Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Resumed

Floor Speech

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Ms. KLOBUCHAR. Mr. President, I rise today to talk about the importance of passing the Food and Drug Administration Safety and Innovation Act, more commonly known as the user fee reauthorization bill. This bipartisan legislation would reauthorize the user fee program for the medical device industry, incredible important in my home State of Minnesota, as well as the pharmaceutical industry.

This bill represents over 1 year of negotiations between the FDA, Congress, and the industry. I believe we have achieved a good balance in terms of the improved performance, incentives through increased accountability, more meaningful goals, important process improvements, better metrics, and additional resources.

Not only does this legislation include the user fee agreements negotiated between the industry and the FDA, it also includes several reforms that will benefit the entire health care system and improve public health. The bill will make medicines safer for children. It will protect the global drug supply chain. It will improve access to safe, innovative medical devices and treatments, and it will tackle the drug shortage crisis that is spreading across the country.

On Monday I talked about the work I did leading the effort on drug shortages. I am so pleased that Senator Harkin and Senator Enzi included this provision in this bill. But I also believe it is important to talk about the guts of the bill; that is, the improvements with the FDA and the work that needs to be done.

I commend the HELP Committee, on which the Presiding Officer serves, and specifically Chairman Harkin and Ranking Member Enzi for being dedicated to ensuring that this

process was open, transparent, and bipartisan.

At a time when Congress has been deeply divided, this legislation shows we can still overcome our differences and address the needs of the country through strong bipartisan cooperation.

For the State of Minnesota, passing this bill is vital to our continued economic growth and strength. With strong institutions such as the Mayo Clinic and the University of Minnesota and innovative companies such as 3M and Boston Scientific and Medtronic and St. Jude's, Minnesota's job numbers have fared better than the national average, with our unemployment rate now more than 2 1/2 points below the national average; that is, 5.6 percent compared to 8.1 percent.

That is also attributed to the fact that Minnesota has one of the largest and most dynamic pockets of medical device companies in the country. I mentioned a few of the big ones, but there are also many small thriving companies. Many of our biggest innovations have come from the small companies, adding up to about 400 firms employing over 35,000 people across our State.

We cannot forget that it was Minnesota that brought the world one of the biggest innovations in the country. I am not talking about the Post-It note, although it is true that did come from our State. I am talking about the pacemaker, which we give thanks to a company called Micronic that started out in a garage in Minneapolis.

So our roots run deep in this industry. But medical technology is just not important to Minnesota, it is important to our country, putting billions of dollars in our economy each year. It is important to the world. The devices we make in the United States do not just save lives locally, they save lives globally.

As we look at potential exports and how we are going to reach the President's goal of doubling our exports in 5 years, and how we are going to get out of the economic rut we have been in, a lot has to do with exports, new markets, and a rising middle class in countries such as China and India where people are finally going to the hospital, will use our medical devices, and will bring jobs to the United States.

But that only works if these medical devices get approved and if we are able to make them, have the skilled workers to make them, and can beat our competition, basically, of companies in other countries that may be growing unless we make sure we have a proper approval process here that keeps things safe but also moves smoothly and quickly. The kind of meaningful, innovative work that our country needs more of is this kind of work. It is high-tech manufacturing, and that is what we need more of in this country.

As cochair of the bipartisan Med-Tech Caucus in the Senate, I have had several conversations with FDA about ways to improve this regulatory environment. I have introduced bills, as has the Presiding Officer, and looked at the importance of putting in things that guarantee safety but also make sure we improve the process so we get more innovation and more jobs in this country.

If we are not careful, as we know, continents such as Europe--if they move faster than us, as they have in some instances, then we have a problem because then the venture capital money goes to Europe. With China requiring country-of-origin approval, we can have a situation where companies decide they can get things done quicker if they move their business to a place such as Europe and then get the approvals in place so they can sell in China. We do not want that to happen.

The FDA will now be responsible for total review time goals. That is an important part of this bill. This measures the time from submission of a new application to the time the technology is available to patients. Putting the FDA on the hook for this measure will streamline the approval process and help get innovative and lifesaving devices and treatments to patients.

In addition to improved review times and performance standards, the one aspect I hear about the most from our medical device companies, both small and large, is they need better communication between the FDA and industry. This agreement takes significant steps to address this issue by opening clear lines of discussion before a submission is made. This helps provide companies with clear direction and requires the FDA to stick to their commitments.

