Senate OKs Increase of FDA Drug Regulatory Prowess

WENDY TOTH

WASHINGTON — In a move meant to increase consumer safety and confidence in prescription drugs, the Senate passed a bill this week that would give the U.S. Food and Drug Administration the ability to mandate prescription label changes, pull drugs that are considered dangerous from the market, regulate advertising and order new studies for drugs already on the market. FDA would also maintain a database of drug trials to survey adverse effects. In the past, the agency had to negotiate with pharmaceutical companies before making labeling changes and only had the authority to remove a drug from market before the drug was approved. Senators said the bill was in response to incidents like the removal of arthritis drug Vioxx in 2004, after it was found to increase the likelihood of heart attack and stroke. A House hearing on the bill is due in July.

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