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Generic Drug Maker Able Had Prior Problems With FDA

May 25, 2005 | AP

Generic drug maker Able Laboratories Inc., which this week recalled all of its drugs and shut down manufacturing over quality questions, has a long history of problems with regulators, government documents show.

U.S. Food and Drug Administration reports and letters to the company detail repeated product recalls dating back to at least the early 1990s, a charge of selling adulterated drugs related to sloppy manufacturing, and failure to report dozens of cases of patients suffering serious side effects after taking Able's medicines.

Since last Thursday, Cranbury, N.J.-based Able first halted all product shipments, recalled every product but the three medicines it had already recalled this year, halted its manufacturing operations, and pulled seven drug applications pending at the FDA _ all because its internal probe turned up problems with testing procedures for some drugs.

The extraordinary week also included CEO Dhananjay G. Wadekar resigning, Able withdrawing its prior financial forecast, and at least two law firms initiating class-action lawsuits on behalf of stockholders after the company's shares lost 85 percent of their value. Shares closed up 49 cents up at $4.24 in trading Wednesday on the Nasdaq stock market.

A company spokeswoman who declined to give her name hung up on an Associated Press reporter on Wednesday after saying, "We're not answering any questions at this time."

The latest questions about the reliability of Able's manufacturing and testing procedures have similarities to a 1991 case in which FDA and the Department of Justice charged Able with adulteration, or not complying with regulations for manufacturing, processing, packaging and storing medicines. Able, then based in South Plainfield, eventually paid the government a $45,611 fine to settle the case.

More than 10 different recalls of Able medicines, including three in 1991 and four in 1993, are listed on the FDA's Web site. Those include two medicines that were not as potent as stated, products that were mislabeled or had the wrong package insert, and medicine that had its expiration date extended by the company without proof it would still be effective. This year, Able's three recalls included a blood pressure drug, atenolol, found not potent enough, and a tranquilizer, promethazine, containing impurities.

Last year, FDA sent Able a warning letter over its failure to pass on to the agency 27 different reports Able received from 2002 to 2004 on patients suffering serious side effects involving at least five different drugs. Those symptoms included chest pains and difficulty breathing, "trouble functioning" and a minor stroke. The warning letter noted that Able had not previously reported any patients' side effects to FDA.

FDA spokeswoman Lara Alvey said Wednesday the company has since made changes to satisfy all the FDA's concerns. Alvey said she could not discuss the current situation.

"All the (recent) actions they've taken have been voluntary," she added.

While Able is relatively small, with $103 million in revenues last year and about 420 employees, it makes generic versions of numerous popular brand-name drugs, including the attention-deficit disorder drug Ritalin and the painkillers Vicodin and Tylenol with codeine. It turned out more than 1.3 billion tablets, capsules and suppositories last year at its South Plainfield manufacturing plant.

Until the recent troubles, Able appeared to be on an upswing, with net income jumping 75 percent to $14.6 million and 16 new generic drugs approved for sale in 2004. Earlier this month, its first-quarter earnings report showed net income had nearly doubled to $4.7 million, despite costs for expanding its senior management team, hiring other additional employees and boosting compensation and benefits to keep key employees.

The company also has moved about half its workforce to a new manufacturing and administrative facility in Cranbury, after investing about $35 million in property and equipment.

Ironically, the recent bad news started three days after Able announced it had appointed its head of regulatory affairs, Iva Klemick, to a new position, vice president for compliance, primarily responsible for making sure the company follows federal, state and local regulations.

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