FDA

Files reveal FDA took 684 days to issue warning to deadly meningitis-linked pharmacy

Friday, November 30, 2012 by: Ethan A. Huff, staff writer
Tags: FDA, meningitis, pharmacy

eTrust Pro Certified

Most Viewed Articles
Popular on Facebook
BACK INTO THE CLOSET: Why U.S. reporters are not allowed to write about rainbow events in nations where being gay is still condemned
Depopulation test run? 75% of children who received vaccines in Mexican town now dead or hospitalized
A family destroyed: Six-month-old dies after clinic injects baby with 13 vaccines at once without mother's informed consent
Biologist explains how marijuana causes tumor cells to commit suicide
INVESTIGATION: Three days before Dr. Bradstreet was found dead in a river, U.S. govt. agents raided his research facility to seize a breakthrough cancer treatment called GcMAF
Companies begin planting microchips under employees' skin
BAM! Chipotle goes 100% non-GMO; flatly rejecting the biotech industry and its toxic food ingredients
ECONOMIC SLAVERY FOR ALL: While we were distracted with the Confederate flag flap, Congress quietly forfeited our entire economic future via fast-track trade authority
NJ cops bust teenagers shoveling snow without a permit
Chemotherapy kills cancer patients faster than no treatment at all
McDonald's in global profit free fall as people everywhere increasingly reject chemically-altered toxic fast food
March Against Monsanto explodes globally... World citizens stage massive protests across 38 countries, 428 cities... mainstream media pretends it never happened
Italian court rules mercury and aluminum in vaccines cause autism: US media continues total blackout of medical truth
SCOTUS same-sex marriage decision may have just legalized the concealed carry of loaded firearms across all 50 states, nullifying gun laws everywhere
Orthorexia Nervosa - New mental disorder aimed at people who insist on eating a clean diet
Vicious attack on Dr. Oz actually waged by biotech mafia; plot to destroy Oz launched after episode on glyphosate toxicity went viral
Nearly every mass shooting in the last 20 years shares one surprising thing? and it's not guns
Holistic cancer treatment pioneer Dr. Nicholas Gonzalez dies suddenly; patients mourn the loss of a compassionate, innovative doctor who helped thousands heal from cancer
Delicious
(NaturalNews) The Massachusetts-based pharmacy company responsible for the recent meningitis outbreak that left at least 34 people dead and another 490 injured is fighting back against the U.S. Food and Drug Administration (FDA), which it says took an inordinate amount of time in following through with issuing proper warnings about the company's questionable manufacturing practices.

According to recently uncovered documents, the New England Compounding Center (NECC) sent a letter to the FDA back in 2007 reprimanding the agency for taking nearly two years to follow up with inspections that first began back in 1999, and were later re-initiated in 2004. According to the letter, the FDA failed to both clarify and address any of the issues it had with NECC and its products in a timely manner.

"We believe that FDA's nearly two year delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products," wrote NECC co-owner and chief pharmacist Barry Cadden in the letter, date January 5, 2007. After receiving the letter, the FDA failed once again to respond until almost two years later, finally issuing a response on October 31, 2008.

In its response, the FDA admitted to Cadden that there had indeed been a "significant delay" throughout the entire process, but reiterated its "serious concerns" about the company's manufacturing process and operations. According to a recent statement by FDA spokeswoman Erica Jefferson, the agency had numerous internal matters to deal with at that time, including discerning its appropriate role in the regulation of large-scale drug compounders like NECC.

The FDA also defended itself by claiming that Cadden refused to cooperate with the agency on numerous occasions in years prior, including back in 2004 when the FDA found several marketing and packaging violations at the company. Rather than meet to discuss the issues, Cadden stonewalled, according the agency, and even became hostile -- and such behavior continued throughout the course of many years.

Even if Cadden's concerns about the FDA's warning delays were valid, his company still appears to have been directly responsible for shipping tainted steroid shots to clinics all across the country, a heinous oversight that should not have occurred no matter how poorly the FDA handled its inspection process over the years. A federal judge also recently determined that individual lawsuits against NECC are free to move forward, despite requests by NECC that they be delayed.

Sources for this article include:

http://www.reuters.com

http://www.naturalnews.com

http://www.businessweek.com

Follow real-time breaking news headlines on
FDA at FETCH.news
Join over four million monthly readers. Your privacy is protected. Unsubscribe at any time.
comments powered by Disqus
Take Action: Support NaturalNews.com by linking back to this article from your website

Permalink to this article:

Embed article link: (copy HTML code below):

Reprinting this article:
Non-commercial use OK, cite NaturalNews.com with clickable link.

Follow Natural News on Facebook, Twitter, Google Plus, and Pinterest

Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

GET SHOW DETAILS
+ a FREE GIFT

Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of NaturalNews.com, the internet's No. 1 natural health news site. (Source: Alexa.com)

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.