25). Diana Zuckerman of the National Center for Policy Research for Women & Families said, "The legislation will make it faster and easier for manufacturers to get medical devices on the market, potentially at the cost of patient safety." But Steve Ubl, executive vice president for government relations at the Advanced Medical Technology Association trade group, said, "The medical technology user fee agreement will increase FDA resources and strengthen its review tools," adding, "The changes will prepare the agency for rapid advances in medical technology and ensure patients access to the latest medical tests and treatments" (Orr/Cohen, Newark Star-Ledger, 9/25).
Medical Error Bill
The committee on Sept. 25 also is expected to discuss a bill aimed at decreasing medical errors. CongressDaily/AM reports that the panel might add to the bill two grant programs that would "encourage" use of electronic prescriptions and urge hospitals to "integrate information technology" to prevent errors (CongressDaily/AM, 9/25).
