Vioxx Settlement Reveals Need for Drug Industry Reform

Seth Miles

Contributor

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This morning I ran across an editorial about the recent Vioxx settlement that did a great job pointing out the need for reform in the pharmaceutical industry as well as specific areas where reform is needed. Merck announced a few weeks ago that it would settle Vioxx lawsuits for $4.8 billion.

The list of necessary reforms is long.

The Prescription Drug User Fee Act passed by Congress in 1992 needs to be revisited. The act charged drug companies a "user fee" for every drug approved. That money goes to the U.S. Food and Drug Administration to be used to speed up the approval process.

In other words, drug companies now pay the FDA to approve drugs more quickly. The proportion of FDA's budget provided by such fees has increased dramatically since the act passed, and there's been a corresponding decrease in resources devoted to tracking the safety record of drugs that have already won approval.

More must be done to guard against conflicts of interest. Earlier this year, the FDA approved new rules restricting the participation on safety panels of expert advisers with financial ties to drug makers. While the rules are an improvement over the current system, they need further tightening.

Vioxx was rushed through the approval process, marketed heavily and prescribed to people who did not need it - meaning they had no stomach issues with other pain relievers. And some reports estimate as many as 50,000 people died.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.