Mikulski, FDA Commissioner Hamburg and Dr. Kasey Thompson of American Society of Health-System Pharmacists Based in Maryland Participate in Hearing on Deadly Meningitis Outbreak

Meningitis outbreak, originating from infected steroid injections has resulted in 32 deaths nationwide, including one in Maryland

November 15, 2012

WASHINGTON – U.S. Senator Barbara A. Mikulski (D-Md.), a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today participated in a hearing entitled "Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak." The hearing focused on the recent meningitis outbreak which originated from steroid injections from the New England Compounding Center (NECC) that were infected with fungus. To date, the outbreak has resulted in 32 deaths nationwide, including one in Maryland.  

"By all accounts, there are many people and agencies to blame… But blame offers no relief to those who have lost a loved one. What we must do today is figure out how to ensure that is never happens again," Senator Mikulski said. "It is the responsibility of this Committee to get to the bottom of what went wrong, and figure out if we have the right regulatory framework with the right enforcement teeth in place to prevent another crisis."  

Senators heard from health experts including Dr. Kasey Thompson, Vice President, Office of Policy, Planning and Communications at the American Society of Health-System Pharmacists (ASHSP) in Bethesda, Maryland. Dr. Thompson has published numerous articles, editorials and book chapters on medication-use safety and quality including co-editing Medication Safety: A Guide for Health Care Facilities with Dr. Henri R. Manasse, Jr. in 2005. Dr. Thompson has previously testified before the U.S. Senate, House of Representatives and a variety of federal agencies.  

The hearing included two panels of witnesses. The first included Dr. Beth Bell, Director, National Center for Emerging & Zoonotic Infectious Diseases, CDC; Dr. Peggy Hamburg, Commissioner, FDA; and Dr. Lauren Smith, Interim Commissioner, Massachusetts Department of Public Health. The second panel included Dr. Marion Kainer, Director, Healthcare Association Infections & Anitmicrobial Resistance Program, Tennessee Department of Health; David G. Miller, Executive VP & CEO, International Academy of Compounding Pharmacy; and Dr. Kasey Thompson.  

Senator Mikulski's full remarks, as prepared, follow:  

"Thank you Chairman Harkin and Ranking Member Enzi for calling this hearing to investigate the causes of this avoidable crisis, and to engage stakeholders to find a solution. To date, the actions are by one compounding pharmacy in Massachusetts: The New England Compounding Center. The New England Compounding Center (NECC), which has left thirty-two people dead from fungal meningitis. And in Maryland, twenty-three confirmed cases and one death. This should never have happened.  

"By all accounts, there are many people and agencies to blame; from the NEC themselves to the Massachusetts Board of Pharmacy. But blame offers no relief to those who have lost a loved one. What we must do today is figure out how to ensure that is never happens again. This is an inquiry, not an inquisition.  

"Hospitals, doctors, and patients are increasingly relying upon "compounded drugs" which are supposed to be made on an individual basis to respond to a patient's unique health needs. For instance: if a patient is allergic to a certain ingredient in a drug, a compounding pharmacy can make the drug without that ingredient. Or, if a child needs a smaller dosage strength, a compounding pharmacy can do that.  

"Today, between one and three percent of the United States' prescription drug market is made up of compounded drugs. A majority of pharmacists compound medicines for patients and nearly every hospital compounds drugs. These drugs and the hospitals and pharmacies that make them serve an important role in our ongoing efforts to provide more personalized medicine and health care.  

"The problem is that where there is need, there is greed. Compounded drugs are supposed to be made on an individual basis for an individual patient and provided only with a prescription from a doctor. It has become clear that certain compounding facilities, like the New England Compounding Center (NECC), were blatantly and flagrantly violating these rules. And why? To make a profit? Not only was NECC mass producing drugs and dispensing across state lines without prescriptions, they also knowingly disregarded sterility tests and prepared drugs in unsanitary conditions. And what have been the results of NECC's actions? Hundreds are sick, twenty-three in Maryland, and dozens dead, including one in Maryland.  

"NECC never should have made drugs in unsanitary conditions, mass produced these drugs, or provided these medicines without prescriptions. But, it has become evident that regulatory frame work in place to catch and prevent these illegal and dangerous actions failed us.  

"NECC had a long history of repeated violations. In 2002, the FDA inspected facility after adverse event reports cited NECC for sterility issues. In 2006, the FDA sent NECC a warning letter stating that they were acting like a drug manufacturer. In July 2012, just a few months before the most recent outbreak, the Colorado Board of Pharmacy sent a letter to the Massachusetts Board of Pharmacy complaining that the NECC was compounding without prescriptions. The Massachusetts Board of Pharmacy never responded to that letter. How this facility was able to continue mass-producing and dispensing drugs nationwide, is beyond me.  

"We cannot undo the tragedy cause by the NECC's actions, but we must find a way to prevent this from ever happening again. It is the responsibility of this Committee to get to the bottom of what went wrong, and figure out if we have the right regulatory framework with the right enforcement teeth in place to prevent another crisis.  

"Compounding pharmacies are primarily regulated at the state level. We must determine whether or not this is appropriate. And, if so, how can state do a better job monitoring, overseeing, and regulating their facilities.  

"The FDA's authority over compounding pharmacies is limited and unclear due to several challenges in federal court. It is not feasible for all compounded drugs to be FDA approved. This would be far too expensive for individual drugs for individual patients. But we must determine whether or not it is appropriate to clarify and/or expand the FDA's authority over some of these facilities so we can better draw the line between pharmacy and manufacturer.  

"However, any discussion of expanded FDA authority must be accompanied by a frank and honest discussion about resources and personnel available to carry out additional responsibilities. We cannot continue to heap new responsibilities on FDA without a corresponding increase in resources and personnel to carry out this work.  

"I look forward to hearing from today's witnesses about their recommendations for improving the safety of our nation's drug supply. In particular, I look forward to hearing from FDA Commissioner Hamburg – who we ask to do so much, with so little; from ensuring the safety our nation's food supply, to protecting us from counterfeit imported drugs.  

"And Dr. Kasey Thompson from the American Society of Health-System Pharmacists based in Bethesda, MD. I have read Dr. Thompson's testimony and he offers some thoughtful and innovative ideas for how we can work to right this wrong and ensure this never happens again.  

"Thanks again to Chairman Harkin and Ranking Member Enzi."