Secure and Responsible Drug Disposal Act of 2010

Mr. President, I rise to thank and congratulate my colleagues for passing the Secure and Responsible Drug Disposal Act by unanimous consent. I am proud to have worked closely with Senator Klobuchar to draft and introduce the bill, and I thank her and her chief counsel, Paige Herwig, for their ideas and advocacy of commonsense drug disposal solutions.

The Secure and Responsible Drug Disposal Act will make a cost-free change to the Controlled Substances Act to permit State and private entities to accept unused controlled substances through drug take-back programs. As the Senate unanimously recognized, the Secure and Responsible Drug Disposal Act is necessary because up to 17 percent of prescribed medication goes unused every year.

State, local, and private entities already have established drug take-back programs to keep some of this unwanted medication away from children and drug abusers. But the Federal Controlled Substances Act, CSA, currently prevents these drug take-back programs from accepting the most dangerous medications--controlled substances. The CSA particularly prohibits people prescribed controlled substances from giving them to any person or entity without express permission from the Drug Enforcement Administration. As a result, individual consumers and long-term care facilities now either stockpile unwanted controlled substances or dispose of them in improper ways, such as flushing them into the water supply. This can lead to drug diversion or water pollution.

Diverted prescription drugs contributed to a 114-percent increase in overdose deaths involving prescription opioids between 2001 and 2005, and the number of treatment admissions for prescription opioids increased 74 percent from 2002 to 2006. Troublingly, over one-third of new prescription drug abusers are teenagers, who now abuse prescription drugs more than any controlled substance except marijuana.

This bill will fix the problems of unwanted prescription drug stockpiling and improper disposal by amending the CSA to allow the Attorney General to draft regulations permitting authorized entities to accept and dispose of controlled substances. These regulations will enable state, local, and private entities to operate drug take-back programs for all prescription drugs in a safe and effective manner consistent with diversion controls.

In discussing how the bill will allow drug take-back programs to accept unwanted controlled substances, I want to highlight certain provisions we added to the bill after collaborating with House colleagues and their staff. First, in authorizing new drug disposal regulations, the bill makes clear that ``the Attorney General shall take into consideration the public health and safety, as well as the ease and cost of program implementation and participation by various communities.'' Representative Jay Inslee, who has been a strong advocate for drug disposal programs, suggested this important provision. It ensures that the planned drug disposal regulations will give States and private entities wide latitude to design the most effective take-back programs for their communities. This includes considering the differences between rural and urban communities.

Second, the bill notes that the Attorney General's regulations ``may not require any entity to establish or operate a delivery or disposal program.'' Representative Joe Barton, along with other members of the House Energy and Commerce Committee, proposed this language to clarify that no State, town, or business will have to run a drug take-back program unless they want to do so. This provision is a welcomed change from the type of unfunded mandates we so often see in Federal laws.

Third, the bill allows long-term care facilities to dispose of their residents' medications, and it permits ``any person lawfully entitled to dispose of [a] decedent's property'' to deliver the decedent's unused medication for disposal. These common-sense provisions were advanced by Representatives Bart Stupak, Henry Waxman, Lamar Smith, and other House members. They address the specific concerns of long-term care facilities and the practical worries of anyone who loses a loved one.

These collected provisions, along with the bill's ``no cost'' estimate from the Congressional Budget Office, are among the many reasons the bill enjoys the support of 41 State attorneys general, the Department of Justice, and the National Association of Chain Drug Stores. They also prove that this bill is bicameral in its design, as well as bipartisan.

By passing this bill, we have taken a major step toward getting unwanted prescription drugs out of medicine cabinets and off our streets. We have given State, local, and private groups more authority to serve their communities, and we have done so in a cost-free manner.

I believe the Secure and Responsible Drug Disposal Act exemplifies the type of bipartisan legislation Congress should look to pass. I thank my colleagues again for supporting it unanimously, and I look forward to it becoming law.

I thank the gentleman for yielding, and I want to compliment the authors of the legislation in your work on this.

But I would like to point out something before we get too excited about whether we are doing a good thing today. Number one, we are--but what are we leaving on the table? If we are trying to address the issue with regard to prescription drugs and making sure that that drug gets in the hands of the right person and that the drug is safe, there is a bigger issue out there. It is called the drug safety issue and whether America's closed system is truly closed. And what we are leaving on the table is an issue which this Congress has not addressed, and it's John Dingell's drug safety bill. And not only is it that, its electronic pedigree, red paper pedigree with regard to drug safety, but the biggest one of all, I would say to the Colombian drug cartel, is that you're in the wrong drug business. We have got all the laws imaginable to whack you pretty hard for your cocaine and your marijuana. But the great threat that is occurring right now to America are drugs coming into the country that we know are not safe.

