FDALegislativeWatch

Pregnancy Registries Should Not Be Mandated In Drug Label, Amgen Tells FDA

Industry is challenging one of the central components of FDA's proposed rule on pregnancy and lactation labeling - that any existing registries for patients should be included in labeling.

From FDA's point of view, including information on pregnancy registries in labeling would enable consumers to enroll in such programs and obtain further data.

In comments on the proposed reg, however, Amgen cautions against potential shortfalls of registry data. The firm notes that though such information is "appropriate in most situations ... it is based on the premise that all pregnancy exposure registries are adequately designed and executed, which is not always true."

Advisory Committee Vacancies Remain High As FDA Revs Up Search Efforts

With its recent hiring push drawing attention, FDA is quietly undertaking another recruitment effort - filling advisory committee roster vacancies.

Even while FDA labors to implement its Safety First initiative and new authorities granted by the FDA Amendments Act, process improvements for the agency's advisory committee system, including the more proactive and systematic approach to recruiting committee participants, have remained a focus at the highest levels.

In a recent blog posting, FDA Commissioner Andrew von Eschenbach commented that "our advisory committee function is ... one of my highest priorities in our agency-wide process improvement effort."

Senate Panel Matches Commissioner’s “Professional Judgment” Budget

A supplemental appropriations/war funding measure containing $275 million for FDA cleared the Senate Appropriations Committee May 15.

On the same day, the House passed its FY 2008 supplemental funding package - but without the added money for FDA.

The Senate committee's allotment for FDA matches the amount of additional resources that FDA Commissioner Andrew von Eschenbach says his agency needs immediately in order to enhance its oversight of food and medical products (see chart: "¹FDA's Additional Immediate Resource Needs").

FDA Coffers Fill With Funds, But No Money For Reagan-Udall Or Lab Closures

This article is reprinted from the January 7, 2008 issue of "The Pink Sheet"

FDA enters 2008 with the financial wherewithal to go full speed ahead in hiring and establishing the safety programs authorized by the FDA Amendments Act, following President Bush's signing of an omnibus fiscal 2008 appropriations package on Dec. 26.

House Republicans Seek Top Down Change To FDA's Warning-Letter Appeals

This article is reprinted from "The Tan Sheet" – November 26, 2007

FDA leadership needs to review the agency's enforcement dispute resolution process, according to ranking Republicans on the House Energy and Commerce Committee.