U.S. Drugmakers would have to pay 29 percent more, to the government to review their products, under a proposal Thursday by the Food and Drug Administration(FDA).
The annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line. The fees are designed to increase the number of agency employees assigns to review commercials.
Drugmakers are not required to have FDA approval before running commercials, but many companies submit them ahead of time to avoid possible penalties for content. Companies have been warned in the past about misleading claims.
"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process," said HHS Secretary Mike Leavitt. "I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals."
The FDA is seeking public comment before forwarding the accord to Congress, which may alter the terms.
Source : FDA
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