Drug makers back in FDA hot water

“Manufacturers who choose to wait until FDA investigators find violations rather than policing themselves will find that they have made a poor and costly decision.”
FDA's Lester Crawford

Mark A. DeSorbo

ROCKVILLE, MD-For the second time in the span of just over a year, two drug makers, the Schering-Plough Corp. and Abbott Laboratories, are in trouble with the U.S. Food and Drug Administration (FDA) for numerous and repeated instances of substandard manufacturing.

In mid-May, Schering-Plough (Kenilworth, NJ) agreed to pay a record $500 million to the federal government because of continued failure to fix problems in manufacturing hundreds of drugs at four of its factories-two in Puerto Rico that are now the focus of a criminal investigation because of willful noncompliance.

“This action is another clear sign that the FDA will continue to enforce the rules and regulations requiring companies to carefully control and monitor their processes used to make pharmaceuticals and other products, so that those products will be safe and effective,” says Lester M. Crawford, FDA's deputy commissioner. “Manufacturers who choose to wait until FDA investigators find violations rather than policing themselves will find that they have made a poor and costly decision.”

Meanwhile, Abbott Labs (Abbott Park, IL) is now locked into a consent decree with the FDA after it was informed by the FDA that its Lake County diagnostic manufacturing operations does not conform with “Quality System Regulation (QSR),” following an inspection of the plant that was concluded in January.

Defining the decree
Schering-Plough's agreement to pay $500 million, if approved by the U.S. District Court in Newark, NJ, will be the highest penalty imposed on a drug maker for failing to comply with current good manufacturing practices (cGMPs). The fine also smashes the record $100 million Abbott

Labs paid last year to settle shoddy manufacturing claims. [See “Drug makers beware, FDA on the prowl,” CleanRooms May 2001, p. 1].

Along with the fine, Schering-Plough, the maker of blockbuster drugs Claritin and now Clarinex, has also signed a consent decree that will ensure its compliance with cGMPs at its New Jersey and Puerto Rico.

According to consent decree, the company will retain outside experts in determining that manufacturing methods, procedures and controls at these production facilities comply with current cGMPs. Schering-Plough also says that while these efforts are ongoing, its production facilities will remain open and it will continue to manufacture its human pharmaceutical products. As specified in the consent decree, the New Jersey and Puerto Rico facilities will operate under tightly controlled conditions requiring additional levels of review and reporting.

“This agreement builds upon the efforts we have undertaken to date to resolve these manufacturing issues,” says Richard Jay Kogan, Schering-Plough's chairman and chief executive officer. “The company has worked closely and cooperatively with the FDA throughout this process and achieved two key objectives: keeping our plants open and operating, and continuing to make available our major pharmaceutical products to meet the needs of patients.”

The company, he adds, is confident of its ability to move forward under the agreement and complete improvement programs successfully, emphasizing that the company is confident that all of its pharmaceutical products currently in the marketplace are safe and effective.

Like Schering-Plough, Abbott Labs spent millions trying to appease regulators, but still came up short.

In mid-May, during the same week Schering-Plough was slapped with its fine and consent decree, Abbott Labs was informed that its Lake County manufacturing facility did not comply the federal quality system regulation. The facility's failure comes one year after Abbott Labs was fined $100 million for serious deficiencies in the production of medical diagnostics and screening devices and for ignoring FDA warning letters for six years.

“We are obviously deeply disappointed with the decision,” says Richard A. Gonzales, president and chief operating officer of the Abbott Medical Products Group. “We remain committed to ensuring that the quality system meets the agency's expectation, and that the diagnostic products impacted by the consent decree are made available to patients, laboratories and hospitals as soon as possible.”

The manufacturing malady
Along with cracking down on substandard drug making, the FDA is also trying to encourage as well as provide incentives to drug makers to employ “state of the art manufacturing and quality control techniques,” Paul Heldman, a health care analyst for the Schwab Washington Research Group (Wash ington, DC), told CleanRooms.

“The industry has said, and I don't think the FDA disagrees with this, but by modernizing their plants that would lengthen the process for gaining approval for new products,” Heldman adds, referring to the overall cost of the physical upgrade, the implementation of that upgrade and the eventual re-validation of the procedures. “If you adopt better quality control techniques, it's going to save you money over the long run, but over the short term, it could wreak a lot of havoc because it could make it harder to get products through the approval process.”

In addition, Heldman says the FDA, which has also criticized the manufacturing practices of other drug makers like Eli Lilly and Wyeth, feels the industry does not focus enough attention on the process.

“I think there is a sense among the regulators that the heads of [drug] companies have not focused on manufacturing,” he adds. “They have focused too much on research and development, so I don't think it's a matter of indifference on the part of the manufacturer. It's a matter of where they focus their time, and the FDA is saying 'you have to pay attention to the end product.'”


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