Ethan A. Huff
November 30, 2012
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:
This article was posted: Friday, November 30, 2012 at 5:53 am