It also requires interaction between the FDA and the applicant during the review process to keep everyone on the same page and avoid miscommunication and costly delays. The agreement also requires the FDA to work with companies to find the best path forward if goals are not met. Most importantly, this legislation will give the FDA the tools necessary to meet these goals.

This agreement provides for $595 million in user fees over the next 5 years. This is meant to provide for additional reviewers, enhanced training, and increased efficiencies to help improve FDA performance and help patients get access to the most innovative and safest products available.

But a positive user fee agreement does not guarantee success. We must also focus on the execution and administration of these new resources and new guidelines. That is why I introduced a bipartisan bill with Richard Burr of North Carolina, a Republican, and Michael Bennet of Colorado, a Democrat, that would significantly improve the regulatory process.

It would tackle three important things related to the approval process: First, it would increase efficiency by strengthening the agency's least burdensome principle, which has been continuously overlooked by FDA's reviewers. The average time to approve an application has increased 43 percent from the 2003-to-2007 time period to 2010. This simply is unacceptable.

Second, it would improve conflict-of-interest provisions making it easier for the FDA to recruit top-line experts to take part in the review process.

This would allow the FDA to protect the integrity of the review from undue conflicts of interest but also take advantage of available expertise.

Third, it would require the FDA to use an independent consulting organization to assess the management processes at the Center on Devices. This would encourage the agency to consider the impact of its decisions on innovation, while also considering the balance between the risk and benefits of the new devices.

I am thankful that, in working with Senators Harkin and Enzi, we were able to include these improvements in this bipartisan legislation.

Equally as important to improving the regulatory process at the FDA, this legislation also includes my provision on drug shortages. I have come to the floor several times in the past year to talk about the crisis as it has impacted individuals all across our country. There is the story of a little 4-year-old boy who was going to get treatment for his leukemia, and his parents were put in a panic. He was a little bald boy with a smile on his face. They found out that the drug he needed, Cytarabine, was missing in action; it was not in the hospital, not in the pharmacy. They were actually looking into booking flights to Canada so that he could get the drug treatment he needed. At the last minute someone located the drug.

Sadly, that doesn't happen in many cases across the country, where we have had people come forward and talk about missing breast cancer treatments and people who have died because drugs were not available. The fact that physicians, nurses, and pharmacists are spending hours and hours of their time, which should be spent with patients, looking for pharmaceuticals is an outrage.

We know there are many reasons for this. We are glad the industry was willing to work with us to come up with at least a short-term patch here, where the FDA will be alerted as a result of the provisions in this bill when the pharmaceutical companies believe there is going to be a shortage. Right now, they are only required to do it for orphan drugs. Now they will be required to do it for all drugs. These can be shortages as a result of raw materials that are not there, as a result of mergers in the pharmaceutical industry, or shortages as a result of a decision not to produce a drug because it may not be as profitable or shortages because of all kinds of things that could happen in the course of commerce.

The key point here is that when the FDA finds out early, they have been able to avert drug crises. They can find another manufacturer in our country or abroad, and they get the drugs in; they have done it over 200 times in 2 years. This will give them more tools to be able to avert what is an escalating crisis in this country where we are seeing more and more shortages of drugs on a weekly basis.

As I said, I am glad this bipartisan provision--and Senator Casey introduced it originally with me, and we have had support from Senator Collins and others, and our working group worked out an agreement to get this provision in the Senate bill, with good prospects in the House under the leadership of Congresswoman DeGette from Colorado.

I thank my colleagues for their work for two reasons. One, this is important for medical devices and pharmaceuticals in terms of getting fast approval, and that is better for patients and for jobs in America as we become a country again that makes products and invests in goods that we export to the world. To do that, you need the regulatory process working.

Second, this bill is good because it contains a drug shortage provision to finally get at something that is long overdue, and that is the escalating crisis of drugs that have gone missing, which should be in the hands of patients across this country. Now we put them in a much better position in terms of being able to find alternative drugs in either our country or others, so we don't have these shortages we are seeing every day. That is why I think it is very important that we get this bill done soon.

Mr. President, I yield the floor and suggest the absence of a quorum.

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