FDA: Contamination found at Mass. compounding pharmacy linked to meningitis deaths
SILVER SPRING, Md. — The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.
The FDA released a copy of its inspection report of the New England Compounding Center, saying that during an inspection of the pharmacy at the beginning of this month, investigators found contaminated products and problems with the pharmacy’s ability to maintain its clean room, an enclosed space designed to have a controlled environment to ensure a sterile environment for drug compounding at the NECC’s Framingham, Mass., pharmacy.
The FDA said that the investigators "observed conditions and practices that, in their judgment, may indicate violations of the Federal Food, Drug and Cosmetic Act, or related regulations," but that the report was not a formal determination that the NECC had committed any violations.
These included contamination with mold, bacteria and "foreign matter" in several areas and on equipment in the pharmacy designed to be kept sterile and sanitary. Inspectors found 83 vials of methylprednisolone acetate, the injectable steroid linked to the meningitis outbreak, that contained "greenish black foreign matter," while 17 contained "white filamentous material."
The report also noted a boiler that was leaking water that collected in puddles on the floor, gaps between sliding doors at the transition area between the pharmacy’s preparation room and warehouse, and contamination of storage areas for special clothing worn by pharmacy workers, while a mat in the transition area was described as "brown and soiled."
As of Friday, 24 people had died from meningitis linked to contaminated methylprednisolone acetate from the NECC, and 328 have become sick in 18 states, according to the Centers for Disease Control and Prevention.
FDA approves Teva’s Synribo for blood and bone marrow cancer
SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.
The FDA announced the approval of Teva Pharmaceutical Industries’ Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.
"Today’s approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML," FDA Office of Hematology and Ongology Products director Richard Pazdur said.
The drug is the second one approved for CML in two months. Last month, the agency approved Pfizer’s Bosulif (bosutinib) for patients for chronic, accelerated or blast-phase Philadelphia chromosome-positive CML who are resistant to or can’t tolerate other therapies.
Prime Therapeutics president, CEO to deliver keynote address at Therigy event
ST. PAUL, Minn. — The leader of pharmacy benefit manager Prime Therapeutics will be the keynote speaker at a specialty pharmacy conference Thursday.
Prime said president and CEO Eric Elliott would deliver the keynote speech, titled "Specialty Pharmacy Benefit – The Employer’s Perspective" at the first annual Therigy Specialty Pharmacy Leadership Congress in Orlando, Fla.
"It is vital to have a clear view into all components of specialty drug management and to be able to manage the constantly moving parts that play into it," Elliott said. "We need to connect to and coordinate with the health plan, the provider and the patient across the entire care continuum. In this way, we can close gaps in care that sometimes surface due to the complex nature of specialty management and the fact that several doctors and specialists may be involved in the patient’s overall care."