Analysis: Senate backs FDA reform bill

WASHINGTON, May 9 (UPI) -- The Senate backed a bill reforming the Food and Drug Administration Wednesday, increasing fines for industry wrongdoing, but avoiding several efforts to strengthen the agency's authority.

The reforms are part of a larger package reauthorizing a $370 million user fee program. Under the program drug makers pay money directly into FDA coffers in exchange for a guarantee of faster drug approvals.

Lawmakers voted to give the agency new power to compel drug companies to conduct studies of the safety of drugs already on the market. It also gave it new authority to change drug warning labels without first negotiating with firms.

FDA reforms have been on the congressional agenda since 2004, when Merck pulled the pain drug Vioxx from pharmacy shelves after evidence emerged that it raised heart attack and stroke risk when used by patients long term.

"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., the bill's main sponsor.

The bill passed 93-1 after a week of debate on the Senate floor that at times involved intense behind-the-scenes negotiations. Sen. Bernie Sanders, I-Vt., voted against the measure.

"This bill will meet the challenges of protecting American consumers and patients and usher in a new era of drug safety," said Sen. Mike Enzi, R-Wyo., the bill's chief GOP sponsor.

Some lawmakers who supported the bill in the end said it was significantly weaker than they had wanted.

"It was alright," Sen. Byron Dorgan, D-N.D., said of the bill. He got broad support for a measure allowing U.S. consumers to import lower-cost drugs from Canada and other industrialized countries. The Senate then blocked the program because of a threatened White House veto.

Lawmakers also narrowly rejected an attempt to crack down on the conflicts of interest on FDA expert advisory panels. One amendment would have restricted panels to just one member with financial ties to industry, but that was rejected after a tied 47-47 vote.

Watchdogs have criticized the panels, and the FDA recently adopted stricter conflict-of-interest standards.

Kennedy's original bill gave the FDA the power to block direct-to-consumer drug advertisements for the first two years of a medication's marketing life. But the provision was removed before a final vote.

The Senate also rejected an amendment creating an independent FDA office to monitor the safety of the U.S. drug supply. Such monitoring is now under the authority of the division that approves new drugs, an arrangement some lawmakers called a conflict of interest.

Pharmaceutical companies lobbied Congress heavily on the bill. The industry opposed drug importation and broad new regulatory authority for the FDA.

"Patients will continue to have timely access to innovative therapies, and they can be assured that the medicines they receive are reviewed under the most rigorous safety and efficacy standards in the world today, said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America.

Tauzin, a former Republican congressman from Louisiana, chaired the House committee that oversees the FDA.

Consumer groups gave the bill a mixed reaction. David Sloane, chief lobbyist for AARP, called the bill "a good start" to lowering drug prices for seniors but said "much remains to be done."

But Sidney Wolfe, director of Public Citizen's Health Research Group, said the bill would do little to improve patient safety.

Wolfe said the bill did not address concerns that the FDA routinely ignored the advice of some of its scientists over drug-safety issues. He also criticized the approval of the 15-year-old user fee program.

"If anyone thinks (user fees) do not alter FDA's vigilance over the industry, they're just delusional," Wolfe said in an interview. "Anyone who thinks this is going to slow or halt the seemingly endless series of drug disasters is really wrong."

Lawmakers approved one amendment boosting fines the FDA can impose on drug makers from $10,000 to $250,000.

"These penalties need to be more than just an insignificant cost of doing business in order to affect behavior," said Sen. Charles Grassley, R-Iowa, who sponsored the measure.

The bill must now go to the House of Representatives, which is considering a slightly different set of reforms.