Compounding pharmacies often escape strict scrutiny since they do not come under the norms that govern other drug companies, which are subject to rigorous manufacturing standards. Compounding pharmacies employ more outdated manufacturing methods and sometimes the hygienic manufacture of medicines is compromised. Drug recall lawyers push for more inspection and scrutiny of compounding pharmacies.
In a startling revelation, congressional investigators recently reported that state health regulators in Massachusetts and the U.S. in general were fully aware of the possibility that steroid treatments from the New England Compounding Center (NECC) could cause an aggressive meningitis outbreak way back in 2002.
The U.S. House of Representatives Energy and Commerce Committee said that the complaints made about methylprednisolone acetate were one of the reasons for the joint inspections of the New England facility that were conducted by the state and federal government in the years 2002 and 2003. This gives the first sort of proof that potential health hazards with the drug produced by the New England pharmacy were known to, or at least suspected by, health officials long before the contaminated drugs were officially linked to the fungal meningitis infection in early 2012.
The House committee is in charge of the rare fungal meningitis investigation. There is intense pressure on the FDA to intensify its scrutiny of NECC and other pharmacies like it that function outside the federal safety regulations that govern drug manufacturers, yet produce massive quantities of drugs sold all over the nation. Steroid treatments with the NECC drug administered for neck and back pain have led to 23 fatal fungal meningitis cases of the 294 total reported cases.
The treatment has been administered to at least 14,000 people. Other health issues cannot be ruled out too, which is why health officials are carrying out other investigations on this drug along with others produced by the New England pharmacy. The U.S. House of Representatives Energy and Commerce Committee reported that public health officials in Massachusetts informed it about the inspections conducted in 2002 and 2003 in a closed-door briefing.
The Republican committee chairman and panel members were notified that the NECC signed a consent agreement in 2006 to settle complaints based on an FDA investigation concerning the effects of preservative-free methylprednisolone acetate. That year, the FDA sent a warning letter to the NECC regarding the health risks posed by other drugs it manufactured.
Adverse incidents resulting from the steroid injection were reported by
the FDA through its MedWatch system, which was set in place to report
serious issues with drugs as well as medical devices. The committee also
warned of the possibility of the NECC functioning as a drug manufacturer
rather than a compounding pharmacy operating outside the federal safety
rules for drug manufacturers. This possibility was raised following the
observations made during the inspections.
One of the most serious issues for our pharmaceutical litigation attorneys is how the NECC continued to function in the manner that it did, even 10 years after the methylprednisolone acetate warnings and six years after the warning letter from the FDA. Major health risks were clearly suspected at this point, putting the public in serious danger.
Meningitis lawyers at Pintas & Mullins Law Firm will continue staying up to the minute on all meningitis-related developments. Victims or loved ones of the victims of the rare meningitis attack caused by contaminated steroid injections are urged to contact one of our experienced meningitis outbreak lawyers immediately.