U.S. Lawmakers Push FDA to Inspect More Foreign Drug Manufacturing Factories

Saturday, September 20, 2008 by: David Gutierrez, staff writer
Tags: the FDA, health news, Natural News

(NaturalNews) Congress has promised to raise more money to enable the FDA to inspect foreign drug-making plants more frequently, but has yet to decide upon a method for that fundraising.

A series of recent recalls of products made in China, including pet food and toothpaste, has drawn attention to the risks posed by an increasingly globalized world market. This was highlighted when 81 people died after taking Baxter International Inc.'s blood thinner heparin and the FDA said the cause might have been contamination that occurred in the Chinese factory where the drugs had been made.

"What worries me is that without congressional intervention, this could happen again," said U.S. Representative Frank Pallone of New Jersey.

More than 80 percent of the active ingredients in the U.S. drug supply are manufactured in other countries, but the FDA is not required by law to ever inspect drug plants operating outside of the United States. While the agency does make an effort to do so, lack of funding has hampered these efforts.

Democrats have proposed a law that would require the FDA to inspect foreign drug plants once every two years. According to Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, it would cost $225 million each year to pay for this rate of inspections.

Under the proposed law, this money would be raised by fees leveled on all drug companies producing drugs for sale in the United States that are not manufactured in that country.

Republicans have opposed this funding model, saying that inspections should be paid for with taxes paid by the public rather than fees imposed on corporations.

Woodcock agreed that the FDA needs congressional measures to ensure the safety of the foreign drug supply, but said that focusing on inspection is the wrong approach. Instead, she said, the law "should be more closely targeted and prioritized according to risk" to avoid wasting resources on unnecessary inspections.

Sources for this story include: www.reuters.com.