New Law A Step Toward Safer Drugs

	NEW RX DRUG LAW OF THE LAND—Paul Brown (left), our chief advocate on the FDA reform bill that became law in September meets with Rep. Frank Pallone (N.J.) a supporter of the bill.

New U.S. PIRG-backed legislation signed by the president in September should make the drugs we put in our medicine cabinets a little safer.

U.S. PIRG urged Congress to stand behind provisions that would require greater transparency in clinical trials of new drugs, greater independence on FDA drug safety panels, and greater accountability for drug companies that fail to perform required safety studies—including fines of up to $10 million.

According to Paul Brown, our lead advocate on the issue, controversies surrounding the harmful side effects of such drugs as Vioxx, Paxil and Avandia left members of Congress more open to our push for reform.

“In the end,” he said, “there were too many headlines about dangerous drugs. Congress had to act and we’re pleased they did.”

The Fight For Strong Rules
The bill’s near-unanimous final approval belied the intense debate that surrounded its key provisions. We made it a priority to require drug companies to disclose clinical trial results—a step vehemently opposed by drug industry lobbyists.

U.S. PIRG spearheaded the Patients and Consumers Coalition, which included groups ranging from the Union of Concerned Scientists to the Breast Cancer Fund. We made the case for mandatory posting of clinical trials in our meetings with key congressional leaders, including Rep. John Dingell (Mich.), Rep. Frank Pallone (N.J.), Rep. Henry Waxman (Calif.), Rep. Ed Markey (Mass.), Sen. Ted Kennedy (Mass.), Sen. Jack Reed (R.I.), Sen. Dick Durbin (Ill.) and Sen. Barbara Mikulski (Md.), who ultimately championed the provision.