FDA: Merck Can't Market Gardasil to Women 27-45

On Wednesday, drug maker Merck & Co. said federal regulators had rejected its request to expand the marketing of the Gardasil human papillomavirus (HPV) vaccine to include women ages 27-45. The Food and Drug Administration cited "issues that preclude approval" within the anticipated review timeframe, Merck said.

In 2006, FDA approved Gardasil for females ages 9-26, a population unaffected by the new decision. Older women are not prevented from obtaining the vaccine from their doctors; however, Merck cannot market the product to them.

Several issues were involved in FDA's rejection, including data that did not support the use of Gardasil for HPV types not targeted by the vaccine, said Merck.

"This is clearly not what Merck wanted. It reflects the painstakingly slow process that the FDA has in approving anything," said WBB Securities analyst Steve Brozak. "I think this is one where they would rather err on the side of getting another 23 pounds of documents." Merck said it is in discussions with FDA and will respond to the decision next month.

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