Corker, Alexander Ask FDA For Clarity On Oversight Of Pharmacy Linked To Fungal Meningitis Outbreak

Friday, October 12, 2012

In response to the deadly, nationwide outbreak of fungal meningitis linked to steroid injections distributed by the Massachusetts-based New England Compounding Center, U.S. Senators Bob Corker and Lamar Alexander, Friday sent a letter to FDA Commissioner Margaret Hamburg asking for clarity regarding existing laws governing oversight of compounding pharmacies like NECC and information about any inspections of NECC and actions taken since the FDA warned the center in December 2006.

"We are writing to express our deep concern about the recent outbreak of fungal meningitis in patients throughout the country, and especially in our home state of Tennessee," wrote Senators Corker and Alexander in their letter.  "Our hearts go out to those who have been sickened, those who have passed away, and their families, and we are hopeful that all patients affected are identified and receive the necessary care. We understand that the FDA has been working closely with the Centers for Disease Control and Prevention, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of this outbreak of fungal meningitis, including a thorough review of the operations of the New England Compounding Center.

“It is our hope that this investigation will help us identify the root causes of the outbreak and what actions may be necessary to prevent this from happening in the future.  To help us and our staff better understand this complex situation, we would appreciate you or your staff providing us with answers to the following questions:

What authority does the FDA have over compounding pharmacies under current law?  To what extent does the FDA exercise this authority?

What is the nature of the FDA’s relationship with state boards of pharmacy? How does the FDA coordinate with these boards to regulate compounding pharmacies?

How does the FDA define a compounding pharmacy? Is this definition used by the state boards of pharmacy when granting licensure? 

Has the FDA ever inspected NECC’s facility?  If so, what dates did such inspections occur? 

What actions have been taken since your agency sent a warning letter to NECC in December 2006?  To your knowledge, what actions has the Massachusetts Board of Pharmacy taken since that letter?” 

A complete copy of the letter is below:

October 12, 2012
The Honorable Margaret H. Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg:
We are writing to express our deep concern about the recent outbreak of fungal meningitis in patients throughout the country, and especially in our home state of Tennessee.  Our hearts go out to those who have been sickened, those who have passed away, and their families, and we are hopeful that all patients affected are identified and receive the necessary care. 

We understand that the FDA has been working closely with the Centers for Disease Control and Prevention, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of this outbreak of fungal meningitis, including a thorough review of the operations of the New England Compounding Center.

It is our hope that this investigation will help us identify the root causes of the outbreak and what actions may be necessary to prevent this from happening in the future.  To help us and our staff better understand this complex situation, we would appreciate you or your staff providing us with answers to the following questions:

What authority does the FDA have over compounding pharmacies under current law?  To what extent does the FDA exercise this authority?

What is the nature of the FDA’s relationship with state boards of pharmacy? How does the FDA coordinate with these boards to regulate compounding pharmacies?

How does the FDA define a compounding pharmacy? Is this definition used by the state boards of pharmacy when granting licensure?

Has the FDA ever inspected NECC’s facility?  If so, what dates did such inspections occur?

What actions have been taken since your agency sent a warning letter to NECC in December 2006?  To your knowledge, what actions has the Massachusetts Board of Pharmacy taken since that letter?

We will continue to monitor the situation and anxiously await the results of your investigation and our questions.  We thank you again for all of your ongoing efforts to address these infections, and we look forward to working with you to ensure the safety of patients in Tennessee and across the country.

Lamar Alexander                                                                                Bob Corker
United States Senator                                                                         United States Senator


Chattanooga Heroes Run/Walk Scheduled For July 16

Last  July 16 , Chattanooga was changed forever following the tragic shootings at the Armed Services Recruiting Center on Lee Highway and the U.S. Naval Operational Support Center and Marine Corps Reserve Center on Amnicola Highway.   One year later , thousands of supporters will participate in the Chattanooga Heroes Run/Walk to honor and remember those ... (click for more)

Morning Pointe Residents 'Pay it Forward' At Steak N' Shake

Residents at Morning Pointe of Chattanooga at Shallowford think they have an interesting and kind way to have fun - paying for strangers' orders at the Steak N' Shake on Gunbarrel Road during Half Price Happy Hour.  The assisted living residents say they find enjoyment going through the drive-thru in the Morning Pointe bus and buying their favorite milkshakes, while paying ... (click for more)

CBL & Associates Stockholder Accuses Chattanooga-Based Mall Owner Of Security Fraud

A stockholder of CBL & Associates is suing the Chattanooga-based mall owner in Chattanooga Federal Court, claiming its officials artificially inflated the value of the company's stock. Tommy French, of Baton Rouge, La., brought the action against CBL, President Stephen Lebovitz and Vice President Farzana Mitchell. He claims that CBL officials made false and misleading ... (click for more)

Carmody Found Guilty Of First-Degree Felony Murder; Sentenced To Life In Prison

Patrick Carmody was sentenced to life in prison after being found guilty of first-degree felony murder and especially aggravated robbery in Judge Barry Steelman’s courtroom on Friday. He was charged with the slaying of 21-year-old Chance LeCroy on Sept. 9, 2010. The state’s account of the incident claimed that Carmody, Ronald Pittman, and Billy Bob Partin traveled ... (click for more)

Case Handled Like Any Other? - And Response

It is interesting that Chief Fletcher would deem the handling of the Mayor's encounter as typical or normal. Is the Chief asking the public to believe that all misdemeanor domestic violence arrests include a 4-hour taped interrogation, and delayed reporting after a visit to the Chief’s house. Of course, we believe that Chief Fletcher. April Eidson * * *  I ... (click for more)

Roy Exum: The Best Speech This Year

Just 24 hours after Donovan Livingston gave The Student’s Speech at Harvard University’s Graduate School of Education convocation on Wednesday, it had been viewed over 3 million times and shared 75,000 times on Facebook. It is already considered, far and away, as the freshest view on race and education in ages and its viral journey is burning across the Internet. His talk was ... (click for more)