NECC facing scrutiny from Senator Richard Blumenthal, Gov. Deval Patrick, the FDA and lawsuits over contaminated steroid injections
The company who prepared the product, methylprednisolone acetate used for epidural back injections, is facing heavy scrutiny from government officials, regulators and at least one lawsuit to date, in response to the multistate fungal meningitis outbreak that has killed 15, and sickened nearly 200 as of Saturday.
Photomicrograph showing fine branching tubes of Exserohilum rostratum/ CDC
The New England Compounding Center (NECC) in Framingham, Mass. has drawn the ire of some prominent legislators. Most vocal is Democratic Senator Richard Blumenthal of Connecticut who is calling for a criminal investigation of the specialty compounding pharmacy.
In a letter Thursday to Attorney General Eric Holder, Blumenthal called for the U.S. Department of Justice to open a criminal investigation into the deadly meningitis outbreak, in particular, the NECC, its officers and employees, and others who should be held accountable.
Specifically, Blumenthal writes:
October 11, 2012
The Honorable Eric H. Holder, Jr.
The Attorney General
Washington, D.C. 20530
Dear Mr. Attorney General:
I know that you are as deeply troubled as I am by the tragic deaths and sicknesses caused by the apparent wrongdoing of the New England Compounding Center (NECC). I am concerned by the increasing amount of information available publicly and privately that indicates willful violations of law as well as basic standards of care by the NECC.
Senator Richard Blumenthal (D-CT) Photo/United States Senate
In light of recent reports that the NECC may have flagrantly and blatantly violated both state and federal law, directly contributing to contamination of steroid products distributed nationally across state boundaries, I request that the Department of Justice begin a criminal investigation of the company, its officers and employees, and others who should be held accountable. Relevant to considering possible criminal enforcement are the horrific consequences of this tragedy − at least 169 victims, including 14 deaths, as well as thousands still at risk during the incubation period for fungal meningitis. The NECC’s apparent history of problems is also pertinent. In 2006, the FDA issued a warning to the pharmacy to change its practices, which seems to have been disregarded. In Massachusetts, each compounded medication requires an individual prescription. However, this requirement was allegedly ignored by the NECC.
Previously, I have called for new legislative authority, giving the FDA enhanced inspection and enforcement power that would help prevent such tragedies in the future. In some respects, compounding pharmacies like the NECC, which often make drugs in large quantities without specific individual prescriptions, engage in manufacturing that is effectively lacking in oversight. They operate in a regulatory black hole − a legal netherworld − without the regulation generally applied to pharmaceutical drug makers assuring that products are safe and effective.
Regardless of any possible ambiguity regarding regulatory authority, this company seems to have committed misconduct, potentially involving misrepresentation, fraud, and other criminality. One claim is that the NECC knowingly misled governmental authorities, as well as health care providers. Such misstatements may constitute mail or wire fraud under state and federal law, and other possible legal violations.
I ask that the Department of Justice take the lead in coordinating investigations and prosecutions that may include state as well as federal authorities. Obviously, I have reached no conclusion as to criminal liability, but there seem to be sufficient, credible factual allegations and harm to warrant this request. I appreciate your interest and concern.
Sincerely,
Richard Blumenthal
United States Senate
In addition to Blumenthal, Massachusetts Gov. Deval Patrick accused the NECC of misleading regulators and operating outside its license by shipping large batches of drugs nationwide.
The Food and Drug Administration (FDA), who is taking some heat for failing to prevent the outbreak by closely regulating drug compounding companies such as NECC, is asking Congress for more power and authority over compounding facilities like NECC as Blumenthal describes above.
The FDA says, the limited authority it has now over these facilities, keeps it from preventing such outbreaks as the current one.
The litigation has begun too against the NECC. Minnesota woman, Barbe Puro alleges that in September, she was injected with a tainted batch of steroids from the Massachusetts-based New England Compounding Center, according to a CNN report.
Puro filed a lawsuit Thursday in Minnesota federal court against the Massachusetts pharmaceutical company.
