Drug Manufacturing Safety Concerns

There are new questions about the safety of some of the nation's best-known and most widely used prescription drugs.

The problem appears to center on what is and is not in the drugs that come out of a factory, and what the government is and is not doing about it. CBS News correspondent Sharyl Attkisson has been investigating the issue.

Proventil is one of the most popular asthma treatments. But now its maker, Schering Plough, is under fire for alleged shoddy manufacturing practices involving Proventil and other drugs used by millions.

A US Food and Drug Administration (FDA) inspection of Schering Plough's New Jersey factory and a scathing internal audit never meant for public release uncovered an array of serious violations.

Sent anonymously to the consumer watchdog group Public Citizen, the company audit found production emphasized over quality. Sewage and feces "had a pathway" into Proventil, and there was no system for measuring how much--if any--medicine was going into the inhalers.

"It's potentially life-threatening. If an asthmatic has an attack and doesn't get the proper medication, they can get seriously ill and occasionally pass away," says Dr. Henry Fishman, asthma specialist.

The internal audit may have been why the company recalled 60 million Proventil inhalers last year, warning they "may not contain active drug."

But even after that, problems at the factory continued. The FDA uncovered many of the same violations--also involving the multi-billion-dollar seller allergy drug Claritin and a dozen other drugs--when it inspected the plant just last month.

"The FDA comes in 10 months later and finds a lot of the same kinds of problems, and if history is any lesson, we may well wind up having more recalls of Schering Plough products," says Dr. Sidney Wolfe of the consumer advocate group Public Citizen.

Wolfe says it's hard to know how many people may have already been hurt, since the ingredients in medicine are rarely examined after injuries or deaths. The FDA has ordered some production lines halted, and won't allow Schering Plough to ship its new spinoff of Claritin--Clarinex--until the problems are solved.

Schering Plough says its products now on the market are safe and effective, and it will continue to act in the public's best interest. But Public Citizen is asking for a criminal investigation into whether the company knowingly sold bad medicine.

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