FDA Report Says Able Laboratories Fudged Drug Tests

Able Laboratories, which recalled all of its prescription drugs in May in one of the USA’s largest drug recalls, failed to tell regulators when drugs failed quality tests and sometimes substituted failing with passing results, the Food and Drug Administration says.

The substitutions involved “cutting and pasting” computer records and were done by supervisors and lab analysts, the report says.

The report, posted on Able’s website Monday, also says “senior management” failed to ensure that Able’s products were as safe and pure as they were represented to be. The FDA’s citations indicate “a widespread lack of quality control,” says Steve Kradjian, regulatory and quality consultant to the drug industry.

Able officials could not be reached for comment late Tuesday afternoon. The company has repeatedly refused comment beyond its public statements.

Able produced about 30 generic drugs, including generic Tylenol with codeine, blood-pressure drug Atenolol and nitroglycerin tablets for chest pain. It recalled all products May23, citing testing deficiencies.

The FDA inspection reviewed records from July 2001 through March. The report says the New Jersey-based company, which produced 1.3 billion tablets, capsules and suppositories last year:

*Routinely retested drug samples that failed quality control checks until they passed.

*Failed to report results when drugs failed potency or other checks, including a tablet’s ability to dissolve, which affects a drug’s release into the body.

*Reported only passing test results and not failures to the FDA when it asked permission to stop doing one quality control test.

The company, in a letter to the FDA Friday, had no response to the FDA’s specific findings. It asked for a consent decree, which would provide a “court-supervised means” for Able to address the FDA’s findings and, subject to FDA approval, reintroduce products to the market, the letter says.

Able operated under a consent decree for 10 years until 2002 and passed 11 FDA inspections in the past three years. FDA spokeswoman Kathy McDermott says Able’s proposal is under review but that the FDA is still investigating.

Since the recall, Able, which had sales of $103 million last year, has halted manufacturing and laid off most of its employees. Its CEO and then its interim CEO resigned. It has said it will evaluate a variety of options, including bankruptcy. Able shares fell 4% Tuesday to $1.42, down from $25 in early May.