Bill seeks new drug safety powers

Senate measure would beef up cautions on label

April 28, 2005|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,LOS ANGELES TIMES

WASHINGTON - Leading lawmakers unveiled legislation yesterday that would give the government broad new powers to ensure drug safety and regulate ubiquitous pharmaceutical advertising.

The bill by Sens. Charles E. Grassley, an Iowa Republican, and Christopher J. Dodd, a Connecticut Democrat, would widen the power of the Food and Drug Administration's safety office by making it independent of the division that approves drugs.

The new drug safety center would have an annual budget of $150 million by 2010, about five times greater than that of the current safety office.

The proposal has the backing of major consumer groups, but it goes well beyond limited reforms announced by the Bush administration and is certain to draw industry opposition. An industry lobby group said it needed more time to review the legislation.

The bill faces hurdles within Congress.

Sen. Michael B. Enzi, a Wyoming Republican who is chairman of the Senate committee that oversees the FDA, supports some new enforcement powers for the agency, but he opposes a separate safety center. In the House, there seems to be little interest in any major changes at the FDA.

However, Grassley and Dodd said they were confident that public support would propel their legislation forward.

The bill follows highly publicized cases in which the FDA was slow to respond to evidence indicating serious emerging risks with painkillers and anti-depressants. Grassley and Dodd embraced many reforms already suggested by academics and other experts who follow the agency. Perhaps none is likely to be more controversial than the proposed advertising rules.

Under the bill, advertising for any new drug would have to incorporate a disclaimer that its risks are not fully known, as well as other cautionary language. The precautions would remain in force for two years after a drug's approval.

The director of the safety center could also impose warnings on ads for any drug that develops safety problems.

The Los Angeles Times is a Tribune Publishing newspaper.

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