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Public Statements

Flood Insurance Reform and Modernization Act--Motion to Proceed

Floor Speech

Location: Washington, DC


Ms. MIKULSKI. Mr. President, we have just exchanged some parliamentary lingo to essentially say we are going to vote shortly to see if we can pass the Food and Drug Administration Safety and Innovation Act, and do it without a filibuster. I hope we can vote for cloture--not to muzzle, not to have a gag rule, but so we can move expeditiously on this bill.

Every single Member here should be proud of what we have accomplished in this FDA Safety and Innovation Act. We have accomplished three major objectives: No. 1, if the legislation is passed--and it is a conference agreement between the House and the Senate--we will be able to move pharmaceuticals, biotech products, and medical devices into clinical practice faster while maintaining our ethical standards around public safety.

No. 2, we can demonstrate we can work together and we can govern. This is the result of the Senate working on both sides of the aisle. Now, with the House, through the conference report, we show we can work between the Senate and the House.

In this time of prickly politics and political posturing when more gets said than done, we can show we cannot only pass legislation but legislation that makes a difference in people's lives. We will also show we can do it in a way that we will not only have a regulatory framework but something in which the businesses cooperated so we will have regulation without strangulation. We will have regulation that acts in the interest of public safety but does not stifle, shackle, or impede good business practices. Wow. Isn't this what we have been talking about?

I am very proud of having been a member of the Health, Education, Labor, and Pensions Committee that worked on this bill. I am also very proud of the fact that FDA is in my State. In a nutshell, we are passing something called PDUFA and other UFAs. PDUFA stands for the Prescription Drug User Fee Act.

There will be others that we will talk about which relate to bio user fees and medical device user fees and generics.

This bill was originally enacted in 1992, and the reason for that was at that time there was an unduly long wait for patients to have access to new medicines and new medical devices. It often took close to 3 years to even review a drug application. So Congress went to work with then-President Bill Clinton to say where the pharmacy could agree that, first of all, they would pay user fees to support FDA's drug review program. It is a true public-private partnership. When we look at the funding for FDA, the people who make pharmaceuticals, biotech, and medical devices pay 60 percent of the FDA budget. That is $712 million. The remainder comes from Federal appropriations--40 percent, which is $473 million. So there is a partnership between those businesses that profit--and we want them to do so, without profiteering--and, at the same time, government pays its share.

Since 1992, this legislation has been an enormous success. More than 1,500 new medicines have been approved, including treatments for cancer, infectious disease, and cardiovascular disease. It has decreased review times from more than 3 years to 1 year and a few months now.

In order to make sure we had the right perspective, we not only held excellent hearings in the Senate, but I went out around my own State. I am so proud of my State. We are the home of life sciences. We have NIH there, which does incredible basic research. We actually have FDA, which reviews food safety and drug safety. At the same time, we are the home to a robust group of biotech companies. I wanted to listen to those biotech companies. When I went out, I said to them: Tell me how your government is helping you and tell me how your government is impeding you. Tell me where you want your government to get out of the way and where do you need a more muscular government. Well, we heard quite a bit from them. The first thing they told me is they need a Food and Drug Administration because when they are approved for public safety and efficacy in the United States of America, they can sell their products anywhere in the world. It often means countries--small countries, countries of modest means with limited GDP that could never afford an FDA--know that if the United States of America says it is OK for their citizens, any other country in the world knows it is OK for theirs. So it is very good to be able to export these products with confidence and reliability. This is fantastic, in their minds.

Second, they said they needed more help from FDA not only to expedite but they wanted better communication.

They also needed to be able to incentivize development for those rare diseases we often hear about, where there are small markets but big investments to achieve in it. They outlined the fact that they needed to be viewed not in an adversarial way but a collaborative way. Well, thanks to business sitting down with FDA, and business sitting down with Members of Congress, we have been able to do exactly that. We have improved efficiency, predictability, the regulatory environment, and, at the same time, insisting on safety and efficacy.

This is going to be great for patients. Millions of Americans rely on drugs and biologics and on medical devices. If we are going to improve health care and rein in the cost of health care, we have to use drugs, biotech products, and medical devices that improve lives and extend lives.

If we fail to authorize this legislation, we are going to be in big trouble. How are we going to be in big trouble? Well, first of all, we will have to give notice to FDA that there are going to be layoffs. That means we would have to send out notices in July telling 4,000 people: Look, we know you are the best and the brightest and we want you to have integrity as well as regulatory sensibility and a great deal of scientific competence, but we couldn't get our act together so you are going to be laid off.

Hello. We want these people out there, helping America be able to provide health care in a way that is safe and efficacious.

Again, as I said, if we don't act, thousands of FDA people will be laid off. It is not about government. If those people are laid off, it means the review process for every single drug that is now in the pipeline will come to a halt. So we are hurting patients, thousands of people who need new drugs; new ways of helping them, whether it is for that dread C word--cancer--or diabetes, which takes so much of our national budget to manage chronic illness.

What about the breakthroughs on this epidemic of Alzheimer's we have or autism? We need all the help we can develop. If America is going to continue to be America the exceptional, we have to do an exceptionally good job of making sure we produce some of the newest and most reliable drugs, biotech, and medical devices.

This is why I think we have good legislation. Is it perfect? No. But is it pretty close to it for what business and government and providers--the doctors themselves--say we need? Absolutely.

I urge my colleagues today, when we vote on this motion to proceed on cloture to have in mind--whether a colleague is a Democrat or a Republican--that we don't make the perfect the enemy of the good; rather, we think of all those people to whom we talk every day. We talk to them at townhall meetings and out there with diners, and they say: You know, my little boy has leukemia; my mother has breast cancer; my dear father who stood up for me is facing the ravages of Alzheimer's. We need breakthroughs. We need help, then, for our private sector, so it can go global and create jobs in this country and well-being in other countries around the world. We have to be able to do it.

I am also pleased this bill combats drug shortages, improves the safety of the drug supply chain, and makes permanent those special considerations that require that children's needs are being met with both medical devices and prescriptions, either in terms of dosage or that a device actually fits them.

I wanted to come to the floor to lay this out. I am very proud of FDA, and I am very proud of the Congress, including Senator Harkin and Senator Enzi, who pulled us together. We have the right legislative framework. Now let's act and do it in a way we can all be proud of.

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


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