Food and Drug Administration Safety and Innovation Act
Floor Speech
BREAK IN TRANSCRIPT
Mr. DURBIN. Mr. President, today we are considering a bill that will improve the FDA's ability to assure the safety of drugs in our medicine cabinets and medical devices in our hospitals. The FDA is an essential guardian of the public's health and safety. In the past few years, FDA has faced obstacles that call on the agency to adapt and respond to the evolving nature of reviewing, manufacturing, and distributing drugs and devices.
Some of those obstacles and challenges are addressed in the reauthorizations of the Prescription Drug User Fee Act and the Medical Device User Fee Act, which are set to expire at the end of September 2012.
Last fall, I visited Cook Medical's medical device plant in Canton, Illinois, and representatives expressed concern about the amount of time it takes medical devices to be reviewed. The FDA needs sufficient time to review medical devices, in order to ensure their safety and effectiveness. However, inefficiencies and insufficient resources can result in longer review times, which mean patients have to wait longer to benefit from new medical devices.
This bill makes key changes to maintain the safety of devices and preserve our country's leadership in biomedical innovation. The bill will authorize the FDA to collect almost $600 million in user fees over 5 years. The FDA can use these additional resources to help hire and train staff.
Furthermore, the bill makes important improvements by streamlining the review process for devices and increasing communication between the FDA and device manufacturers throughout the review process. These changes to the review of medical devices will not only help innovative device companies get their product to market faster, but will prevent patients from having to wait extra weeks and months to benefit from a new device.
In addition to reauthorizing the Prescription Drug and Medical Device User Fee Acts, this bill also establishes the Drug User Fee Act and Biosimilar User Fee Act, which gives the FAA new authority to collect user fees for generic and biosimilar drugs. Currently the FDA does not collect user fees to support the review of generic drugs, and it takes about 30 months for the agency to review generic drug applications. This extra time reduces access to safe, affordable generic drugs and leaves patients and taxpayers paying the tab for brand-name drugs that lack competition from generics.
Since the first Prescription Drug User Fee Act was enacted in 1992, the FDA began collecting user fees to support the review of applications. The FDA has cut the review time for new drugs by 60%, from 2 years to a little over 1 year. Similarly, the Generic Drug User Fee Act will give the FDA the support it needs to cut the current 30-month review time for generic drugs down to 10 months. This improvement will promote competition in the marketplace and save money by reducing the amount of time patients have to wait for less expensive generic alternatives to brand name drugs. The process of negotiating and drafting this legislation started 18 months ago and the result is a comprehensive bill that improves the safety and quality of drugs and medical devices.
Chairman Harkin and Senator Enzi have put together a bill that responds to many of these challenges, including one that is of particular interest to me----the national shortage of critical drugs. Between 2006 and 2010 the drug shortage increased 200 percent from 56 to 178 drugs. Currently the drug shortage includes over 200 drugs, like intravenous nutrition supplements, cancer treating drugs, and anesthesia.
Over the past few months, I have held three roundtable discussions at hospitals across Illinois to learn about the drug shortage and how it is affecting providers and patients. From these discussions it is clear that the drug shortage is being felt at most hospitals and those Illinois hospitals, providers, and pharmacists are working around the clock to ensure patients maintain access to drugs and safe treatments.
At Advocate Hospital in Libertyville, a doctor shared that he learned just days before starting a patient on chemotherapy that the drug was not available. Unfortunately, this is a common scenario across the country as doctors learn days before starting a treatment or even once the patient is on the hospital bed that a drug is not available. Pharmacists now spend part of each day scrambling to find drugs or an alternative treatment.
Recently I learned that a young woman on my staff here in D.C. is all too familiar with the drug shortage. She is a smart and hard-working woman who has been taking Concerta to treat her ADD since she was 14. Like most people with severe ADD, she must take her medicine at a certain time every day in order to keep her ADD symptoms from impeding basic life and work responsibilities. And while there are several ADD drugs on the market, each drug works differently and can have different side effects, so switching to a new prescription is not without risk.
Last year, the local CVS where she usually had her prescription filled started telling her they didn't have her drug in stock. She didn't think much of it as she would wake up early and walk to another CVS in the morning where she was usually able to get the prescription. Over time, she grew accustomed to going between these two CVS pharmacies to fill her prescription.
Until one month, when she carried her prescription with her for 3 days and was unable to find a pharmacy with enough Concerta to fill her 30-day prescription.
By the end of day 3, she was out of her supply. She woke up early and rode her bike to four or five CVS pharmacies until she was able to find a pharmacy that could fill her prescription. But by then it was 12 o'clock and past the prescribed time to take the drug.
The shortage of ADD drugs impacts children, adults, parents, and employees across the country.
Congress needs to take action to address the drug shortage.
