Kennedy Proposes Higher User Fees

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Drugmakers would have to pay 51 percent more in user fees to the FDA to speed new drug approvals under legislation introduced today. The total fees for new drug applications would jump $157.3 million, to $462.8 million, in the fiscal year beginning Oct. 1, under the measure introduced today by Teddy Kennedy, a Democrat from Massachusetts.

The proposed fees would be $70 million more than drugmakers agreed to pay as part of an agreement with the FDA that was submitted to Congress. The added money proposed by Kennedy — which would be reduced if Congress increases the FDA’s budget at a rate higher than inflation — would be used to improve drug safety.

“It’s an important step forward because the amount of safety work that needs to be done that makes the FDA the gold standard is going to cost some money,” said William Vaughan, a senior policy analyst with the nonprofit group Consumers Union, in an interview.

Source: Bloomberg News[tags]DTC Advertising, PDUFA, Safety[/tags]

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