Now, let's do a quick little math because I am leaving Congress, and this is an issue that those of you who are still here, we, as a Nation, you, as legislators, must address this. We have 11 international mail facilities, 11 of them. Our ports of entry. You add UPS at Louisville and FedEx at Memphis, 13. Every day we have on average of 35,000 pharmaceutical packages coming into the international mail facilities. They are coming in because people are getting them on the Internet, and they are going to some drugsave.com out of Canada or whomever. They think it is safe, and they think that that drug is just like what I can get down at my local drugstore, and they order it. And it's coming through illicit, bad operators who are preying on America's sick and elderly.

Every time FDA goes out there and checks, we are finding that, on average, 80 percent of those drugs are either adulterated, knock-off, or they are counterfeit. Now let's do the math: 13 international mail facilities times 35,000 average per day, that gives you 455,000 of these pharmaceutical packages per day, times 365. Now we are in excess of 160 million pharmaceutical packages. We are talking boxes of drugs, not just little ones. We are talking boxes of drugs. And if 80 percent of that number are counterfeit, knock-off, adulterated drugs, we are in excess of 132 million.

Now, of a smaller percentage that the FDA actually finds and discovers, we have a return-to-sender policy. That's why I wanted to address this. Can you believe that? FDA has a return-to-sender policy. So here we are--I compliment you. We are going to say, Okay, if these drugs aren't good, we want to make sure they don't get into the hands of the people that the doctor doesn't want them to. So we are going to say, Let's destroy them. But as a Nation, our FDA has a return-to- sender policy. So when they discover in an international mail facility that the package is adulterated, knock-off, or counterfeit drugs, they don't destroy them. They do not destroy them. They then take that package and send it back to the bad actor. The bad actor must think, America, what a great place. What a great place. I will steal people's money; I will prey on the sick and the elderly; and the American Government will actually send my counterfeit drugs back to me so I can do it again.

So I just want to make this point. Your legislation is absolutely wonderful. But I want to point out, there is a really large problem out there. So before we get too excited that we are doing something really good--and we are but on a much smaller level. Because if we are going to allow millions of people to gain access to these types of drugs, we know that these drugs do not metastasize in the body in the way in which the doctors are intending them to do. And people actually think that the drugs they are taking are exactly what they can get down at

Mr. President, I thank my colleagues for their support in passing S. 3397, the Secure and Responsible Drug Disposal Act by unanimous consent this week. I thank the Senate cosponsors of this bill--Senator Grassley, Senator Brown of Ohio, Senator Gillibrand, Senator Collins, Senator Corker, Senator Feingold, Senator Kohl, Senator Schumer and Senator Durbin. I especially thank my lead cosponsor, Senator Cornyn, and his counsel Gustav Eyler for their significant efforts on behalf of this important legislation.

When the Drug Enforcement Administration brought this issue to my attention, I was eager to work on it because this is such a commonsense bill.

We know that prescription drug abuse is on the rise and what is even scarier is that it is on the rise among teenagers. In fact, teens abuse prescription drugs more than any illicit drug

besides marijuana. And according to the Partnership for a Drug-Free America, 55 percent of teens say that it is easy to get prescription drugs from their parents' medicine cabinets. We also know that up to 17 percent of all prescription drug medication goes unused each year.

This bill is an important step towards getting unused, unwanted or expired medication off families' shelves and into the hands of proper authorities. The bill makes it possible for State and local law enforcement ``take-back'' programs to accept controlled substances as well, which is something that is currently very difficult for them to do. I introduced this legislation because I believe we have to give families a better option than either leaving dangerous medication in their homes or flushing such medication into the water supply.

Parents know that keeping unwanted prescription drugs in their homes increases the risk that young people will find them, but current law provides them with few alternatives. By making it easier for people to dispose of controlled substances they no longer need, we can reduce teens' access to these drugs and help curb teen drug abuse. This bill amends the Controlled Substances Act to allow the Attorney General to draft regulations permitting authorized entities to accept and dispose of controlled substances. These regulations will enable state, local, and private entities to operate drug take-back programs for all prescription drugs, while taking the necessary steps to prevent unlawful diversion and promote safe disposal.

