Capitol Hill In Brief
This article was originally published in The Gray Sheet
Import safety bill: A new draft of the drug portion of the proposed FDA Globalization Act crafted by the House Energy and Commerce Committee and posted on the panel's website July 28 indicates that Congress is continuing its work on the measure, but in separate pieces. The only language pertaining to devices in the draft is the requirement that each drug and device establishment have a unique identification number. However, the House panel is still interested in addressing imported medical device safety, and will most likely take up that section of the bill after the congressional recess ends on Sept. 8, a house staffer said. At a hearing on the act in May, Republican members of the committee's Health Subcommittee, including Rep. Joe Barton of Texas, supported an industry position on the bill that the device components of it should be removed and dealt with separately. Barton opposed requirements in the legislation calling for pre-market inspections of all class II 510(k) devices ("1The Gray Sheet" May 19, 2008, p. 4)
You may also be interested in...
Several device industry representatives told lawmakers on Capitol Hill May 14 that additional FDA user fees and expansion of pre-approval inspection authority to include less risky, Class II devices should not be part of a proposed bill making its way through Congress. They got support from the Republican members of the panel
Democratic leaders in Congress are vowing to craft legislation to effectively overturn the Supreme Court's ruling that PMA approval pre-empts a patient's right to sue device companies for personal injury
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.