Two members of Congress are calling for an investigation by the U.S. Department of Justice (DOJ) into whether the New England Compounding Pharmacy breached any federal rules or regulations. The specialty pharmacy is in a negative spotlight because of its link to the recent fungal meningitis outbreak. Our rare fungal meningitis lawyers at Pintas & Mullins Law Firm hope that that the outbreak will soon be controlled.
Criminal investigators from the FDA were recently at the pharmacy as part of an extensive investigation by various federal and state agencies. They reportedly discovered fungus in over 50 vials produced by the Massachusetts compounding pharmacy. However, they did not say conclusively say whether this was the true source of the contamination.
Last week, the Massachusetts governor opined that the compounding pharmacy could possibly have misled regulators and carried out work that was outside the range of its state license.
In a letter to the DOJ, a state representative indicated that the list of products the pharmacy recalled seemed to include controlled substances which are under the jurisdiction of the Drug Enforcement Agency. He also said that pharmacies that compound or sell controlled substances need to register with the agency, which this particular pharmacy did not.
He also added that pharmacies are only allowed to market controlled substances directly to patients with particular prescriptions. However, pharmacies that register with the agency as suppliers or manufacturers are exempted from the rule. This may require an additional DEA investigation to confirm whether the company that breached Massachusetts state law also breached federal law pertaining to controlled substances.
In related news, Reuters recently reported that the number of deaths from the nationwide meningitis outbreak rose to 19. Of the four new deaths, two were in Tennessee and one each in Florida and Virginia.
As per CDC updates, the number of fresh cases of fungal meningitis is now at the 240+ mark. The increasing number of infections and deaths shows that this major national outbreak is yet to be controlled. This is despite emergency measures to withdraw the medications from the pharmacy and stop the use of its products.
The FDA may have some tough questions to answer. Though it is restricted authority to control compounding pharmacies such as NECC, it flagged serious breaches at the company just 6 years ago.
Recently, a U.S. House of Representatives panel examining the outbreak gave the FDA until the end of the month to hand over whatever documents it had pertaining to the pharmacy, including communications with the agency’s commissioner and state regulators from 8 years ago.
Last week, FDA representatives informed the panel that NECC assured the agency of its compliance back in 2007. However, government officials were not sure whether the agency did anything further to guarantee that corrective measures were enforced.
The compounding pharmacy at issue here is authorized to develop particular
doses of approved medications, based on a doctor’s advice and to
meet a specific patient’s need. Since there is evidence that the
company shipped huge quantities of the drugs all over the US, local authorities
consider it a violation of state laws.
Meningitis is a serious infection, and the type of fungal meningitis that is spreading nationwide can be fatal. Nearly 14,000 steroid injection patients may be at risk of this deadly disease.
If your loved one believe that you may have contracted fungal meningitis from an NECC product, you need to consult a doctor immediately. Upon confirmation, a rare meningitis lawyer can help you fight back against the compounding pharmacy.