DeGette Opening Statement at Hearing on Compounding Pharmacies and the 2012 Fungal Meningitis Outbreak
In her opening statement, Rep. DeGette noted that the Colorado State Board of Pharmacy discovered the NECC's deficiencies, back in 2011, and issued a cease-and-desist order to stop the company's practices.
Today's hearing focused on the Food and Drug Administration (FDA) and the regulatory framework that oversees the compounding pharmacies, as well as the history surrounding this issue.
Rep. DeGette's opening statement, as delivered, is below:
• Mr. Chairman, thank you for holding today's hearing.
• I know I join you and the rest of the Members of this Subcommittee in expressing our deepest condolences to those who have been affected by the tragic events in Boston yesterday, and I know we are all thinking about the victims.
• M. Chairman, obviously this fungal meningitis outbreak is a serious situation and our committee needs to understand the facts about how and why the meningitis outbreak occurred, and what we can do to prevent it in the future.
• I think this investigation has the potential to become part of the great bipartisan oversight history of this Committee.
• I know that good investigations don't always result in legislative change. But in this case, we can use this investigation to help us identify the legislative changes –if any – that we need to help us avoid tragedies like this in the future.
• As hospitals, clinics and other medical providers outsource more of their compounding, a number of compounding pharmacies have sprung up and frankly they have been operating below the regulatory radar screen.
• A spotty pattern of state regulations and enforcement, combined with conflicting federal law, have made that even worse.
• Mr. Chairman, I want to talk about some of the facts we have uncovered as we have spent the last five months investigating the New England Compounding Center, the FDA, and the deadly fungal meningitis outbreak caused by contaminated compounded drugs.
• First, as we all can stipulate, the owners and operators of NECC, the compounding pharmacy, ran a shoddy, fly-by-night operation and jeopardized the lives of thousands of people.
• Second, for several years prior to the outbreak, the FDA received warnings about the company from its own inspectors, from State Boards of Pharmacy, and from whistleblowers.
• The FDA received warnings about – and seriously considered investigating – Ameridose, NECC's sister company, just a few months before NECC began to ship the deadly steroid products.
• One of the states that discovered these deficiencies was my home state of Colorado, and in fact, the State Board of Pharmacy issued a cease-and-desist order to stop the company's practices.
• I am confident that we can all agree on those two facts on both sides of the aisle.
• But I also hope we can agree on a third fact that will help explain why FDA was unable to effectively regulate this company. Then I hope we can act together to fix the problem.
• Mr. Chairman, in October 2012, this Committee requested thousands of pages of documents from the FDA about their interactions with NECC and their approach to regulating compounded drugs.
• The Democratic staff has reviewed these documents and yesterday released a supplemental memo with key findings. I'd like to ask that this memo be made part of the hearing record.
• The pattern of documents from 2002 through last year demonstrates that, under two Administrations and over 10 years, the FDA has not been aggressive enough in attempting to regulate compounding pharmacies.
• The question is "Why"?
• It is a serious and legitimate question to ask what the agency should have been doing, and could have been doing over those many years.
• And I know from your opening statement that you intend to do just that.
• I also look forward to hearing what specific solutions Commissioner Hamburg and the FDA believe would help them protect the American people from another outbreak.
• Because these documents show us that the FDA has been grappling with a law that is broken and we need to help fix that law and keep the American public safe.
• But we also need to look at how court decisions impacted the FDA's ability to regulate.
• Mr. Chairman you say the FDA is hiding behind judicial robes, but in fact, Court decisions are the law of the land, and what we have here in the wake of the serious meningitis outbreak last year, is a patchwork of laws.
• We have two judicial circuits that are coming up with different decisions about the authority of the FDA which is causing some of these compounding pharmacies – not all of them, but some – to resist any regulatory efforts by the FDA.
• As the FDA has been attempting to better regulate this situation since these issues came out, there have been instances of compounding pharmacies refusing to provide FDA access to records or facilities.
• As we learned during our food safety investigation and some of our other investigations in this Committee, if you have an allegation of little black particles in some of the vials of the pharmaceuticals, the FDA and its cooperating agencies need the ability to work fast.
• But if you have a company that says you can't come in here and makes the FDA go to court, that's not a speedy or desirable resolution.
• So Mr. Chairman I'm looking forward to hearing from Commissioner Hamburg about, number one, what the agency has done to improve this situation and to improve enforcement;
• And number two, what the agency thinks that we need to do legislatively to fix this law so this will never happen again.