Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mrs. GILLIBRAND. Mr. President, I thank Senator Lautenberg for his leadership and dedication to protecting our families. And I know why he is concerned. I know, because I think about these issues every single day.

I washed my son's hair last night in his bath. I want to make sure the chemicals in that baby shampoo are safe. I put sunblock on him this morning. I want to know that I know what the level of that protection of that sunblock actually is.

When my other son was sick last week, he had three different medications. I need to know what those medications will do for him, if they will have side effects, what the impact is.

This is exactly the question every parent asks every single day in their normal daily lives: Are the products, are the chemicals, are the things surrounding my family safe? Will they cause harm? Will they cause disease? These are real questions that we have to have answered. So I thank Senator Lautenberg for his leadership on the Safe Chemicals Act.

Yesterday hundreds of mothers gathered here in the Capitol, right in front of the Capitol building, with their kids and with advocates from all across the United States to tell Congress one simple thing: It is time to stop playing politics with the health of our families. They remind us that the effectiveness of our Nation's chemical regulations is an issue that matters to all of us, every single American and every single parent who has children.

Our families are exposed to a variety of chemicals in every aspect of their daily lives, whether it is the soap we wash our hands with, whether it is the shampoo we wash our children's hair with, whether it is the detergents we put in our clothes washer when we are doing our laundry at night, whether it is detergents we use to wash our dishes. Every day we are bombarded with chemicals, and understanding how these chemicals impact our health and the health of our families is a growing concern not just for me but for constituents all across the country.

But because of a very broken and ineffective system, our regulatory agencies are not able to provide us with enough information. The challenge our regulatory agencies face is a substantial one. Since the Toxic Control Substances Act was enacted in 1976, the EPA has faced the daunting challenge to investigate more than 84,000 chemicals in commerce, and their track record for success has been poor. Of the tens of thousands of chemicals in the marketplace, only 200 have been identified for further investigations and only 5 have been regulated.

Weekly there are news reports highlighting a new study of chemical concern found in everyday products in our homes, in our schools, and in our places of work. These reports have caused growing concern amongst consumers because we have seen links. There are studies that linked these chemicals to the rising causes of cancer, autism, learning disabilities, diabetes, asthma, obesity, developmental disorders, and infertility. These are the gravest concerns any family is ever going to face--any one of these. So we want to know if these things we were exposed to are affecting outcomes. Is there a relationship?

As a mother of young children, who are most vulnerable to chemical exposure, I am particularly concerned about what chemicals affect them, their well-being, and their development. I have one story of a young girl from Ithaca, Mira Brouwer, who died at the age of 4 because of the complications of her brain cancer treatment. Faced with the loss of her daughter, her mother Christina Brouwer founded Mira's Movement to make sure she could raise awareness about pediatric cancers and to serve as a resource for families facing their own battles with these diseases.

After an exhaustive study and review that identified potential links between chemicals and our environment and cancers such as the one young Mira had, I believe it is time for Congress to take action. We have a number of amendments today that will, again, enhance the work we are doing.

Of the two amendments I care a lot about, one is very simple. It makes sure that parents have as much information as possible when there are disclosures that accompany medicine so we know what are all the impacts there could be of that medication. I know most of my colleagues and certainly most consumers didn't realize the leaflets that come with our prescriptions are not regulated by anyone, and it is usually written by a contractor.

In 1995 the FDA recommended standards to improve the information provided to patients, but by 2008 only 75 percent of the information patients were receiving met the standards for usefulness.

I have to say I met with one mother named Kate, and her personal story about what happened to her son who was suffering from allergies and asthma. When he took a different medication, she saw him go into a depression. She didn't know there could be a relationship. That information was never provided to her. But the pain and loss she goes through every single day, remembering her son, has encouraged her to be an advocate for reform to make sure every parent has basic information that has some level of accountability so they know what the implications of all medicines can be.

The AARP and Consumer Reports have spent years trying to ensure their patients that when they receive FDA approval, standardized and up-to-date information about their medications will be provided. They support this amendment that will make that requirement.

Consumers basically have a fundamental right to know the risks associated with their prescription medications, and my amendment would give them this knowledge.

Last, and quite simply, we use sunscreen every day. In my family my kids have very fair skin. I want to know that the label on that sunscreen is accurate. I want to know if it has the protection it says it does, and this is an area that desperately needs regulation. I support the bill of Senator Reed of Rhode Island to finally give consumers the information they need with regard to sunscreen.

Thank you, Mr. President, for this opportunity. All America's families basically have a right to know if these products are safe.

I yield the floor.

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