Meningitis outbreak linked to pharmaceutical compounding has long history

Oct 24 2012

News outlets report that the FDA released a list of customers - including some major hospitals - of the New England Compounding Center. But the FDA later "found technical problems" and withdrew the list, promising to repost it as soon as the data are corrected.

The New York Times: Documents In Meningitis Case Show Complaints In 1999
The Massachusetts Department of Health released hundreds of pages of documents on Monday detailing a history of violations at the New England Compounding Center, whose tainted medicine has caused a nationwide meningitis outbreak. The documents include dozens of complaints from as early as April 1999, less than a year after the company began as a compounding pharmacy in Framingham, Mass (Tavernise and Pollack, 10/22).

The New York Times: U.S. Concern Over Compounders Predates Outbreak Of Meningitis
A year before people began dying of meningitis caused by a tainted drug from a compounding pharmacy in Massachusetts, the Food and Drug Administration worried that compounders across the country might be selling another substandard drug, one possibly made with unapproved Chinese ingredients (Bogdanich and Tavernise, 10/22).

The Boston Globe: State To Review Pharmacy Monitoring
Republicans have suggested that a demonstration project providing more funding to the program is helping to cover up the cuts from the health law. The administration provided 1,300 pages to Issa last week. ... A spokesman for Governor Deval Patrick said in a statement Monday that his administration is investigating regulators' "troubling" choice of PSI, a selection he said was made during Governor Mitt Romney's administration. Also on Monday, federal officials released a list of almost 1,300 New England Compounding customers, including 75 Massachusetts hospitals, doctors offices, and clinics. Late Monday night, the Food and Drug Administration ­removed the list, saying it had found technical problems and "the data are incorrect" (Kowalczyk and Lazar, 10/23).

Kaiser Health News: Capsules: Updated: FDA Temporarily Removes List Of Hospitals, Providers That Received Products From Mass. Compounder 
Just hours after posting it Monday, the Food and Drug Administration removed from its website a list of hospitals and doctors that had received products from the compounding pharmacy now at the center of the fungal meningitis outbreak, saying data may be incorrect. The agency said it is working to correct the list and will repost once it is completed. ... The original list included more than 1,000 hospitals, clinics and doctors nationwide, including some well-known facilities such as Brigham & Women's, Beth Israel, the Mayo Clinic Health System, Children's Hospital Boston and the Dana Farber Cancer Institute (Appleby, 10/22).

CQ HealthBeat: Appropriators Urge Action From HHS, VA In Meningitis Outbreak
Two Democratic leaders on the House Appropriations Committee asked the administration to take action to ensure the safety of compounded medications. ... [The lawmakers said] the departments of Health and Human Services (HHS) and Veterans Affairs (VA) should take their own steps. Rosa DeLauro of Connecticut and Sanford D. Bishop Jr. of Georgia noted that VA medical centers have bought products from companies linked to the meningitis outbreak. At last count, the CDC had identified 297 cases of fungal meningitis linked to the New England Compounding Center's injectable steroid drug (Ethridge, 10/22).

Politico Pro: Compounding Pharmacies Bill In Sight
Legislators are moving swiftly on proposals to expand explicit FDA oversight of large-scale compounding pharmacies in the wake of the deadly fungal meningitis outbreak, but staffers and lobbyists say it will be tough to get a bill to the floor during the crowded lame-duck session. With 23 deaths as of Sunday linked to the outbreak, there is mounting pressure on Congress to act. But before lawmakers pass new legislation, they expect hearings in both House and Senate committees into the tragedy linked to tainted steroid injections (Norman, 10/22).