Senate bill tackles drug safety, reauthorizes user fee act

Measure also provides the Food and Drug Administration with the clout to require postmarketing studies and label changes.

By Susan J. Landers, AMNews staff. June 4, 2007.

Washington -- With an eye toward avoiding future drug safety flaps, the Senate May 9 passed a bill that, among other things, would require the Food and Drug Administration to monitor drugs more closely after they reach the market.

The provision is intended to hasten the detection of adverse events among newly approved medications. It is one of several drug safety measures included in legislation reauthorizing a program under which drug firms pay the FDA millions of dollars each year for faster review of their products.

When Vioxx (rofecoxib) was withdrawn from the market in 2004, it already had been sold for about five years and used by millions of patients for pain relief before its harmful cardiovascular effects surfaced.

The reputation of the FDA as the watchdog over the nation's drugs was damaged by this controversy and other safety concerns such as risks posed by certain antidepressants. Such events resulted in the agency working with manufacturers to place heightened warning labels on several drugs. But this action happened long after the medicines had been approved and were widely available.

An Institute of Medicine report last fall also pointed to the need for ongoing scrutiny of approved drugs.

"The FDA should be the gold standard for safety, but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs," said Sen. Edward Kennedy (D, Mass.), chair of the Senate Health, Education, Labor and Pensions Committee. Kennedy drafted the bill with the committee's ranking member, Sen. Mike Enzi (R, Wyo.). It was passed by a 93-1 vote. Sen. Bernie Sanders (I, Vt.) cast the lone negative vote to protest the addition of an amendment that gutted a provision allowing drugs to be imported from other countries.