http://www.chattanoogan.com/2012/10/12/236257/Corker-Alexander-Ask-FDA-For-Clarity.aspx
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
Filed under: General Problems
The deaths associated with this are a real tragedy. The other tragedy is that the majority of these compounding pharmacies do great work and provide a much needed service to the market and are being demonized. The larger companies actually centralize the duties. that would otherwise be performed by thousands of clinicians with various levels of experience and standards. This could potentially result in more deaths and issues related around their ability to produce a sterile and potent admixture. Wouldn’t you rather get these items from someone with a proven process? Every other company in the market expressed concerns about these two and their actions in the market. You would be dumbfounded if you saw the number of pharmacist today in hospitals around the country that still want to use these companies and believe this will blow over. They still don’t see the tie between the two companies or just don’t want to. They are willing to believe anything so they can save their pretty penny. Many and I mean many actually said that they were not concerned with quality but only in saving money. We have bigger healthcare issues if this is their mentality. Also, someone should look into the hiring practices of these two companies. If it is archived anywhere, you can see that they preferred to hire people with no healthcare experience through medical sales management. I’ll leave it to you to surmise why. These companies had tactics by which they would sue anyone that sued them and do so expeditiously to scare you off of the suit. Just look at their lawsuits.