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


Grocery Bar Hosts Fall Family Event To Benefit Inaugural CureSearch Cancer Walk In Chattanooga

The Southside’s Grocery Bar hosted a fall celebration event to raise funds and awareness for the upcoming CureSearch for Children’s Cancer Walk Chattanooga. Many area Chattanoogans enjoyed the beautiful weather on Saturday painting free pumpkins, and enjoying freshly-prepared organic foods such as pumpkin muffins, Halloween cookies and hot cider. Shoppers were offered the chance ... (click for more)

Bradley County EMS Reviews And Drills For Infectious Diseases

With the growing concerns of infectious disease, Bradley County EMS is being proactive and reviewing their infectious disease protocols. Current policies and procedures are being reviewed and updated. Personal protection equipment has been updated as well to provide the best protection to the EMS responders. Emergency responders are exposed to a variety of contaminates on ... (click for more)

2 People Shot Saturday Night On Carousel Road

Two people were shot Saturday evening on Carousel Road. At  9:11 p.m. , Chattanooga Police responded to 1406 Carousel Road on a call of a person shot. One victim on the scene suffered minor injuries.  Another victim was transported by personal vehicle to a local hospital. The s econd victim suffered non-life-threatening injuries.  The suspect ... (click for more)

Teenager Killed In ATV Accident Thursday Night

Damon Lee Jones, 15, was killed Thursday night in an ATV accident in Walker County. It was reported he was riding with a 17-year old, when they tried to enter a church parking lot, but ran into a cable barrier. The accident happened on Dunwoody Road in LaFayette. The other rider, identified as Timothy J. Wallin, was not injured.   (click for more)

Tom Dugan Was A Good Man

Tom was my boss for most of my 36 years at Carta.  At the ceremony where I was awarded my 30-year service award, Tom said, "Don disagrees with 85% of my decisions, but I wish I had 80 more employees just like him." This kind of indicates our relationship. When I asked him to help with my plans for a reunion for the group of Veterans that I served with in Vietnam, he quickly ... (click for more)

Roy Exum: A Veterinarian’s Horse Sense

I suspect you’ve heard by now that a doctor in New York City, who volunteers with “Doctors Without Borders,” just got back from the African nation of Guinea on October 17 – last Friday – and on Thursday tested positive for the deadly Ebola virus. Luckily, he came in actual contact with only a few people but he reportedly rode a subway, took a taxi, went on a three-mile run and ... (click for more)