FDA Finds Bits Of Steel, Rubber In Genzyme Drugs

BOSTON — Officials with the Food and Drug Administration said bits of steel, rubber and fiber have been found in drugs made by Cambridge-based biotechnology company Genzyme.

Four of the five drugs found to be contaminated are ones used to treat rare enzyme disorders; the other is used for thyroid imaging. All were manufactured or finished at Genzyme’s Allston Landing manufacturing plant.  This contamination is separate from a viral contamination reported over the summer.

Genzyme's Allston manufacturing facility. (AP)

The drugs are not being recalled, because they are complex medications made in such small batches that patients with the disorders would be too compromised, said Jason Woo,  associate director for medical and scientific affairs in the office of compliance at the FDA’s Center for Drug Evaluation and Research.

“These are products that are medically necessary for unique populations,” he said. ” Because of that, we are trying to work with the firm to assure that product remains available within a reasonable risk-benefit profile.”

FDA officials said no patients have been affected by the contamination. However, FDA doctors said among the more serious reactions that could occur are damage to blood vessels, anaphylactic reactions or blood clots.

“These are possible, but none that we’ve directly had reports of occuring,” said Julie Beitz, director of the Office of Drug Evaluation and the Center for Drug Evaluation and Research at the FDA.

The drugs are typically administered by doctors, either by intramuscular injection or intravenously. Doctors are being warned to do a visual inspection of the drug first and if it appears clear to run it through a filter before administering it.

The FDA said Genzyme first alerted regulators about the debris in May, but that the problem has now risen to the level that healthcare providers have to be notified.

“It appears that Genzyme feels that the problem is large enough to warrant that this additional information be provided to healthcare providers,” Woo said.

But Geoffrey McDonough, Genzyme’s senior vice president and general manager, genetic diseases business unit, said particles are a typical byproduct of manufacturing injectible drugs, and that the company has not seen an increase in the number of vials discovered with particles.

Instead, he said the company alerted the FDA and healthcare providers for three reasons.

“The industry at large is working to create a consensus view of what level of these particles is and should be considered acceptable, ” he said.  “Second, the FDA has had several cases in the last few months of manufacturers who have issued recalls for issues in this range… so I think the FDA of course in their own way is bringing this issue to the forefront of their attention.”

He added,  “Finally… we’re in the process of restarting and bringing back online this very large facility in Allston and the FDA is completing about three weeks of inspection in that facility… so I think it’s just a combination of these three things that have brought this issue into focus.”

Part of the company’s Allston plant has been shut down since the summer, when a virus contaminated the facility. That contamination led Genzyme to shut down its plant temporarily. McDonough said  the plant is almost done being brought back online.