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FDA's overseas offices met with caution

The Secretary of the U.S. Department of Health and Human Services Michael O. Leavitt smiles with Costa Rican Health vice-minister Ana Morice during the opening ceremony of the Federal Food and Drug Administration office for Central America, at the U.S. embassy building in San Jose on January 07, 2009.

TEXT OF STORY

Kai Ryssdal: With all the concern about health in the headlines, here is some reassuring news. Lawmakers want to tighten up on drugs coming here from overseas. The Senate is considering a bill to let the Food and Drug Administration keep more drugs out and at the same time step up the inspections it already does in foreign countries. It hasn't really been that long since the FDA first opened field offices in places like China and India, but some there are already complaining of a witch hunt. Raymond Thibodeaux reports now from New Delhi.


RAYMOND THIBODEAUX: The FDA's inspectors have already raised safety concerns and banned at least four big Indian drug companies from exporting some of their products to the U.S, blocking about 30 products from Ranbaxy Pharmaceuticals, India's biggest pharma company. It prevented sales of Ranbaxy's generic versions of the antibiotic Cipro and the cholesterol pill Zocor.

Ranbaxy declined an on-air interview, but in an e-mail response it said the FDA ban resulted from concerns about just two of its five plants in India.

RANBAXY LETTER: The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing. Ranbaxy will continue to co-operate with the FDA.

The company also says it will issue responses to FDA's concerns as appropriate. But some Indian business groups see the FDA's actions as outright "protectionism" brought about by the lobbying of big American drug companies at a time when the U.S. economy is at a downturn.

AJAY SAHAI: Naturally, in that case you will try to find ways to restrict imports.

Ajay Sahai is executive director of the Federation of Indian Export Organizations.

SAHAI: In many of the cases, Indian companies do have a case where they have been stopped by large companies present in the importing countries. They have tried to restrict the imports at whatever cost or citing whatever reason.

At the FDA's headquarters in Maryland, officials deny that accusation. Dr. Murray Lumpkin is the deputy commissioner of the FDA's Office of International Programs.

MURRAY LUMPKIN: We really as a regulatory agency don't care where the products come from. It simply matters that they indeed are able to show us that they meet our standards for safety, quality and efficacy, and those standards are the same whether it's New Jersey or New Delhi.

India's government has vowed to take up the issue of protectionism with the U.S. But American public concern over tainted drug imports remains high and the FDA's overseas expansion will continue. The agency has plans for field offices in Latin America, the Middle East and Africa. It says this should speed up the approval process, get foreign drugs into U.S. stores sooner and bring down prices for American consumers.

In New Delhi, I'm Raymond Thibodeaux for Marketplace.

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