Claritin Maker to Pay FDA Half a Billion Dollar Fine
By Marc Kaufman
Drugmaker Schering-Plough Corp. will pay the Food and Drug Administration a record $500 million as part of a broad settlement aimed at resolving quality-control problems at four of its factories.
The FDA said that the consent decree covers problems found in the manufacturing of 90 percent of the company's drug products since 1998, and involves 125 prescription and nonprescription drugs.
As part of the decree, the company agreed to suspend manufacturing of 73 products and to pay an additional $175 million if it falls behind in its efforts to improve manufacturing practices. The company said consumers should remain confident of its products, which are now under increased FDA oversight.
The action against Schering-Plough, maker of Claritin and one of the nation's top 10 pharmaceutical companies, is unusual in its size but consistent with the FDA's growing concerns over questionable manufacturing practices. Since the FDA won the authority in 1999 to go after the profits of companies that do not comply with federal good-manufacturing rules, the agency has reached similar though smaller settlements with several other companies.
Agency officials said there are alternatives to all the Schering-Plough drugs on which production will be suspended. These include some formulations of brand-name drugs such as the asthma medication Proventil and the decongestants Chlor-Trimeton and Afrin, as well as generic medications such as theophylline, an asthma drug.
Recalls were initiated early this month of the affected Proventil and theophylline, and several other drugs were recalled over the last few years. While some consumer groups have charged that patients were harmed by problems with Schering-Plough's asthma drug albuterol, the company denies that. FDA officials said consumers can safely use any Schering-Plough products they might have in their homes or any still on store and pharmacy shelves.
The problems detected at the four Schering-Plough plants, in New Jersey and Puerto Rico, involved "manufacturing, quality assurance, equipment, laboratories, and packaging and labeling," according to an FDA statement. An FDA official said the problems had to do with the overall manufacturing practices and quality control, and that the safety and effectiveness of individual drugs were not necessarily compromised.
Company officials said some of the suspended drugs will be discontinued while others will return after the FDA approves changes in the firm's manufacturing practices.
The large settlement comes as the FDA has grown increasingly concerned about manufacturing practices in the pharmaceutical industry and has been pressing reluctant companies to make improvements that agency officials believe are necessary.
Before 1999, the FDA had little power to seek penalties against companies found to be in violation of agency "good manufacturing practices." But a federal appeals court ruled then that the FDA could go after the profits of companies that act improperly, and the agency has won several large agreements since. Abbott Laboratories Inc. agreed to pay $100 million in 1999 to settle accusations that it failed to meet quality standards in the production of medical test kits, and Wyeth Laboratories Inc. agreed to pay $30 million in 2000 to settle accusations of poor manufacturing practices.
The FDA said the Schering-Plough settlement was large because the company was out of compliance for three years, and was highly profitable during that time.
Last year, the consumer group Public Citizen Health Research Group called for a criminal investigation of Schering-Plough, saying that the company distributed albuterol asthma inhalers even though it knew the units were missing the active ingredient. Public Citizen based its claims on a confidential audit it says it obtained.
The company recalled inhalers in 1999 and 2000, and Sidney Wolfe of Public Citizen said that Justice Department officials questioned him about the contents of the audit and the albuterol problems.
"This company for years has grossly neglected the manufacturing of many of its products," Wolfe said. "They were told to clean up their act years ago, but they didn't do it."
Washington Post May 18, 2002; Page A01
| DR. MERCOLA'S COMMENT: |
Another great example of how the drug companies can’t be trusted. Even the FDA, which normally is in collusion with the drug companies had to fine Schering half a billion dollars.
Even that doesn’t seem fair for the despicable action of putting money ahead of lives. How could any company sell life saving medication, like an asthma inhaler without the active ingredient?
Folks this was not a fly by night firm. This is a US top ten drug company and 90% of their products had quality assurance problems.
Really makes you wonder about the others.
Do you really want to place your life in the hands of people who would do this?
Take up the crusade. Start eating better so you don’t get sick and have to take drugs. Start the eating plan today and encourage your friends and relatives to do likewise.
Folks we can change the system.
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