RECENT FDA DECISIONS DRIVE LATEST REFORM BILL
Legislation is necessary to force the FDA to more carefully assess the impact on women of its drug and device approvals, a House Democrat says.
Rep. Rosa DeLauro (D-Conn.) will introduce her bill, "The FDA Scientific Fairness for Women Act," next week to address what she sees as an erosion of protections for women regarding drugs and devices. DeLauro is concerned with the agency's recent decision against approving Barr's contraceptive Plan B for OTC sale to minors and its tentative approval of silicone breast implants.
These decisions are a sign of an agency that has been corrupted by political and industry influence, she added. The FDA's image as the "gold standard" for protection of human health "has been tarnished in recent years," she said during a Sept. 21 conference call announcing the bill.
The bill would elevate the agency's Office of Women's Health so that it reports directly to the commissioner. The legislation would also require the FDA to convene a workshop to review and evaluate current scientific data on the use of emergency contraceptives, like Barr's Plan B drug, by women under 18 and require manufacturers to demonstrate the safety of breast implants before approving them.
DeLauro is not optimistic that the bill will move before Congress adjourns for the year. But she is already reaching out to lawmakers who have taken an interest in FDA issues in the past with an eye toward next session.
She is also preparing for the possibility that Democrats will take over the House by courting the members who would likely chair various committees, she said. The House Energy and Commerce Committee would have jurisdiction over the bill, making Rep. John Dingell (D-Mich.), the leading Democrat on the panel, a key player in moving the bill. Additionally, DeLauro would probably become the chairwoman of the Agriculture Appropriations subcommittee, giving her control over funding and staff levels for the agency, including the Office of Women's Health, a congressional source said.
"Every American needs the FDA to make its decisions on the basis of science, not politics, when reviewing drug and medical device applications," DeLauro said. "My goal is to let hard-working and diligent scientists already at FDA do their work without any political or corporate interference."