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.
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.
“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.