The FDA Safety and Innovation Act builds on Senator Klobuchar's bill with key provisions to curb the national drug shortage. First, the bill requires drug manufacturers to notify the FDA 6 months in advance for certain drug shortages. With this much notice, the FDA can work with manufacturers to try to avoid a shortage and, when necessary, identify alternative sources of the drug to ensure we maintain a supply for patients.
This winter, thanks to open communication between the FDA and drug companies, the FDA successfully avoided a shortage of methotrexate, a vital drug to treat leukemia in children. The FDA collaborated with Illinois-based generic drug manufacturer, Hospira, to increase production of this live-saving drug when another company halted production. Requiring 6 months advance notice of a drug shortage will help the FDA to work with companies to avoid shortages of critical drugs.
Furthermore, the bill requires FDA to enhance the agency's response to shortages and will improve reporting of shortages by allowing third-parties to report drug shortages to the FDA.
This bill also takes steps to improve the safety of drugs and the drug supply chain.
In 2008, serious injuries and 81 deaths were linked to contamination of the crucial blood thinning drug heparin. The source of the contamination was a facility in China that intentionally adulterated the drug. This was a horrible illustration of what happens when adulterated and counterfeit drugs make their way into the drug supply chain and ultimately to patients. This case has also raised serious questions about the global manufacturing practices of drugs and drug ingredients and the FDA's responsibility to protect the drug supply chain.
Since the heparin incident, the global nature of the drug supply chain has only grown. Today 80 percent of active pharmaceutical ingredients are manufactured outside of the United States. This bill improves the safety of our supply chain, both domestically and internationally by requiring foreign manufacturers to register their facilities with the FDA. The bill also places greater responsibility on U.S. drug manufacturers to know their international suppliers and increases penalties for intentionally contaminating or counterfeiting drug. Counterfeit and adulterated drugs can have deadly consequences, yet the penalty for committing these crimes is less than the penalty for selling a counterfeit designer purse.
Currently, the penalty for intentionally counterfeiting or adulterating a drug is no more than 3 years in prison or a $10,000 fine or both.
This bill raises the penalty for intentionally adulterating a drug to no more than 20 years in prison or a $1 million fine or both.
And the penalty for intentionally counterfeiting drugs is raised to no more than 20 years in prison or a $4 million fine or both.
This bill addresses the drug shortage, reduces the review time for medical devices and drugs, improves the pipeline for antibiotics and pediatric drugs, and helps secure the supply chain for prescription drugs.
I would like to thank Chairman Harkin and Senator Enzi for their extraordinary leadership and hard work on this bill.
The amendment we will face this afternoon is one I am offering relative to dietary supplements. I want to make it clear what this is about.
If someone walked into their neighborhood drugstore and looked at everything on the shelf, here is what they can say: All the prescription drugs the pharmacy has access to have been reviewed by the Food and Drug Administration that they are safe and effective. All of the over-the-counter drugs have been reviewed and registered with the Food and Drug Administration to make certain they are safe and have been precleared before they can be sold. Now when they move back to the vitamin counter, all bets are off. Those are called dietary supplements. They are not subject to the same level of scrutiny, inspection, testing or regulation. It is an entirely different world.
It is understandable that there are those of us who want to be able to walk in and buy vitamins, for example, without a prescription. That is our right as Americans. But we also want to make sure that whatever is on the shelf at the pharmacy is not dangerous or at least we know it is there.
There are between 55,000 and 75,000 dietary supplements in America. We don't know the exact number. They include the obvious, vitamins and minerals, but they also go further. They include energy drinks. Ever heard of the 5-Hour Energy Drink, Monster Energy Drink? Those are not sold as colas, sodas, or beverages. They are sold as dietary supplements. Why? Because there is no regulation in terms of their contents.
We had a sad story I told on the Senate floor 2 days ago, with the family in the gallery, about a 16-year-old girl from Hagerstown, MD, who drank two Monster Energy Drinks within a 24-hour period and went into cardiac arrest. It was too much for her heart. She died. That was a dietary supplement.
My amendment says if they want to sell a dietary supplement in the United States, they have to do one basic thing: They have to go to the Food and Drug Administration and say: This is the name of my company. This is the name of my product and the ingredients in it. And here is a copy of the label. That is it.
So is it important that we know this? There will be 1,000 new products bought and sold in the United States as dietary supplements every year. Just in case we think knowing the dietary supplement facility company has been registered is enough, hang on tight. These dietary supplements are coming from all over the world. Sadly, a lot of them turn out to be dangerous.
In 2009 the FDA announced that Super Slim, a dietary supplement manufactured in China, contained the pharmaceutical ingredient sibutramine, which is no longer available in the United States and found to increase the risk of heart attack or stroke. If the manufacturers had registered this dietary supplement so we knew the ingredient, we could protect American consumers.
