Selling Bad Medicine?

Proventil is one of the most popular asthma treatments available, but its maker, Schering-Plough, is under fire for alleged shoddy manufacturing practices involving it and other drugs used by millions of people, CBS News Correspondent Sharyl Attkisson reports.

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 an FDA inspection of its New Jersey factory and a scathing internal audit never meant for public release uncovered an array of serious violations.

Sent anonymously to Public Citizen, a consumer watchdog group founded by consumer advocate Ralph Nader, the company audit found production emphasized over quality, while sewage and feces "had a pathway" into Proventil.

Also, the audit found that there was no system in place for measuring how much — if any — medicine was going into the inhalers.

If no medicine was actually inside a canister inhaler, it is "potentially life-threatening," said Dr. Henry Fishman, an asthma specialist. "If an asthmatic has an attack and doesn't get the proper medication, they can get seriously ill and occasionally pass away."

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

But even after that, problems at the factory allegedly continued. The federal Food and Drug Administration uncovered many of the same violations — also involving the multi-billion dollar seller 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," said Dr. Sidney Wolfe of Public Citizen.

A spokesman for Schering-Plough, Robert Consalvo, said the company would not comment on Public Citizen's accusations, but confirmed a letter was sent to the company by the FDA regarding non-compliance with so-called Good Manufacturing Practices.

"We are not going to comment about the details of the investigation or the specific observations cited by the FDA," Consalvo said.

Wolfe says it's hard to know how many people may have already been hurt, because 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 spin-off 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 the federal government fr a criminal investigation into whether the company knowingly sold bad medicine.

Public Citizen's report details issues that Wall Street analysts said the drug maker failed to address adequately two weeks ago, when it disclosed the FDA was investigating manufacturing practices at its plants in New Jersey and Puerto Rico.

The withholding of FDA approval for Clarinex and the revelations about the Kenilworth, N.J.-based Schering-Plough, coupled with the company's slashing of its first-quarter earnings outlook, sent its stock plunging Thursday.

Schering-Plough shares closed at $38.78 on the New York Stock Exchange, down $1.47 or 3.65 percent on the day. The stock is well off its 52-week high of $60 reached in December, and has under-performed its peers on the American Stock Exchange Pharmaceutical index by about 21 percent since the start of the year.