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Amid meningitis outbreak, US Congress urged to expand FDA oversight

Source: Thomson Reuters Foundation - Wed, 10 Oct 2012 19:42 GMT
Author: Reuters
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WASHINGTON, Oct 10 (Reuters) - The Obama administration on Wednesday urged Congress to give the Food and Drug Administration greater authority to regulate compounded drugs of the kind linked to a deadly meningitis outbreak spanning 10 U.S. states.

"This outbreak began at a compounding pharmacy and the FDA has very limited authority over what these facilities produce," said an official from the U.S. Department of Health and Human Services (HHS), who spoke on condition of anonymity because of ongoing public health investigations.

"We urge Congress to give FDA the authority it needs to assure these kinds of outbreaks do not happen again," the official told Reuters.

The administration official's remarks added to pressure for congressional action as the number of fungal meningitis cases linked to contaminated spinal injections rose. Health officials said on Wednesday a total of 12 people have died and 137 people have been stricken with the rare infection.

Staff from two main committees that oversee health issues in the Senate and House of Representatives were expected to receive briefings on Thursday from FDA and Centers for Disease Control and Prevention staff, a prelude to considering legislative action.

HHS oversees the FDA, which is responsible for ensuring the safety and efficacy of drugs produced by pharmaceutical manufacturers. But it is less clear how much authority the agency has over pharmacies that alter or mix drug ingredients to meet the special needs of doctors and their patients through a practice known as compounding.

Two House Democrats have announced plans to introduce new legislation to strengthen FDA oversight and protect consumers. Democrats in the House and Senate have also called for congressional investigations and hearings.

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