June 2008

U.S. Congress pledges, bickers, dithers

U.S. lawmakers agree inspections of foreign drug plants after the deaths of dozens of patients treated with a blood-thinner made with imported ingredients from China must happen.

However, they do not seem to agree on who will pay for it. Republicans want the taxpayers to pay for the inspections. Democrats want the drug companies to pay for them.

Reuters reported one proposal would require drugmakers to pay fees to the U.S. Food and Drug Administration (FDA) to boost capacity to check overseas manufacturing sites in an effort to keep counterfeit or contaminated drugs from reaching the U.S. market.

Batches of Baxter International recalled blood-thinner heparin were found to be tainted with a cheaper, heparin-like chemical that FDA officials said may have killed some patients and caused allergic reactions.

Eighty-one deaths came after treatment with some brand of heparin.

More than 80% of active drug ingredients are from abroad, but the FDA has limited staff and funding to inspect overseas manufacturers.

The Democrat-controlled Congress is searching for ways to strengthen FDA oversight of imported food and drugs following a string of recalls of Chinese-made products in the past year, included tainted toothpaste and pet food.
Chinese officials have said the chemical in heparin, over-sulfated chondroitin sulfate, was not to blame for deadly reactions to the drug.

Republicans at the hearing backed the need for more inspections, but some balked at having companies pay the cost rather than taxpayers.

The measure would require FDA inspections of foreign drug plants every two years. It also would mandate that all foreign and domestic drug producers register annually with the FDA and would provide some added enforcement powers.
The cost for the FDA to inspect all pharmaceutical plants around the world that supply the U.S. market would be about $225 million annually.

The U.S. Government Accountability Office (GAO) kicked off a hearing on Boeing Company's protest of a $35 billion U.S. Air Force refueling aircraft contract won by Northrop Grumman Corp and its European subcontractor the European Aeronautic Defense and Space Company, or EADS.

The congressional agency, which reviews contract disputes, is due to rule on the case by 19 June.