National Defense Authorization Act for Fiscal Year 2014

Floor Speech

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Ms. WARREN. Mr. President, today the Senate passed the Drug Quality and Security Act. I am proud to have worked together with Chairman Harkin, Ranking Member Alexander, and all of the Senators on the HELP Committee from both sides of the aisle over several months to develop this law, which will create commonsense oversight of the pharmaceutical compounding industry and the pharmaceutical supply chain.Ms. WARREN. Mr. President, today the Senate passed the Drug Quality and Security Act. I am proud to have worked together with Chairman Harkin, Ranking Member Alexander, and all of the Senators on the HELP Committee from both sides of the aisle over several months to develop this law, which will create commonsense oversight of the pharmaceutical compounding industry and the pharmaceutical supply chain.

Some politicians use the word ``regulation'' as if it were a curse. Certainly no one wants bad regulations or over regulation, but the impact of failing to regulate when public safety is at risk can be dangerous and even deadly.

We have an example just how deadly right in front of us--and an example of what happens when Congress fails to regulate. It starts with compounding pharmacies.

Compounding pharmacies serve individual patients who need specialized drugs. Without these customized products, some of our most vulnerable patients would not be able to get the precisely formulated medications they need. But customers have no way to evaluate the safety or purity or cleanliness of the compounded medications they receive. That is what regulations are for.

For too long, bad actors in this industry have taken advantage of lax State enforcement and confusion about Federal regulations. The consequences of too little regulation and too little enforcement were brought into sharp focus last year when a compounding pharmacy in Massachusetts, the New England Compounding Center, was identified as the source of a widespread fungal meningitis outbreak that sickened 751 people and killed 64. I wish NECC were an isolated case, but companies like it have engaged in shoddy practices for years practices that have caused sickness and injuries and even death.

There have been many attempts to fix the law and require FDA oversight in this area. In 2007 Senator Kennedy worked with Senator Roberts to develop bipartisan legislation that would have addressed this issue. If that effort had succeeded, we might have been able to spare many people great suffering. Sixty-four people from just one incident would probably be alive today. But the industry lobbyists beat back their efforts. The result? People got sick and people died.

This issue is of particular importance to Massachusetts, and I am proud to have worked with my colleagues on the HELP Committee throughout my first year in the Senate to shape earlier versions of this legislation. Throughout the bipartisan development process and the public hearings and votes in the HELP Committee, I pushed for a bill that would subject compounding pharmacies to strong FDA oversight. Those efforts, and negotiations with the House of Representatives, have produced the Drug Quality and Security Act. The bill strengthens current law and establishes tough, new regulations that will keep us all safer.

The compounding provisions of this bill are not the final word in what is needed. I believe the FDA should have more authority to inspect the records of compounding pharmacies, and we have included in the bill a GAO study that will assess the impact and effectiveness of this new law and tell us if more work is needed. But this bill is big step forward in making people safer, so I support it strongly.

This legislation has another feature that will help make drugs safer. It creates an important new oversight system to ensure we have a secure supply chain for our pharmaceutical products. Today, we can track a gallon of milk in the grocery store all the way back to its producer, but we can't verify the origins of a prescription drug on the shelves of our pharmacies. Counterfeit or illegally imported drugs can be integrated into the supply chain, and currently there is no detection mechanism. This bill ensures that we can trace a particular drug from its manufacturer all the way to the pharmacy. It will allow consumers to buy prescription medications with greater confidence that the drugs are safe, legal, and free of counterfeit or substandard ingredients. It will allow patients to have greater confidence that the pills in the bottle from the pharmacy are exactly what their doctors have ordered--nothing more and nothing less.

