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


Senate Health Committee To Hold Zika Hearing On Feb. 24 At 10 A.M.

Chairman Lamar Alexander and Ranking Member Patty Murray (D-Wash.) announced Thursday the Senate committee overseeing public health policy will hold a hearing on the Zika virus on Wednesday, Feb. 24, at 10 a.m. Chairman Alexander said: “Americans have many questions about the Zika virus, as we have watched news of its spread through Central and South America, as well as ... (click for more)

Dade County And The Arts - Dancing With Breast Cancer

In 2006, I was diagnosed with breast cancer and had bi-lateral mastectomies. Now, almost 10 years later, I look back at how dance and art transformed my life-challenging situation into beauty. With the help and support of my friend and artist Mary Petruska, I decided not to do reconstruction. From a beautiful drawing of wild passion flowers by Mary, we went to tattoo artist Skip ... (click for more)

Underground Fire Closes Several Downtown Streets

An underground fire closed several downtown streets late Saturday afternoon. At approximately 5:20 p.m., the Chattanooga Fire Department responded to a reported fire in a man-hole at the corner of Chestnut Street and W. 8th Street. When fire companies arrived on the scene, they found black smoke coming from an underground electrical service line. The man-hole cover had been ... (click for more)

16-Year-Old Who Was Shot In The Head In East Ridge Dies

 Monserrate Ferrer, the 16 year old who  was shot in East Ridge on Friday , has died. Investigators will meet early next week with the Hamilton County District  Attorney's Office to discuss the case. The shooting that involved two juveniles was at the 4200 block of Bennett Road. Responding officers found a 16-year-old boy in the bedroom with a single ... (click for more)

The City Failed To Watch The Chattanooga History Museum Dollars

The tell tale signs of the History Museum's folly have been evident for years. When I was a former member of City Council I interviewed Dr. Daryl Black, Ph.D. to determine if I should argue for or against the annual funding of his organization. His interview, the multi-year history of administrative non-performance (despite consistent repetitive funding), and a review of the organizational ... (click for more)

Roy Exum: Vote ‘No’ On Vouchers

I fully believe that public education in Hamilton County is the single most important opportunity that challenges us today. Over the weekend the new website for the ‘Chattanooga 2.0’ initiative went up and every parent who has a child in our public system should make it “required reading.” You can find it at www.chatt2.org. Please sign up for updates because a lot of us need to ... (click for more)