New FDA rule

It's an FDA safety rule, but it seems like drug companies got a lot of what they wanted... They want to make sure the agency is funded so they can get swift approval of drugs...

http://www.bloomberg.com/apps/news?pid=20601202&sid=aFtqgW8Pm8QM&refer=healthcare

President George W. Bush signed legislation today giving the U.S. more power to police the safety of prescription drugs, a response by Congress to concern that regulators haven't acted against harmful medications.

The new law grants the Food and Drug Administration authority to make pharmaceutical companies study the safety of their products after they go on the market. Regulators also could order that warnings be added to prescribing information.

The safety changes are needed because of the FDA's failure to crack down when harmful side effects have been identified in medications, said lawmakers who supported the measure. The agency's performance has been questioned in handling Vioxx, the Merck & Co. drug withdrawn in 2004 after being linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.

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The measure renews and increases fees paid to the FDA by makers of drugs and medical devices, such as pacemakers for the heart, to speed regulatory review. Without new legislation, the fees would have expired at the end of this month.

The legislation had the support of drugmakers and some consumer groups. Others, including Washington-based Public Citizen, said the measure didn't do enough to improve drug safety.

`Lost Opportunity'

``The essential problems in drug safety remain unaddressed,'' said Peter Lurie, deputy director of the Health Research Group at Public Citizen, an advocacy organization, in an interview. ``It's an enormous lost opportunity.''

The legislation will encourage the agency to pay more attention to dangers discovered after approval of a drug, lawmakers said. While drugmakers must complete clinical trials before regulators approve their products, harmful side effects often aren't detected until products are more widely used.