Media coverage on a visit to New England Compounding Center by agents from the FDA’s Office of Criminal Investigations on Tuesday was speculative, suggesting the move was related either to unapproved drugs or to controlled substances at the facility in Framingham, Massachusetts.
The CBS Evening News (10/16, story 11, 0:30, Pelley) reported, “In Massachusetts today, agents with the Food and Drug Administration raided the pharmacy linked to a deadly outbreak of meningitis.”
The New York Times (10/17, A23, Tavernise, Grady, Subscription Publication, 1.23M) reports that the FDA’s Assistant Commissioner for Public Affairs, Steven Immergut, “confirmed” that investigators from the agency’s Office of Criminal Investigations were at the New England Compounding Center in Framingham, Massachusetts, yesterday, “but gave no further details. The office looks into suspected violations of federal laws meant to protect public health,” such as manufacturing or selling “unapproved drugs” and importing products regulated by the FDA, illegally. NECC spokesperson Andrew Paven said the Federal agents entered the facility on Tuesday with a warrant. Christina Sterling, a spokesperson for the US Attorney’s office in Boston, said the warrant “was sealed, and its details were not publicly available.”
The Wall Street Journal (10/17, A6, Dooren, Burton, Subscription Publication, 2.08M) adds that US Attorney Carmen M. Ortiz of Massachusetts issued a statement, saying her office is also conducting a probe at the NECC facility, but disclosed no additional details.
Meningitis outbreak reaches 233 cases. The CBS Evening News (10/16, story 11, 0:30, Pelley) reported that the meningitis outbreak “has spread across 15 states. Two hundred and thirty-three people have been sickened, 15 have died.”
USA Today (10/17, Weise, 1.78M) reports that the Centers for Disease Control and Prevention posted an online update Tuesday, indicating 19 “more cases of fungal meningitis infections related to contaminated steroid injections were reported,” whereas the death toll remains unchanged at 15.
Bloomberg News (10/17, Bostick, 1M) adds that after the CDC posted its update, Virginia’s Department of Health issued a statement, confirming that a second meningitis-related death occurred in the state.
Reuters (10/17, McCune) says the newly reported meningitis cases occurred in nine states: Florida (2), Indiana (2), Maryland (1), Michigan (1), New Hampshire (2), New Jersey (2), Ohio (2) Tennessee (6) and Virginia (1), according to the CDC.
FDA issues expanded call for patient notification. The Orlando (FL) Sentinel (10/17, Santich, 189K) reports FDA “officials announced they are expanding warnings to include patients who received any type of injectable drug” from the NECC.
NBC News (10/17, Fox) in its “Vitals” blog adds that the FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, MD, said, “We have looked at practices of the firm and we are concerned that we cannot provide assurances of sterility.” For confidentiality reasons, she could not provide details, but Dr. Woodcock said the agency is urging all “clinicians who administered these products since the end of May” to make contact with all of their patients and “ask about any symptoms they may have.” In addition to the steroid, methylprednisolone acetate, the FDA on Monday raised concerns a second steroid, “triamcinolone acetonide,” and a heart surgery drug, cardioplegia. Meanwhile, Dr. Tom Chiller, a CDC Medical Officer, said a “third mold called Cladosporium has now been found in a patient.” The other two were Exserohilum and Aspergillus.
The AP (10/17, Stobbe) notes that the NECC has declined to comment on “its production process or what might have gone wrong,” but outside experts speculate “dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees” prompted the FDA’s announcement.