Health

FDA is understaffed and lacking the technology to ensure American drugs are safe
by Corina Ciubotaru

Recent findings by the Government Accountability Office show the Food and Drug Administration is facing serious problems when it comes to inspecting foreign drug manufacturers. The situation in the U.S. is good, but apparently two-thirds of foreign drug manufacturers may have never been inspected, partly because of the institutions' outdated computers and databases, that provide contradictory information in regard to the location of the companies seeking FDA approval. American companies are inspected at least once every two years but regulations are scarce when it comes to foreign suppliers. Foreign companies produce as much as 80 percent of the drug ingredients and around 40 percent of all drugs imported in America and it would take the FDA 13 years to inspect all the companies it needs to at the current rate. It uses volunteers to conduct inspections abroad and gives companies a warning before they come, as opposed to the surprise inspections in the U.S., and the inspectors have to rely on English-speaking employees in the visited companies as they are not accompanied by a translator. One option for solving the problem would be to send specialists abroad to set up local counterparts that would be able to gather data much quicker. During a testimony in front of the House Energy and Commerce Subcommittee on Oversight and Investigations, Carl Nielsen, former FDA director for import operations said the Congress issued a report ten years ago that showed the same problems, which apparently haven't been solved since. No need to worry though, drugs in America are still considered to be some of the safest in the world.

related story: http://news.yahoo.com/s/ap/20071101/ap_on_he_me/fda_foreign_drugs;_ylt=AqNORcuCjZ79V3rElQ_ZJTas0NUE

by Corina Ciubotaru for PocketNews (http://pocketnews.tv)

PocketNews is a new real-time news broadcaster delivering the latest and hottest news right to your pocket ! With global clients who want to be kept up to date, PocketNews is everyone's way of keeping in touch with the World.

posted by Blog TechSource @ 5:36 PM