Speeches & Floor Statements

Floor Remarks of U.S. Senator Lamar Alexander (R-Tenn.): FDA

Posted on May 23, 2012

Mr. President, I thank the majority leader for bringing up this bill. He and the Republican leader have put on the floor a piece of legislation that affects nearly every American family. This will not have the fireworks some things we do have, because we have a lot of agreement on it, which is one reason it is on the floor. It has gone through the committee. Senator Harkin and Senator Enzi have worked carefully with all of the Republicans, all of the Democrats on the committee, and many other people on a complex piece of legislation for a year, to bring to the floor the Food and Drug Administration Safety and Innovation Act - a bill that is likely to succeed.

We take our medicines for granted. During the Civil War, the Capitol was used as a hospital -- this Capitol. Two thousand cots were set up in the House and Senate Chambers and the Rotunda. The first group of wounded arrived from the Second Battle of Bull Run and later from Antietam in September of 1862. Those soldiers did not have the benefit of antibiotics or other modern medicines that we take for granted today, and that contributed to a horrible number of deaths in the Civil War.

Still, as the 20th century dawned, disease cast a long shadow over the United States of America. A child born in 1900 could expect to live an average of 47 years. Infectious diseases took many children before they reached their teens. In 1900 pneumonia and influenza were the leading causes of death, followed by tuberculosis and diarrhea.

Physicians had few weapons to fight diseases. The medicines at the time included such things as mercury for syphilis and ringworm; digitalis and amyl nitrate for the heart; quinine for malaria; and plant-based purgatives. For most of human history, diabetes meant death, but insulin was introduced in 1923 commercially, and within a few years enough insulin was being produced to meet the needs of diabetes patients around the world.

It is hard to remember this, but vaccines began to be commercially produced only during the time of World War I. It was not until the time of World War II that we saw the introduction of widespread and effective antimircrobial therapies with the development and mass production of penicillin. Since then, the sky has seemed to be the limit.

Half of Americans take at least one prescription drug every day. One in six takes three or more. Many take over-the-counter medicines. It is a real miracle what has happened in terms of our lives with the introduction of medicines, and we rely upon the Food and Drug Administration to keep those medicines safe and effective, which is what this legislation is about.

I would like to renew my compliments to Senator Harkin and Senator Enzi for bringing this bill to the floor in a condition where they have already worked out most of the issues. This bill is complex. It is long. It has 11 titles. It will help safe and effective drugs, medical devices, and biosimilar products get to the market and, more importantly, get them to the market more quickly so people who need help can use these medicines and devices.

We are reauthorizing two user fees. These things have absurd names. The Prescription Drug User Fee Act is called PDUFA, and the Medical Device User Fee Modernization Act is called MDUFMA. There are two new ones, which are GDUFA and BSUFA. It is really absurd. I promise to never again use those phrases for these user fee programs. But they are critically important programs that give the Food and Drug Administration needed resources to review new medically necessary products.

For example, there is the Better Pharmaceuticals for Children Act. It is a part of what we are doing this week. I cosponsored it with Senators Reed of Rhode Island, Murray, and Roberts. I thank them for the ability to work with them.

This makes permanent the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. One is an incentive, and one requires pharmaceutical companies under certain circumstances, when they develop new drugs for adults, to figure out the effect that those drugs will have on children. Too often, we do not know the answer to that, and the drugs are either ineffective or can have bad results. It also reauthorizes the Pediatric Medical Device and Safety and Improvements Act to promote pediatric medical device development.

Another critical part of the bill has to do with the medical device approval process. The United States is a world leader in medical devices. In Tennessee we have lots of them, especially in Memphis. We need to improve the regulatory process. There are many who believe the FDA is over-regulating medical devices. That has a negative effect on the industry's ability to raise capital and create jobs. It does not make those devices any safer in the United States than they are in Europe. This will help address those problems. For example, it will allow customization of medical devices for small populations -- that means five people or fewer -- without going through a very burdensome approval process, and it changes the humanitarian device exemption to encourage and incent the development of devices to treat patients with rare diseases -- that would be groups of patients of fewer than 4,000 people.

