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Drug-approval pendulum



Published: Fri, January 21, 2005 @ 12:00 a.m.



Drug-approval pendulum

Los Angeles Times: No drug is completely safe. Scientists may understand the basics of how painkillers, antidepressants and other widely used medications work, but they don't claim to know the entirety of how they alter human physiology. Federal regulators have to constantly tread a thin line between a drug's benefits and its risks in deciding whether to approve its use, either by prescription or over the counter.

Last week, a federal advisory panel turned down a plan by two big drug companies to sell the cholesterol-lowering drug Mevacor without a prescription. The panelists said the proposal by Merck & amp; Co. and Johnson & amp; Johnson didn't do enough to prevent one of its known side effects: birth defects, at least in animal testing. Women might take it without knowing they were pregnant or might ignore or miss a warning label.

Mevacor is not obviously more dangerous than many of the 700-plus over-the-counter products on the market with ingredients that were available only by prescription 25 years ago. It's a pendulum issue, like so much of government regulation. Too much laissez faire lets public danger mount. When harm is proved, the reaction is to clamp down until the storm blows over.

The Vioxx fall-out

Political pressures on the FDA began mounting last September, when Merck voluntarily pulled its over-the-counter anti-arthritis drug Vioxx off the market after studies showed increased risks of heart attack and stroke. Consumer watchdog groups had been urging the FDA to pull Vioxx for years, so the government's previous defense of it looked too much like a buddy relationship with Merck.

In recent weeks, leaders of both parties in Congress have agreed that the agency pays too little attention to drugs after they go on the market. There's also general agreement on a fix: beefing up the FDA's ability to track the safety of prescription drugs after they land on pharmacy shelves, perhaps by analyzing the health records that a huge HMO like Kaiser keeps on its members.

A more contentious issue is whether, in exchange for tighter regulation, drug companies' liability should be more limited.

A recent administration proposal to limit medical malpractice lawsuits would sharply limit lawsuits for any injuries that a drug label warned about. Considering the length and tiny type of some side-effect warnings, that puts too much of the burden on consumers.




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