Feds Nix Ban on Drug Vials

The Food and Drug Administration (FDA) has rebuffed a proposal by New York state and city health officials to end the manufacture of multi-dose medicine vials. Locally, at least one hepatitis C infection was transmitted several years ago through syringe reuse involving multi-dose vials at the Plainview pain management practice of Dr. Harvey Finkelstein.

On Jan. 18, state Health Commissioner Dr. Richard Daines and New York City Health Commissioner Dr. Thomas Frieden wrote a letter asking the FDA chief to stop the manufacture and distribution of multi-dose vials. Despite "numerous guidelines and recommendations," some individual physicians continue to misuse needles and syringes, leading to the contamination of multi-dose vials, Daines and Frieden wrote.

On Oct. 20, FDA Commissioner Dr. Andrew von Eschenbach replied, saying multi-dose vials "are an important dosage option for hospital pharmacies," are less costly, and require less storage room than single-dose vials. Instead, the agency may include warnings with multi-use vials and post instructions about their proper use on FDA's Web site, von Eschenbach said.

Daines said he was frustrated with the response. "I don't think they understood the problem," which involves individual practices and not hospitals, he said. "I would like safety engineered into the product," said Daines, who said he will raise the issue again with the incoming Obama administration.

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