November 14, 2012

WASHINGTON – Today, U.S. Rep. Diana DeGette (CO-1) presided as Ranking Member of the Oversight and Investigation Subcommittee’s hearing on the fungal meningitis outbreak that has killed 32 people to date and caused 438 cases of meningitis, spanning 19 states.  The outbreak was caused by contaminated steroid injections manufactured at the New England Compounding Company. In her opening statement, Rep. DeGette noted that in 2011, the Colorado State Board of Pharmacy determined that NECC was distributing unlicensed and unregistered drugs in the state, and issued a cease-and-desist order. Unfortunately their warnings went unheeded.

Rep. DeGette’s full statement is below:

Thank you, Mr. Chairman, for holding this important hearing on the very day we return.  This is an important public health crisis and I’m pleased we’re addressing it on a bipartisan basis.

The contaminated steroid injections sold by the New England Compounding Company have caused 438 cases of fungal meningitis spanning 19 states; 32 people have died, and I’m afraid that number could climb.

We have four witnesses today to help us examine how this could have happened.  I’m very eager to hear from the FDA and the Massachusetts Board of Registration in Pharmacy, the agencies with primary regulatory authority over NECC, just how we got here.  I want to hear from Mr. Barry Cadden about how our earth his company could have been so irresponsible.

And, I’m looking forward to hearing from Ms. Joyce Lovelace, the wife of one of the first victims of this tragedy.  I want to join the Chairman, Ms. Lovelace, in expressing my deepest condolences for your loss.  I thank you for coming today, and for your courage in sharing your story with us.

Mr. Chairman, the facts we have uncovered so far in this investigation reveal frightening failures on multiple levels. There’s clearly lots of blame to go around to a lot of people.

Mr. Cadden repeatedly failed to ensure that NECC and its sister companies were following appropriate safety rules and guidelines.

Again and again, reports of problems with the facility were brought to the attention of the Massachusetts Board of Registration in Pharmacy, who failed to act.

The Board was informed of problems – via complaints or from its own inspections in 1999, 2002, 2003, 2004, and even just this past summer. But somehow, NECC was able to keep its license, avoid significant penalties, and continue its operations until tragedy struck all across the nation.

We also need to hear an explanation from FDA.

Just like the Massachusetts Board, FDA inspectors and officials were repeatedly informed of problems at NECC.   But the strongest action taken by the FDA was a warning letter sent to the company in 2006 – a letter that appeared to have very little effect.

The FDA tells us that they were hobbled by questions about whether they had the legal authority to address the problems at NECC.  If this is true, Mr. Chairmen, it is a problem that demands this full Committee’s immediate attention.

Over 30 people have died from this meningitis outbreak because too many signals about the risk from NECC products were missed. One of those missed signals came from my home state of Colorado.

In 2011, the Colorado State Board of Pharmacy determined that NECC was distributing unlicensed and unregistered drugs in the State and issued a cease-and-desist order.

But this was all that Colorado officials could do – and it was not enough to stop NECC’s actions.

Colorado officials notified Massachusetts Board of Registration in Pharmacy officials…and the Massachusetts officials did nothing.

The Colorado State Board of Pharmacy did the right thing.  But the system failed.  NECC did not improve its operation.  The FDA did not act.  And Massachusetts did not act.

Mr. Chairman, for a long time we’ve all had a Norman Rockwell vision of the pharmacists who manufacture the drugs our families rely upon – The kindly, old gentleman in the white coat, mixing prescriptions for the little child with an illness.

Unfortunately this tragedy makes clear that large corporate compounding pharmacies are operating unchecked by appropriate safeguards, even as American families trust their lives.

Mr. Chairman, let’s work together now to make sure that this crisis is not repeated.