FDA needs poison pill

THANKS TO A landmark decision by the U.S. Supreme Court last week, Diane Levine will get to keep $6.7 million that a Vermont jury awarded her in a suit against the pharmaceutical giant Wyeth.

She would rather have her hand back.

A professional musician, Levine's lower arm was amputated after an intravenous push of Phenergan, an anti-nausea drug manufactured by Wyeth, caused near-immediate gangrene. The drug company knew about the risk from faulty IV administration of the drug. But Wyeth claimed that it couldn't be sued in state court because Phenergan had been approved by U.S. Food and Drug Administration.

For most of its history, the FDA considered private lawsuits another layer of protection for patients, identifying negative side effects of the now 11,000 drugs on the market that it may not have caught in clinical trials. Over the past few years, though, the Bush administration turned the FDA into a vehicle, not for protecting Americans from bad drugs, but for protecting drug companies from Americans trying to hold them accountable.

The court's decision affirming consumer rights to bring lawsuits was a direct slap at the FDA policy of "pre-emption" adopted in 2006. The FDA - with input from the White House - had claimed that drug companies afraid of lawsuits would put "unnecessary" warnings on their drugs, resulting in "underutilization" of treatments. (Translation: lower profits.) Besides, FDA claimed, its labeling of drugs and medical devices was "fully accurate" and "up to date" - a claim key career officials in the agency said was a "gross overstatement."

The era of wholesale government deregulation that began with Ronald Reagan hit FDA very hard, and with it our confidence in the safety of the items we put in our bodies. The agency's funding and staff have been reduced so much that it routinely fails at its basic oversight responsibilities. Drug companies have exercised undue influence, with scientists taking a back seat to political appointees pursuing policies that favored the pharmaceutical industry. The result: calamitous side effects from drugs like Vioxx, Avandia and Heparin, among others.

Last week's Supreme Court decision reinstates basic legal rights for consumers, but lawsuits are filed only once something terrible has happened. How much better - and cheaper - to prevent catastrophes.

What seems like a crisis a month in food and drug safety - from e.coli in meat, salmonella in peanut butter or deadly side effects in medications -– demands a complete revamping of the way the nation regulates food and drugs.

Two important steps: Congress must undo legislation that led to a Supreme Court decision in February, which blocked state lawsuits for faulty medical devices. And FDA should be broken into two agencies, one for food and the other for drugs, to allow better focus on each area.

Since the Democrats took over in 2007, Congress has increased FDA funding by 40 percent, but its challenges go way beyond money. The FDA was created in 1938, long before antibiotics or chemotherapy were available, and when most or all of our drugs were manufactured in this country. Today's pharmaceutical industry is global, and infinitely more complicated, requiring a more scientifically-sophisticated approach to oversight. Science has produced medical advances undreamed of in the early days of the FDA. Now science - supported by government action and funding - must develop new ways to make sure those drugs and devices are as safe as they can be. *