Senator Cornyn recounts with great specificity the provisions of this bill that were added after consultation with many of our House colleagues and their staffs. I want to mention those members whose contributions to this bill have improved it greatly: Representatives Henry Waxman, Joe Barton, Jay Inslee, Bart Stupak, and Lamar Smith. I am grateful to their offices for working with us to get this bill to a place where it could obtain the unanimous support of the U.S. Senate, and I second Senator Cornyn's comments about the specific contributions of each of those individuals and their offices.

The provisions that we added after collaboration with House offices, along with the bill's ``no cost'' estimate from the Congressional Budget Office, are among the many reasons the bill enjoys the support of 41 State attorneys general, the Department of Justice, and the National Association of Chain Drug Stores. They also prove that this bill is bicameral in its design, as well as bipartisan.

I want to thank all of my colleagues again for their support.

Madam Speaker, I move to suspend the rules and pass the Senate bill (S. 3397) to amend the Controlled Substances Act to provide for take-back disposal of controlled substances in certain instances, and for other purposes, as amended.

Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material in the Record.

Madam Speaker, I yield myself such time as I may consume.

Madam Speaker, I rise today in strong support of S. 3397, as amended, the Secure and Responsible Drug Disposal Act of 2010. This bill is our effort to respond to the very rapidly rising rate of prescription drug abuse in our country where 2,500 teens a day are using prescription drugs illegally for the first time. And this bill will help, we think, significantly in helping remove prescription drugs from the illicit drug pipeline by giving citizens an ability to get rid of their drugs, their prescription drugs, in a legal fashion so that communities can fashion a way to create drug take-back programs so citizens can get rid of their unnecessary and no longer useful prescription drugs.

The House has previously passed a version. We have made some improvements to the bill after it went through the Senate. I just want to note some of those improvements.

Today, when people do not have ready access to drug disposal programs, they often flush them down, and drugs ultimately end up in the waterways. In order to ensure that the drug take-back programs that we fashion under this bill are environmentally sound, it's important that the Attorney General consider the environmental impacts of take- back programs and work with the Environmental Protection Agency and communities on appropriate ways to dispose of the collected

substance in an environmentally sound manner. We also have provided ways to make sure communities are engaged in designing these programs so that they meet the individual needs of specific communities.

I want to thank all the people who have worked on this bipartisan legislation, particularly Representative Stupak who is ending his congressional career having done some great work in this regard.

With that, I yield as much time as he may consume to the gentleman from Michigan (Mr. Stupak).

I reserve the balance of my time.

I just want to thank Senators Klobuchar and Cornyn for their work on this and say this is a good bipartisan effort. We are not done on this, as Mr. Buyer pointed out, but this is a good start. I urge passage.

I yield back the balance of my time.

I thank the gentleman for yielding, and I rise in support of S. 3397.

Millions of Americans are prescribed narcotics for postoperative pain, bone fractures, and other ailments each year. However, most patients do not consume all the prescriptions they are prescribed. These drugs remain in drug cabinets for years, easily accessible to teens wishing to experiment with drugs.

But failure to dispose of prescription medications properly causes several problems. First, there's the potential for a child to ingest the drugs accidently. Second, we know that teen prescription drug abuse is on the rise. Unused prescriptions in a house are easily accessible to teens wishing to experiment with drugs. Third, there's a potential for narcotics to be abused by the patient or sold to someone else to abuse.

The Controlled Substance Act regulates prescription narcotics through a registration system. Currently there are roughly 1.3 million DEA registrants who are legally allowed to handle or distribute narcotics from the manufacturer to the distributor to the pharmacist to the doctor. However, the Controlled Substance Act currently exempts patients from this registration requirement. This legislation allows individuals to dispose of unused prescription controlled substances to a recipient authorized by the DEA, Drug Enforcement Administration.

The bill also authorizes the Attorney General to promulgate regulations for the lawful disposal of prescription controlled substances by a long-term care facility. S. 3397 also clarifies that the DEA regulations set forth in this legislation may not require any entity to establish a drug take-back program. It's a voluntary program.

I want to thank my friend and colleague Jay Inslee for all of his hard work on this legislation and his staff over the past years, Lamar Smith on the minority side, who worked closely with us, and colleagues on both sides of the aisle and their staff for their hard work and commitment to empower patients to prevent prescription drug abuse, especially amongst young people.

I urge my colleagues to vote in support of this legislation.