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Lawmakers Say Oversight Falls Behind Drug Imports

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By MARC KAUFMAN, The Washington Post

Published: November 1, 2007

WASHINGTON - Although the volume of prescription drugs and drug ingredients coming into the country from foreign manufacturers in developing nations such as India and China has exploded in recent years, the Food and Drug Administration's budget for foreign inspections has not kept pace. And it will be lower in 2008 than it was in 2002, congressional investigators said.

As a result, foreign drug and drug ingredient makers are inspected on average once every eight to 12 years, while American-based manufacturers must be inspected at least once every two years.

Investigators also reported that FDA officials generally do not bring their own translators, and in countries such as China they rely on company-supplied translators to conduct inspections. And they must tell foreign manufacturers in advance that they are coming, while FDA inspectors can go into U.S. plants at any time unannounced.

'Given the high level of foreign imports, this lack of oversight puts American consumers at considerable risk,' said Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee, which has scheduled a hearing today on the subject.

'China alone has more than 700 firms making drug products for the U.S., yet the FDA has resources to conduct only about 20 inspections a year in China,' he said.

A bipartisan group of inspectors from the committee's oversight and investigations subcommittee accompanied FDA inspectors on an August trip to India and China - two nations that have become major players in supplying the U.S. pharmaceutical market.

Neither country has a strong drug regulatory agency.

According to the committee report, the FDA database of foreign companies that supply U.S. markets is limited.

Some senior FDA officials report numbers as low as 2,100 while others said there were 4,400 companies.

The Government Accountability Office reports that while 3,000 companies are registered to import drugs into the United States, nearly 7,000 foreign companies supplied the U.S. market in 2007.

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