Drugmakers would have to pay 45 percent more to U.S. regulators to speed reviews of new medicines and improve safety monitoring under a measure approved by a Senate panel.
The Senate health committee voted, 15-5, today for legislation that would also give the Food and Drug Administration power to ban consumer advertising of medicines with dangerous side effects for as long as two years and force drugmakers to complete studies after their products are on the market.
The measure would renew and increase fees, paid by drug companies, that otherwise would expire on Sept. 30. The FDA said the legislation is needed to avoid staff layoffs and a slowdown in drug reviews. Lawmakers said the user fee legislation gave them an opportunity to advance their initiatives on drug safety.
``We want the drugs to be as safe as possible,'' said Senator Michael Enzi of Wyoming, the health committee's top Republican, during the meeting. ``We also want to be able to get new drugs to market as fast as possible -- with the assurance that they will be safe.''
Members of Congress have criticized the FDA for failing to protect the public from deadly drugs, including Merck & Co.'s Vioxx painkiller. It was withdrawn in 2004 after being linked to heart attacks.
The legislation, which also includes new fees for medical device makers, will be forwarded to the full Senate. The House plans to take up similar measures.
Estimated fees for drugmakers would total $442.8 million for the fiscal year beginning Oct. 1, up from $305.5 million and $50 million more than a proposal negotiated by companies and the FDA. The actual amounts may be higher depending on the agency's workload.
The added money -- which would be reduced if Congress increases the FDA's budget at a rate higher than inflation -- would be used to improve drug safety.
No disagreement was voiced during the meeting today over the fee amounts in the legislation, which was introduced by Senator Edward M. Kennedy, a Massachusetts Democrat and the committee's chairman.
Democrats turned back an effort by all of the panel's Republicans to strip language allowing the FDA to limit consumer advertising by drugmakers. Lawmakers debated whether the restrictions would violate free speech protections.
``These provisions fly right in the face of the Constitution,'' said Senator Pat Roberts, a Republican from Kansas.
The FDA would restrict advertising only in rare cases when there are safety concerns about a drug, Democrats said.
``This is an extremely important authority for the agency to have to protect the public health,'' Kennedy said.
More from Justin Blum at Bloomberg
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