Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. BENNET. I thank the Senator from Iowa, the chairman of the HELP Committee, for his indulgence.

Yesterday I spoke about some of the process on the important issues of drug safety and making sure there is a good system for safer drugs, both in preparation and distribution. I know we seem to get close to reaching a resolution, which is tremendous. I have heard many of my colleagues praise different parts of the bill, which I will do as well in a minute. But I want to take 1 more minute again, while the chairman and the ranking member are on the floor, to recognize what an enormous accomplishment their leadership has resulted in, getting this bill to a close.

As I said yesterday, I think the work of the HELP Committee, both Democrats and Republicans, with the leadership of the chairman and the ranking member, is a model for this Congress. It is the reason why the quality of this bill is so high. We still have a few votes to go tomorrow, but people forget that it is rare to be working on a full extension of anything here. This has become the land of flickering lights, where we keep things on for 1 more month or 2 more months. Here we actually have a 5-year extension of this legislation. It is wonderful to be working in such a bipartisan and businesslike fashion. It is not lost on me how much work has been put into the bill by my colleagues on the HELP Committee, including the Presiding Officer, or the HELP Committee staff. I want to reiterate my thanks and gratitude for the work on the bill that will truly help patients and American families get the medical products they need when they need them.

That brings me to the subject of medical devices. Colorado is the sixth largest medical device sector in the country, with over 600 bioscience companies overall. We obviously need to strike a balance, as we think about this legislation, because as we speed the FDA approvals, we have to ensure that devices are safe. This year has represented a good-faith bipartisan effort among members on and off the HELP Committee to find policies that will empower the FDA to ensure safer devices and also ensure that our companies on the ground have more regulatory certainty and predictability.

The FDA has been upfront about the challenges the device center faces--reviewer turnover, young, less experienced reviewers, and management challenges. At the same time we have heard from venture capital investors who say that regulatory uncertainty at the FDA is a reason they have been hesitant about continued investments in the United States and thought about the future investment in Asia and Europe. The new medical device user fee will go a long way toward ensuring the FDA has the resources to provide safer, more effective medical devices in less time and with more predictability.

Over the course of a year we were also able to craft a balance of policies on both the innovation and safety side. This includes reinforcing regulations in place since 1997 that require the FDA to take the least burdensome approach to approving medical devices by not asking companies for unnecessary or unrelated information.

I see the Senator from Minnesota on the floor, and I thank her for her leadership on this piece of legislation. It also includes important safety provisions such as ensuring the medical devices have a tracking number so if there is any problem, doctors and patients can quickly know if their product is one that works.

I would like to say a word about drug shortage, which is a discussion issue every Member is hearing about in their States. In just the last year, the FDA was notified of about 220 drug shortages. We know that the amount of patients this affects is monumental. For cancer alone, over 550,000 patients have been currently affected by our national drug shortage crisis.

In Colorado, our patients and providers are extremely frustrated. A pharmacist at St. Mary's Hospital in Grand Junction said that he keeps a 2-page list of 50 drugs that he cannot get or can barely get a hold of, including 12 chemotherapy drugs.

I want to share a couple of constituent stories from my home State.

Dawn Gibbs from Long Mount, CO, wrote:

Dear Senator Bennet: I am contacting you to inform you of my grave concern of the national shortage of the preservative free cancer drug Methotrexate. My 2-year-old cousin receives this drug for her newly diagnosed leukemia of October 2011. Her doctors told her that they only have a 2 week supply left at their clinic. This drug keeps her leukemia from traveling to her brain. This shortage is life threatening to her and 3,000+ like her with this cancer.

I thank you for your assistance in this matter. I know that my little 2-year-old cousin cannot speak out on her own behalf, so I am honored to be her voice. I feel my voice will not be enough alone to make a difference, and I hope that you will be our voice.

Dawn Gibbs' voice is being heard on behalf of her cousin, just as patients all across the country are lending their voices to this important debate.

Carol Gill from Morrison, CO, wrote:

Dear Senator Bennet: I have stage 4 cancer. My current treatment regimen is doing a fine job of keeping the disease stable. This regimen includes a biweekly infusion of two generic drugs--5FU and leucovorin--and two other drugs still on patent. I receive treatment at the University of Colorado Hospital. My oncologist just called me to say that the University of Colorado Hospital is out of 5FU.

Today oncologists at the University of Colorado Hospital are calling their patients to tell them some or all of their cancer treatment must be suspended.

Thank you for taking this seriously and taking immediate steps to correct it.
Carol Gill.

My hope is that this Senate bill can give some reprieve to these Coloradans in desperate need of their lifesaving drugs.

The Senate bill would give the Food and Drug Administration the much needed authority to require drug manufacturers to report any discontinuance or interruption or other adjustment that would likely result in a shortage, especially those drugs needed to provide emergency care. It would also immediately create a task force that would create a strategic plan to address drug shortages and submit recommendations to Congress as well as study the effect on drug pricing as it relates to shortages.

The people in my home State and every one of our home States need us to provide solutions to this problem yesterday. They cannot wait any longer, nor should they.

I will say again that it is because of the leadership of the two people sitting here, the ranking member of our committee and the chairman of our committee, that we have been able to get this bill to the floor for a vote. I think we should take that vote tomorrow and move forward on behalf of patients all across this country and the bioscience community.

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