Emily
Editor, Senior Moderator
Re: US - 34 dead, 490 infected with fungal meningitis in 19 states
Re: US - 34 dead, 490 infected with fungal meningitis in 19 states
http://www.cnn.com/2012/10/16/opinion/carome-meningitis/index.html
Re: US - 34 dead, 490 infected with fungal meningitis in 19 states
http://www.cnn.com/2012/10/16/opinion/carome-meningitis/index.html
Deadly meningitis outbreak was completely avoidable
By Michael Carome, Special to CNN
updated 4:07 PM EDT, Tue October 16, 2012
Editor's note: Dr. Michael Carome is deputy director of the Public Citizen's Health Research Group.
(CNN) --
[snip]
A key player at the federal level deserving a significant amount of blame is the FDA.
Loud alarm bells were sounded on December 4, 2006, when the FDA issued warning letters to the New England Compounding Center and four other compounding pharmacies, directing them to stop producing standardized versions of medications that, according to the agency, were being "marketed for general distribution rather than responding to the unique medical needs of individual patients." the center was cited for violations of FDA regulations in marketing four different drugs, including repackaged doses of the cancer drug Avastin into syringes for treatment of macular degeneration.
News: Injectable drugs from Mass. facility suspect
Clearly, the FDA considered the center and the other compounding pharmacies to be engaged in drug manufacturing. The pharmacies, like any other drug manufacturer, were therefore subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.
However, following its warning letter, the FDA subsequently dropped the ball and failed to take the actions necessary to ensure the center adhered to these drug standards, which are essential for protecting the health of patients. For whatever reason, whether inattentiveness or lack of compliance and legal resources, by not aggressively enforcing the regulations related to large-scale drug manufacturing and interstate commerce, the FDA allowed the company to shift its wide-scale manufacturing and interstate distribution operation to injectable steroids.
On Thursday, the FDA attempted to deflect criticism for its failures by asserting that it lacked authority to take action earlier. This flies in the face of the agency's long-stated position that it had legal authority over such activities and its prior enforcement activities against the New England center and multiple other compounding pharmacies. While no one wants to be viewed as being responsible for a preventable public health catastrophe, American citizens should express their outrage and demand that all parties responsible for this tragedy -- including the FDA -- be held accountable.
Otherwise history will repeat itself.