Editorial: Better drug oversight

Saturday, May 12, 2007 | 7:22 a.m.

The Senate has passed legislation that would give the U.S. Food and Drug Administration the authority to more thoroughly regulate drug safety, including how drugs are labeled, advertised, used and distributed.

Currently the FDA's involvement is predominantly one of overseeing the testing of drugs during the years of research preceding approval. But the legislation passed Wednesday would add the FDA's scrutiny to what The New York Times described as "the entire life cycle of the drug" by requiring the agency to track a drug's marketing and use, and monitoring any adverse effects that patients experience.

The bill, which consists mainly of recommendations from the National Academy of Sciences, is likely to be approved by the House in a similar form and become law, the Times reports.

Whether it will pass presidential muster is anyone's guess. Although the Bush administration has not openly opposed the measure, the Times reports, it has said the FDA already possesses all the power it needs to adequately monitor prescription drugs.

But recent problems with three prescription painkillers clearly illustrate that is not the case.

On Thursday three current and former executives of the company that makes the painkiller OxyContin pleaded guilty to criminal charges that they lied to regulators, doctors and patients about the narcotic's potential for addiction and abuse. Purdue Pharma, the company that markets OxyContin, claimed that the painkiller's time-release formula had a lower potential than traditional short-lasting painkillers for abuse and addiction. The opposite turned out to be true.

In unrelated incidents, the painkillers Vioxx and Bextra were removed from the market in the past three years after reports of deaths or serious side effects.

Such incidents show that the FDA's oversight of prescription drugs should not end when a drug's clinical trials are over but should be ongoing, so that continued use of the drugs is based on sound science, rather than having blind faith in pharmaceutical companies' marketing claims.