There is another problem that is addressed in this legislation. It is the generation of antibiotics dealing with antibiotic resistance. We know there is a growing problem with antibiotic resistance as bacteria continuously mutate and evolve in their resistance to the drugs and the medicines we develop. While efforts have been made to preserve existing antibiotics, drug development has not kept up with the pace. These changes will provide meaningful market incentives and reduce regulatory burdens.

In addition, I am very pleased with the results of our work in dealing with drug shortages. That is a part of this bill. It will give the FDA additional tools to help prevent drug shortages and require FDA to look internally at regulations to see if the FDA is making the problem worse. Senator Casey and I worked together on a review of Federal initiatives to combat prescription drug abuse and to issue a report on those. Tennessee, my State, ranks second in the Nation for prescription drug use. Our Governor, Bill Haslam, and our legislature took action this year to deal with that. We intend to help them.

In closing, I would like to commend Senators Harkin and Enzi. I see the Senator from Washington on the floor. I do not want to take much more time because I know she is about to speak. She has been integrally involved in the development of this legislation over the last year, especially the Better Pharmaceuticals and Devices for Children Act. I mentioned that a little earlier. It incentivizes drug manufacturers to study their products and how they affect children, and in return, they get to keep the exclusive use of those products for a little while longer. That means they do not go to generic quite as quickly. That has been tried in this legislation since it was first authorized and reauthorized and reauthorized. It has worked. It has been a very good example of an innovation in legislation that has achieved the desired result.

The Pediatric Research Equity Act gives the FDA authority to require pediatric studies in some cases and the Pediatric Medical Device Safety and Improvement Act promotes the development of pediatric medical devices.

So the importance of the legislation is it takes a big step forward in making it clear what drugs that are created for adults will do when offered or provided to children. Currently, just under half of the drugs prescribed to children have been studied and labeled for children, but that is a significant improvement over where we were when these programs started fifteen years ago. Children's bodies react very differently to medicines. Children are not just small adults. Sometimes side effects are different. Physicians have to guess what dosages are appropriate, whether a therapy that might be effective for an adult is also effective for a child. Sometimes there are examples of overdosing or previously unknown side effects. In one case in Tennessee in 1999, seven babies were prescribed an antibiotic to treat whooping cough. They became so seriously ill, they needed stomach surgery. The CDC -- Centers for Disease Control -- later linked their illness to the antibiotic, which had never been tested in young children. Children differ widely in sizes and growth rates, so for medical devices doctors must either jerry-rig devices or be forced to use a more invasive treatment. Prior to the passage of these laws that we are working on today, and reauthorizing, 80 percent of drugs used for children were used off-label; that is, we did not really know how they affected children. Now we can use those drugs -- half of our drugs today -- safely and effectively because we do know that. The Best Pharmaceuticals for Children Act

is the carrot that FDA uses to encourage pediatric studies, while the Pediatric Research Equity Act is the stick to mandate studies. Together these two laws have been a success. According to the Institute of Medicine, as of October 2010, the FDA has approved 425 labeling changes as a result of studies or analyses done under these laws. In 1975, only about 20 percent of drugs prescribed to children had been studied and labeled for children, in 2007 that number had risen to about one-third, and today it is roughly half.

The Pediatric Medical Device Safety and Improvement Act was enacted in 2007 to encourage manufacturers to bring more pediatric devices to the market and strengthen FDA post-market surveillance of devices used in children. This law allows manufacturers to profit under the humanitarian device exemption for devices specifically designed to meet a pediatric need affecting fewer than 4,000 children per year. In addition to three humanitarian device exemption pediatric products, GAO reports that 15 new devices have been approved for children since 2007.

I am happy to come here today to join with Senator Murray, Senator Harkin, Senator Enzi, Senator Reed of Rhode Island, and Senator Roberts to offer what I believe is a piece of legislation that affects nearly every American family. It takes one more step in the dramatic story of how we have gone from a country with almost no medicines to a country in which almost everyone takes some medicine and a situation where the lifetime of the average American has increased from 47 years of age to 78 years - its present level today.

I see the Senator from Washington on the floor. I wish to recognize and thank her for her leadership on the legislation.