The same thing was true in 2001. Another Chinese-based weight-loss ingredient, aristolochic acid, was found to cause kidney damage and to be a potent carcinogen. Isn't it important for us to know this? Is it too much to ask the dietary supplement companies to go to the FDA and at least register their products before they put them on the shelves across America? Don't American families have the right to scrutiny and at least some basic knowledge of the sale of these products?
The industry is against this. They don't want to report it. They basically say: It is none of your business. We will sell what we want to sell, and that is the way it will be. If we want to volunteer the information, so be it. But we don't want to be required to disclose the information.
There are groups that see it differently. I ask unanimous consent to have printed in the Record letters that support my amendment. The Center for Science and Public Interest and the Consumers Union are in support of this amendment.
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Mr. DURBIN. I ask my colleagues when this vote comes before us, before we have another death in America from a dietary supplement from China, India, Mexico, or even in the United States, shouldn't we require the most basic information so we know the name of the company, the ingredients in the product, and what the label looks like?
The FDA has asked for this information. They asked expressly for this information. To say it is a burden on them, they already asked for it.
I ask my colleagues when this amendment comes up later this afternoon that they support this in the best interest of protecting American families and consumers.
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Mr. DURBIN. Mr. President, this is a very simple amendment. If you go into the drugstore and look at the prescription drugs, every one of them has been registered with the FDA. The over-the-counter drugs have all been registered. When you go to the dietary supplement section, there is no requirement under the law for the company selling those products to register the name of the product, the ingredients of it, or a copy of the label.
The GAO did a study in 2009, and the FDA said we need this information to protect American consumers. From what? One of them is an example on this chart. This is a Chinese product that was imported into the United States, put up for sale, and then we discovered that one of the ingredients was life-threatening. It was never registered with the FDA, and there was no disclosure of its ingredients.
If you want to sell from the counters in America, shouldn't you be required, whether you are from China, India, Mexico, or anywhere in the United States, to register your product, the ingredients in it, and a copy of the label? The FDA says they need this information to keep America safe.
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Mr. DURBIN. Mr. President, the FDA asked for this knowledge and information. What am I asking them to disclose? The name of the product, the ingredients of it, and a copy of the label. If a Chinese manufacturer wants to sell a dietary supplement in Des Moines, IA, shouldn't they have to report to the FDA the name of the product and its ingredients? It is not required by law now. Let's give the FDA this extra information to keep Americans safe.
BREAK IN TRANSCRIPT
Mr. DURBIN. Madam President, today, we are considering a bill that will improve the FDA's ability to assure the safety of drugs in our medicine cabinets and medical devices in our hospitals.
The FDA is an essential guardian of the public's health and safety.
In the past few years, FDA has faced obstacles that call on the agency to adapt and respond to the evolving nature of reviewing, manufacturing, and distributing drugs and devices.
Some of those obstacles and challenges are addressed in the reauthorizations of the Prescription Drug User Fee Act and the Medical Device User Fee Act, which are set to expire at the end of September 2012.
Last fall, I visited Cook Medical's medical device plant in Canton, IL, and representatives expressed concern about the amount of time it takes medical devices to be reviewed.
FDA needs sufficient time to review medical devices in order to ensure their safety and effectiveness. However, inefficiencies and insufficient resources can result in longer review times, which means patients have to wait longer to benefit from new medical devices.
This bill makes key changes to maintain the safety of devices and preserve our country's leadership in biomedical innovation.
The bill will authorize the FDA to collect almost $600 million in user fees over 5 years. FDA can use these additional resources to help hire and train staff.
Furthermore, the bill makes important improvements by streamlining the review process for devices and increasing communication between the FDA and device manufacturers throughout the review process.
These changes to the review of medical devices will not only help innovative device companies get their product to market faster but will prevent patients from having to wait extra weeks and months to benefit from a new device.
In addition to reauthorizing the Prescription Drug and Medical Device User Fee Acts, this bill also establishes the Generic Drug User Fee Act and Biosimilar User Fee Act, which give FDA new authority to collect user fees for generic and biosimilar drugs.
Currently the FDA does not collect user fees to support the review of generic drugs, and it takes about 30 months for the agency to review generic drug applications. This extra time reduces access to safe, affordable generic drugs and leaves patients and taxpayers paying the tab for brand-name drugs that lack competition from generics.
Since the first Prescription Drug User Fee Act was enacted in 1992, the FDA began collecting user fees to support the review of applications.
FDA has cut the review time for new drugs by 60 percent, from 2 years to a little over 1 year.
Similarly, the Generic Drug User Fee Act will give FDA the support it needs to cut the current 30-month review time for generic drugs down to 10 months.
This improvement will promote competition in the marketplace and save money by reducing the amount of time patients have to wait for less expensive generic alternatives to brand-name drugs.