I commend my colleagues for stepping up to the challenge and showing that it is possible for Congress to do what is right--pass commonsense reforms that protect patients and consumers from harm. This is one of the basic functions of government: making sure that markets work by ensuring that no one cuts corners that the customer can't see or that put someone's family at risk. When all the manufacturers have to follow the same standards of cleanliness, when all of them have to account for where they got the chemicals they used in their products, the playing field is level and the customer is free to make good, independent decisions. This is how government should work--through actions to improve public health and public safety through smart, fair, and reasonable regulations that will improve the lives of all Americans. I hope that the Drug Quality and Security Act will do just that. I am proud to support it.

Some politicians use the word ``regulation'' as if it were a curse. Certainly no one wants bad regulations or over regulation, but the impact of failing to regulate when public safety is at risk can be dangerous and even deadly.

We have an example just how deadly right in front of us--and an example of what happens when Congress fails to regulate. It starts with compounding pharmacies.

Compounding pharmacies serve individual patients who need specialized drugs. Without these customized products, some of our most vulnerable patients would not be able to get the precisely formulated medications they need. But customers have no way to evaluate the safety or purity or cleanliness of the compounded medications they receive. That is what regulations are for.

For too long, bad actors in this industry have taken advantage of lax State enforcement and confusion about Federal regulations. The consequences of too little regulation and too little enforcement were brought into sharp focus last year when a compounding pharmacy in Massachusetts, the New England Compounding Center, was identified as the source of a widespread fungal meningitis outbreak that sickened 751 people and killed 64. I wish NECC were an isolated case, but companies like it have engaged in shoddy practices for years practices that have caused sickness and injuries and even death.

There have been many attempts to fix the law and require FDA oversight in this area. In 2007 Senator Kennedy worked with Senator Roberts to develop bipartisan legislation that would have addressed this issue. If that effort had succeeded, we might have been able to spare many people great suffering. Sixty-four people from just one incident would probably be alive today. But the industry lobbyists beat back their efforts. The result? People got sick and people died.

This issue is of particular importance to Massachusetts, and I am proud to have worked with my colleagues on the HELP Committee throughout my first year in the Senate to shape earlier versions of this legislation. Throughout the bipartisan development process and the public hearings and votes in the HELP Committee, I pushed for a bill that would subject compounding pharmacies to strong FDA oversight. Those efforts, and negotiations with the House of Representatives, have produced the Drug Quality and Security Act. The bill strengthens current law and establishes tough, new regulations that will keep us all safer.

The compounding provisions of this bill are not the final word in what is needed. I believe the FDA should have more authority to inspect the records of compounding pharmacies, and we have included in the bill a GAO study that will assess the impact and effectiveness of this new law and tell us if more work is needed. But this bill is big step forward in making people safer, so I support it strongly.

This legislation has another feature that will help make drugs safer. It creates an important new oversight system to ensure we have a secure supply chain for our pharmaceutical products. Today, we can track a gallon of milk in the grocery store all the way back to its producer, but we can't verify the origins of a prescription drug on the shelves of our pharmacies. Counterfeit or illegally imported drugs can be integrated into the supply chain, and currently there is no detection mechanism. This bill ensures that we can trace a particular drug from its manufacturer all the way to the pharmacy. It will allow consumers to buy prescription medications with greater confidence that the drugs are safe, legal, and free of counterfeit or substandard ingredients. It will allow patients to have greater confidence that the pills in the bottle from the pharmacy are exactly what their doctors have ordered--nothing more and nothing less.

I commend my colleagues for stepping up to the challenge and showing that it is possible for Congress to do what is right--pass commonsense reforms that protect patients and consumers from harm. This is one of the basic functions of government: making sure that markets work by ensuring that no one cuts corners that the customer can't see or that put someone's family at risk. When all the manufacturers have to follow the same standards of cleanliness, when all of them have to account for where they got the chemicals they used in their products, the playing field is level and the customer is free to make good, independent decisions. This is how government should work--through actions to improve public health and public safety through smart, fair, and reasonable regulations that will improve the lives of all Americans. I hope that the Drug Quality and Security Act will do just that. I am proud to support it.

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