During a hearing today examining the recent meningitis outbreak, Senator Mike Enzi (R-WY), Ranking Member of the Health, Education, Labor, and Pensions (HELP) Committee, said the catastrophic failure by regulatory agencies charged with protecting patients from unsafe drugs is unacceptable. Enzi said it is important to critically examine what happened in order to determine what needs to be done to prevent it from reoccurring.
"Thirty-two Americans have died and more than 400 have been sickened after receiving contaminated steroid injections produced by the New England Compounding Center (NECC). Additionally, approximately 14,000 patients in twenty-three states have were to potentially contaminated injections produced by the same pharmacy," said Senator Enzi. "We must break down this situation piece by piece to discuss how this tragedy occurred in order to prevent its repeat in the future."
Senator Enzi noted that the compounding pharmacy that caused these patient deaths and illnesses has a long history of problems with product safety and compliance with state regulations. Despite receiving multiple complaints about the sterility and safety of drugs compounded by NECC, state and federal regulators failed to continue to monitor NECC and take the steps that could have prevented the current situation.
"We will continue to investigate NECC's conduct and the oversight of state and federal regulators. We are in constant contact with the Food and Drug Administration (FDA), the Massachusetts Board of Pharmacy, and NECC and will leave no stone unturned." Senator Enzi said. "The HELP Committee worked very effectively in a bipartisan manner to reauthorize the FDA user fee legislation earlier this year and I am confident that we will continue to work together to address this problem and find a solution."