Apotex warned by U.S. to raise quality control standards

Canadian generic drug maker Apotex Inc.'s exports to the United States could be blocked if the company doesn't correct quality control problems, according to a warning letter from a U.S. regulator.

The U.S. Food and Drug Administration's website includes a warning letter sent to Apotexdescribing "repeated deficiencies" in quality control, such as ensuring drug products at one of its Toronto-area plant were free of bacterial or fungal contamination.

The FDA's letter from Feb. 21, 2013raised questionwhether the company sufficiently addresseda "critical defect" witha partial batch of rejected tablets.

In another case, the FDA saidsometablets were internally rejecteddue toblack specks on them, but a definitive root cause was never found and the rest of the lot of tablets was released into the U.S..

Dr. Jeremy Desai, the president and chief operating officer of Apotex, said the company responded to the FDA in March, saying the bacterial contamination has been rectified.

Desai said he wanted to reassure Canadians that the products were never shipped to market.

"Canadians can feel very confident of the Apotex brand as a quality, affordable medication that has helped patients for close to 40 years," he said.

Regulations for quality control continually evolve and the company works to ensure its internal checkskeep up to date, Desai said.

But news of the warning letter comes as the company and Health Canada face criticism over releasing one lot ofbirth control pillsthat may have contained an extra week of placebo pills, that raise the possibility of unplanned pregnancy.

Packages of Alysena-28 should have three rows of active pink pills and one row of white placebo pills but packages contained extra placebo pills, Health Canada said earlier this month. Apotex is the distributor of the pills, but not the manufacturer.

"This was really an unprecedented event to have faulty birth controls reach women," said Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynecologists of Canada in Ottawa.

"We were wondering how on Earth this could this have happened. Well maybe this is why," she said of the problems identified by the FDA. Canadian pharmaceuticals should be held to highest standards in the world, particularly as pills are increasingly manufactured overseas, Blake said.

Prof. Amir Attaran ofthefaculty of medicine at the University of Ottawastudies substandard drugs. All drug companies have periodic quality issues, he said.

Attaran pointed to the deadly fungal infections that were identified in the U.S. in September and linked to a large Massachusetts compounding pharmacy. More than 700 Americans were sickened with meningitis and more than 50 others were killed.

Attaran faults Health Canada for not being more vigilant in its own inspections of Apotex's facilities, regardless of whether the products identified by the FDA made it to market in this country. Hesaid the Canadian agency has one of the poorest records in the developed world when it comes to overseeing drug manufacturing.

"Today, history repeats itself," Attaran said. "The FDA has caught what are apparently very serious problems, potentially life-threatening problems with Apotex and Health Canada appears once again, second."

Jean Saint-Pierre,manager of Health Canada's Health Products and Food Branch Inspectorate in Ottawa, said the department's inspectors were with the FDA during the inspections and there were no issues of concern.

Health Canadacontinues to monitor the effectiveness of the birth control recall to check it was done correctly and thoroughly, Saint-Pierre said, addingthe regulator is getting good co-operation with the company.

The departmentsaid the products identified by the FDA never made it to the market in Canada.