TRENTON, N.J. (AP) — U.S. regulators have told drugmaker Bristol–Myers Squibb Co. they won't approve an important new drug until the company fixes multiple deficiencies at its Puerto Rico manufacturing plant, the company's CEO disclosed Tuesday.
The problems were disclosed in an Aug. 30 warning letter sent to the company by the Food and Drug Administration. Among the issues raised was a complaint that the plant did not set procedures or have workers follow procedures to prevent contamination of drug products that were meant to be sterile.
Bristol–Myers Chief Executive Lamberto Andreotti gave an update on the problems at its Manati factory Tuesday during a conference call with analysts about Bristol's third–quarter results.
He said Bristol–Myers is "taking all the actions that we think we need to take," including hiring a manufacturing consultant to help.
"We expect that the Manati facility will be inspection–ready by the end of the year," Andreotti said. "Manufacturing continues uninterrupted in Manati."
He said the New York–based company must resolve the problems there before the FDA will approve sales of belatacept, a new biologic drug to prevent rejection of transplanted organs.
The FDA's letter states that unless the violations cited are promptly corrected, FDA could take actions including seizing products made there, withholding approval to export products from there and withholding approval of new drugs that would be made at the facility.
Belatacept, an injected drug, is made at a factory in Syracuse, N.Y., but packaged in vials at the Manati factory, Bristol–Myers spokeswoman Jennifer Mauer said.
The factory already makes two other injected drugs, blockbuster schizophrenia treatment Abilify and rheumatoid arthritis treatment Orencia, plus tablets of Coumadin blood thinner.
"There have been no product recalls" involving the factory, Mauer noted.
Andreotti told the analysts that Bristol–Myers is taking the issue very seriously.
"We do not anticipate any impact to any of our (other manufacturing) sites," he added.
The FDA letter said inspections from March 17 through 31 had identified "significant violations" of the agency's regulations for good manufacturing practices, and that there had been repeated citations after prior inspections.
Among the problems cited after the March inspections:
—Not classifying as a critical defect glass particles and cracks in vials that are rejected.
—Not establishing appropriate specifications, sampling plans and test procedures to assure drugs meet standards for strength, quality and purity.
—Not ensuring that problems with defective "clean room" gowns will be prevented in the future and that the gown supplier has adequate inspection procedures to remove damaged gowns from the clean room supply.
—Not thoroughly investigating the failure of a batch of drugs or any of its components to meet specifications whether or not the batch has been distributed.
The letter states in multiple places that corrections or changes Bristol–Myers has already made are inadequate.
"Our review indicates that there are ongoing problems with your personnel failing to comply with procedures," adds the letter, written by Maridalia Torres, district director for the FDA's San Juan district.
In late–afternoon trading, Bristol–Myers shares were down 42 cents, or 1.6 percent, at $26.74, a bigger drop than its fellow U.S. drugmakers saw Tuesday.