by:Jeff S. Gibson, Attorney
The House Energy & Commerce subcommittee held a hearing on November 14, 2012 to gather the facts surrounding the fungal meningitis outbreak that has sickened over 475 people and killed 33 people across 19 states. The big question on lawmakers’ minds is ‘could this outbreak have been prevented?’ However, this is rhetorical because the answers that are really being sought are more about ‘who should have done what and how can we make sure this never happens again?’
It is no surprise that when Barry Cadden, the co-owner of the New England Compounding Center, was questioned about unsterile conditions of the labs where the drugs were made that he declined to answer and cited the Fifth Amendment. He avoided answering questions and stated “Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment.”
A history of state and federal investigations of NECC was shared during the hearing. NECC had violated regulations for sterile compounding and laws regarding sales of compounded drugs dating as far back as 2002. The FDA alone had issued two citations for unsafe production and packaging along with one warning letter issued in 2006. The warning letter cited two practices at NECC– the creation of commercially available drugs and conducting marketing activities such as free samples to physicians– which are prohibited by compounding pharmacies.
The Massachusetts Board of Pharmacy (MBP) had investigated over twelve complaints and issued four advisory letters and informal reprimands of NECC. The first complaint against NECC was filed within the first year of its operations. MBP entered into a few consent agreements with NECC over the years to correct violations that were discovered. By signing these agreements about making suggested improvements to compounding protocols and sales practices, NECC was able to avoid formal hearings and investigations by MBP.
Lack of Cooperation
It is almost shocking to read the November 12 memo from the subcommittee on Oversight and Investigations which details the many of the exchanges that Mr. Cadden had with the FDA and MBP over the years. Reports from both agencies demonstrate Mr. Cadden’s lack of cooperation and transparency in providing information and answering questions regarding drug compounding and distribution. In many of these reports, he contradicted himself when the agencies followed up issues cited issues in previous investigations.
In March 2002, the FDA received two reports of adverse events related to drugs made by NECC. The FDA requested the MBP to assist in an investigation of NECC. On the second day of this inspection, Mr. Cadden directly challenged the FDA and questioned its jurisdiction and authority to be at his pharmacy and refused to provide requested documentation. The MBP continued to follow up with NECC after the FDA’s official report of this inspection and did find that improvements were made. However, it was recommended by one MBP investigator that NECC receive a formal reprimand based on the company’s history of related prior concerns.
As the investigation continues to uncover details, it feels like a blame game is going on. The public along with lawmakers want to know why someone didn’t step up sooner to put a stop to NECC’s production of potentially hazardous drugs. Senator Pat Roberts, who introduced the Safe Drug Compounding Act which was defeated in 2007, pointed his finger at the FDA and asked why the agency didn’t act sooner. While David Miller, CEO of the International Academy of Compounding Pharmacies, agreed with Mr. Roberts and said, “The FDA knew they were doing this 10 years ago and still did nothing to stop it.” This is particularly interesting given the fact that the IACP had spent over $1 million in the past 10 years lobbying against legislation that was aimed at giving the FDA the authority to inspect compounding facilities as well as restrict the distribution of compounded drugs across state lines.
However, I think Senator Tom Harkin said it best, “This comes down to resources. We continually ask the FDA to more and more and more”. Dr. Margaret Hamburg of the FDA agrees that the FDA could do more in its efforts to keep patients safe from products manufactured by compounding pharmacies. She also suggested that additional staffing and funds would be necessary to make this a reality. Let’s hope that lawmakers choose to resolve the issue sooner rather than later.
Fungal Meningitis Outbreak Blame Goes to: NECC, Massachusetts Board of Pharmacy, or FDA?
by:Jeff S. Gibson, Attorney