Food and Drug Administration Safety and Innovation Act

Floor Speech

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Ms. KLOBUCHAR. Mr. President, this bill means so much to my State. I spoke earlier today about the need to improve the approval process at the FDA, and this bill will speed that up with the agreement reached between industry and the FDA on the fees. I thank the Senator for his leadership on that issue.

We have literally tens of thousands of employees in our State who have incredibly good jobs in the high-tech industry. This is a huge potential export. It is already an export, but even more could come if we do this right as we look at the growing middle class in countries such as China and India who are going to the hospital and using medical devices. So this bill is speeding up that process but still keeping the very important safety standards in place, which couldn't be more important--as well as for patients who have been waiting for lifesaving treatment. So I thank the Senator for that.

I also thank the Senator for including, as Senator Bennet referenced, my drug shortage provision. We worked on that for 2 years. We gathered support as the years went on.

I thank Senator Harkin for the hearing we had on that bill and for the work of his staff in bringing people together. We got Senator Casey's and Senator Collins' provisions in this bill.

We all know what has been going on. As several Senators have mentioned, we are talking about 4-year-old boys with leukemia whose parents find out they have no cancer treatment drug and literally are put into a panic, so they book flights to Canada so this little child can complete his treatment, or the woman with breast cancer who has to call around for Prudoxin and is then faced with the ethical dilemma that she explained to us that she knew she was taking it away from another patient. That should not happen in the United States of America, and this early notification of the FDA, as we have seen, has been very positive.

Over 200 drug shortages have been averted because of the early notification with orphan drugs in the last few years, so this provision will truly make a difference. I thank the Senator for including that.

I am here to talk about another matter the two Senators have been involved in negotiating. These are bills that Senator Schumer, Senator Grassley, and I have been working on. We each had one of the three bills that covered different synthetic drugs.

My drug bill covered 2C-E, which is a synthetic hallucinogen, which, sadly, is something a young man died from taking in Minnesota. There was actually a murder prosecution because of it, and, again, we have seen it go like wildfire through our State with these synthetic drugs. Senator Portman and myself and Senator Grassley will be offering this amendment, and I thank the Senator for his work on it. I also encourage my colleagues to support this amendment, and I hope it will pass overwhelmingly.

As members of the Judiciary Committee, Senator Grassley, Senator Schumer, and I have been working on this, as I mentioned, for years. There have been reports from every State in the country of people acting violently while under the influence of these drugs, which leads to death or injuries to themselves and others. While taking these drugs, people can experience elevated heart rates and blood pressure, hallucinations, seizures, and extreme agitation, which is dangerous, but they are also dangerous to themselves.

Up in Moorhead, MN, with the Fargo sheriff, we did a forum. A group of people were sitting in the front row. I actually thought they were there to object to our provisions. They were there to support them because they had lost a loved one who thought he was taking what he considered to be synthetic marijuana, and it turned out to be very different from any marijuana. It turned out to be much stronger, and he ended up hitting a tree and killing himself. They were sobbing while telling their story.

Until 2006, I was a Hennepin County attorney. During my time there we just didn't have this as an issue. We can see how quickly it has changed. Listen to these numbers. In 2011 poison control centers across America received more than 13,000 calls about synthetic drugs. How many calls did they get in 2010? They only got 3,200. Look at that--3,200 to 13,000 in just 1 year. In Minnesota there were a total of 392 calls to poison control relating to synthetic drugs in 2011 compared to 107 in 2010--a tripling of calls about this problem in just 1 year.

This all hit home, as I mentioned in my State, with the tragic death of a 19-year-old man, Trevor Robinson, in Blaine, MN, when he overdosed on 2C-E. It is a synthetic hallucinogen. Another young man was thought to have shot himself in Minnesota while under the influence of synthetic drugs. We can imagine the pain of these families, and that is why I introduced a bill to add 2C-E and similar drugs to the substance list so they will be treated in the same manner as other banned drugs they claim to represent.

I am also a cosponsor of the two bills authored by Senators GRASSLEY and SCHUMER. All three of these bills are contained in the amendment we are offering with Senator Portman. These drugs can kill, and if we don't take action, they are going to become more and more prevalent. They are available on the Internet. The Federal Government has to make clear that they are illegal. That is what is going on today because people literally buy these drugs that have numbers like 2C-E. They don't really know what they are. They get them, and they turn out to be deadly. That is what happened in Blaine, MN.

I am hopeful that we vote to ban these drugs as part of the debate on this bill. We have seen what happened in Minnesota. We know the DEA has been taking action on its own, and they temporarily banned some of these drugs, but most of the substances covered in our three bills have not been banned, including all of the substances in my bill. That is why, in fact, we are offering this amendment.

On the State level, roughly 40 States have banned some synthetic drugs, including my State, where a major law regarding synthetic drugs took effect in July. We need a Federal law. This crosses State lines. A lot of it is done on the Internet. We cannot simply have this State by State, and passing a Federal law will help create the partnership we need to send a strong message that we need to eradicate these substances.

I am pleased this amendment is being offered. We need to get it done now, ban these drugs, and make a clear statement that these drugs are illegal.

I again thank Senator Harkin and Senator Enzi for working it out so we can offer this amendment, and also my colleagues, Senators PORTMAN, SCHUMER, and GRASSLEY, for their hard work. I know we are committed to getting this done.

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