Lawmakers on Capitol Hill have promised to update federal regulations, namely with the Food and Drug Administration, that would bring pharmaceutical drug compounding labs under the agency’s eye in the future in hopes of avoiding situations like the current deadly outbreak of fungal meningitis that’s claimed 32 lives and sickened hundreds more.
According to a Reuters report, members of the U.S. Senate Health, Education, Welfare and Pensions Committee said late this week that they’ll introduce legislation that aims to place compounding labs like the embattled New England Compounding Center under the watch of the FDA, not just state pharmacy boards which obviously failed to act on more than a decade of evidence that showed manufacturing processes there, specifically, had gone afoul of the law.
The filthy conditions at New England Compounding Center likely led to the deadly outbreak of fungal meningitis. Early last month, the Massachusetts-based company issued a recall on three shipping Lots of its methylprednisolone acetate epidural steroid injection because they may have been contaminated with a fungus. These injections are prescribed in the treatment of back pain and inflammation. The company sent more than 14,000 vials to at least 70 pain management and health care centers in 23 states before issuing the recall.
FDA testing eventually confirmed the presence of a bacteria in 50 of the vials the agency tested. Soon after the recall, the company issued a recall on all its products produced recently and shut its doors as local, state, and federal investigators began to look for sources to the contamination. They didn’t have to look far as conditions inside NECC’s facility were sure signs that the company’s facilities were to blame.
Standing water from leaking pipes and other traces of contamination were found everywhere investigators looked. As these inquiries unraveled, more details on the company and just how long it has been skirting safety regulations were made public.
In the latest details, it has been learned that the FDA and the Massachusetts Board of Pharmacy were aware of the conditions at NECC since at least 2002 and that some of its products in the past have been linked to adverse reactions from recipients but were never reported to regulators. The problems never escalated to the severity as they did this year with the epidural injections and members of Congress aim to make sure it doesn’t happen again with the introduction of new laws that would place it and other drug compounding labs under the watch of the FDA fully, at least enough that it could prevent future widespread outbreaks such as this.
One wonders that with all the problems facing the FDA – especially the criticism that the agency has a difficult time tracking foreign manufacturers of drugs – if these new prospective laws for the agency will be enforced as they should. In many ways, the FDA is as ill-equipped to enforce its laws as state health and pharmacy agencies.