FDA TO TEAM UP WITH EUROPE ON INSPECTIONS

The FDA and the European MedicinesAgency plan to pilot a joint inspectionsprogram of facilities manufacturing pharmaceuticalsin the United States and theEuropean Union, as well as companiesmanufacturing active pharmaceuticalingredients (API) in third countries. Theplan was announced following a recentmeeting of the Transatlantic EconomicCouncil in Brussels.

The project will include the exchangeof inspection schedules, results, andinformation on inspected manufacturingsites. The FDA expects the collaborationwill yield important benefits for industryand patients and result in more effectiveuse of resources and a higher safetylevel of products from third countries.

Concern over the quality of API manufacturedabroad was heightened afternumerous adverse reactions and deathswere linked to contaminated heparinproduced in China (see www.PharmacyTimes.com/OverseasInspections formore information).

A budget amendment to increase FDAappropriations by an additional $275million in fiscal year (FY) 2009 is movingthrough Congress. The agency plansto use the additional funding, in part,to expand its reach beyond Americanborders by establishing a presence inseveral countries and through othermeasures that will help ensure greaterforeign compliance with FDA standards.The increase would bring the FDA's proposedtotal budget increase to $404.7million, a 17.8% boost in funding fromFY 2008.