The process of negotiating and drafting this legislation started 18 months ago, and the result is a comprehensive bill that improves the safety and quality of drugs and medical devices.
Chairman Harkin and Senator Enzi have put together a bill that responds to many of these challenges, including one that is of particular interest to me--the national shortage of critical drugs.
Between 2006 and 2010 the drug shortage increased 200 percent--from 56 to 178 drugs. Currently the drug shortage includes over 200 drugs, such as intravenous nutrition supplements, cancer treating drugs, and anesthesia.
Over the past few months, I have held three roundtable discussions at hospitals across Illinois to learn about the drug shortage and how it is affecting providers and patients. From these discussions it is clear that the drug shortage is being felt at most hospitals, and those Illinois hospitals, providers, and pharmacists are working around the clock to ensure patients maintain access to drugs and safe treatments.
At Advocate Hospital in Libertyville, a doctor shared that he learned just days before starting a patient on chemotherapy that the drug was not available. Unfortunately, this is a common scenario across the country as doctors learn days before starting a treatment or even once the patient is on the hospital bed that a drug is not available.
Pharmacists now spend part of each day scrambling to find drugs or an alternative treatment.
I recently learned that a young woman on my staff here in DC is all too familiar with the drug shortage. She is a smart and hardworking woman who has been taking Concerta to treat her ADD since she was 14. Like most people with severe ADD, she must take her medicine at a certain time every day in order to keep their ADD symptoms from impeding basic life and work responsibilities. And while there are several ADD drugs on the market, each drug works differently and can have different side effects, so switching to a new prescription is not without risk.
Last year, the local CVS where she usually had her prescription filled started telling her they didn't have her drug in stock. She didn't think much of it, as she would wake up early and walk to another CVS in the morning where she was usually able to get the prescription.
Over time, she grew accustomed to going between these two CVS pharmacies to fill her prescription until one month when she carried her prescription with her for 3 days and was unable to find a pharmacy with enough Concerta to fill her 30-day prescription. By the end of day 3, she was out of her supply. She woke up early and rode her bike to four or five CVS pharmacies until she was able to find a pharmacy that could fill her prescription. But by then it was 12 o'clock and past the prescribed time to take the drug.
The shortage of ADD drugs impacts children, adults, parents, and employees across the country.
Congress must take action to address the drug shortage.
The FDA Safety and Innovation Act builds on Senator Klobuchar's bill, with key provisions to curb the national drug shortage.
First, the bill requires drug manufacturers to notify the FDA 6 months in advance for certain drug shortages.
With this much notice, the FDA can work with manufacturers to try to avoid a shortage and, when necessary, identify alternative sources of the drug to ensure we maintain a supply for patients.
This winter, thanks to open communication between the FDA and drug companies, the FDA successfully avoided a shortage of methotrexate, a vital drug to treat leukemia with children.
FDA collaborated with Illinois-based generic drug manufacturer Hospira to increase production of this lifesaving drug when another company halted production.
Requiring 6 months' advance notice of a drug shortage will help the FDA to work with companies to avoid shortages of critical drugs.
Furthermore, the bill requires FDA to enhance the agency's response to shortages and will improve reporting of shortages by allowing third parties to report drug shortages to the FDA.
This bill also takes steps to improve the safety of drugs and the drug supply chain.
In 2008, serious injuries and 81 deaths were linked to contamination of the crucial blood thinning drug heparin. The source of the contamination was a facility in China that intentionally adulterated the drug. This was a horrible illustration of what happens when adulterated and counterfeit drugs make their way into the drug supply chain and ultimately to patients.
This case has also raised serious questions about the global manufacturing practices of drugs and drug ingredients and the FDA's responsibility to protect the drug supply chain. Since the heparin incident, the global nature of the drug supply chain has only grown. Today, 80 percent of active pharmaceutical ingredients are manufactured outside of the United States.
This bill improves the safety of our supply chain both domestically and internationally by requiring foreign manufacturers to register their facilities with the FDA.
The bill also places greater responsibility on U.S. drug manufacturers to know their international suppliers and increases penalties for intentionally contaminating or counterfeiting drugs.
Counterfeit and adulterated drugs can have deadly consequences, yet the penalty for committing these crimes is less than the penalty for selling a counterfeit designer purse. Currently, the penalty for intentionally counterfeiting or adulterating a drug is no more than 3 ears in prison or a $10,000 fine or both. This bill raises the penalty for intentionally adulterating a drug to no more than 20 years in prison or a $1 million fine or both. And the penalty for intentionally counterfeiting drugs is raised to no more than 20 years in prison or a $4 million fine or both.
This bill addresses the drug shortage, reduces the review time for medical devices and drugs, improves the pipeline for antibiotics and pediatric drugs, and helps secure the supply chain for prescription drugs.
I thank Chairman Harkin and Senator Enzi for their extraordinary leadership and hard work on this bill.
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