Ensuring Patient Access and Effective Drug Enforcement Act of 2014

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4709) to improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and to include extraneous materials into the Record on the bill.

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

Mr. Speaker, the bill before us today is important and necessary legislation to bring greater clarity to the requirements for the safe and secure distribution and dispensing of controlled substances to combat the abuse of prescription drugs. H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by my colleagues, Representative Tom Marino of Pennsylvania, Marsha Blackburn of Tennessee, Peter Welch of Vermont, and Judy Chu of California, will facilitate greater collaboration between industry stakeholders and regulators in an effort to combat our Nation's prescription drug abuse epidemic.

Safeguarding our prescription drug supply chain is important to protect against diversion and abuse of prescription medicines. H.R. 4709 will clarify key terminology in the Controlled Substances Act to give registrants a better understanding of their responsibilities under the law.

Further, the bill will allow DEA-registered companies to submit corrective action plans to address potential violations in the absence of an imminent danger, creating a more robust and meaningful dialogue about addressing drug diversion.

That should in turn curtail unnecessary supply chain disruptions that adversely affect patient access to much-needed medications.

Additionally, the legislation requires that a report be submitted to Congress by the Secretary of HHS in consultation with the DEA and other government and industry stakeholders about how collaboration between enforcement agencies and industry can benefit patients and prevent diversion and abuse.

Equally important, H.R. 4709 will improve enforcement efforts regarding the complex and challenging problem of prescription drug diversion and abuse. It will ensure patient access to necessary medications by creating a more collaborative partnership between drug manufacturers, wholesalers, retail pharmacies, and Federal enforcement and oversight agencies such as DEA and the FDA.

After hearings last April in the Health Subcommittee of the Energy and Commerce Committee, which I chair, we heard that a more feasible and practical solution to this serious problem of drug diversion and abuse is attainable, and those provisions are included in H.R. 4709. The legislation is supported by the National Community Pharmacists Association, the National Association of Chain Drug Stores, the Healthcare Distribution Management Association, as well as the Alliance to Prevent the Abuse of Medicines, among others.

I would like to acknowledge and thank my good friend, Congressman Tom Marino, for his excellent work with this legislation. My friend from Pennsylvania is a former district attorney and former U.S. attorney. He understands the importance of law enforcement in this area. But he also understands that we will be more effective if we proceed in a collaborative, communicative, and transparent fashion. He has done excellent work here.

Mr. Speaker, by approving this legislation, we will be giving our Nation's law enforcement additional tools while protecting our patients and securing our drug supply chain in a reasonable, commonsense way.

I urge all of my colleagues to support this bill and vote for H.R. 4709.

I reserve the balance of my time.

House of Representatives,

Committee on the Judiciary,

Washington, DC, July 28, 2014.

Hon. Fred Upton,

Chairman, Committee on Energy and Commerce, Rayburn House

Office Building, Washington, DC.

Dear Chairman Upton: On June 10, 2014, the Committee on

Energy and Commerce ordered reported H.R. 4709, the

``Ensuring Patient Access and Effective Drug Enforcement Act

of 2014.'' As you know, the Committee on the Judiciary was

given an additional referral on this measure upon

introduction. As a result of your having consulted with the

Judiciary Committee concerning provisions of the bill that

fall within our Rule X jurisdiction, I agree to discharge the

Committee on the Judiciary from further consideration of H.R.

4709.

The Judiciary Committee takes this action with our mutual

understanding that, by foregoing consideration of H.R. 4709

at this time, we do not waive any jurisdiction over the

subject matter contained in this or similar legislation, and

that our committee will be appropriately consulted and

involved as the bill or similar legislation moves forward.

Our committee also reserves the right to seek appointment of

an appropriate number of conferees to any House-Senate

conference involving this or similar legislation, and

requests your support for any such request.

Finally, I would appreciate your response to this letter

confirming this understanding with respect to H.R. 4709, and

would ask that a copy of our exchange of letters on this

matter be included in the Congressional Record during

consideration of the legislation on the House floor.

Sincerely,

Bob Goodlatte,

Chairman.

Mr. Speaker, I am pleased to yield 3 minutes to the gentlewoman from Tennessee (Mrs. Blackburn), vice chairman of the Energy and Commerce Committee and another leader on this issue.

Mr. Speaker, I am pleased to yield such time as he may consume to my friend, the gentleman from Pennsylvania (Mr. Marino), the leader on this issue.

Mr. Speaker, I urge all of my colleagues to support this bipartisan legislation, and I yield back the balance of my time.

Mr. Speaker, in early 2013, a pharmacist told me about problems he was having accessing necessary prescriptions for his customers, many of whom were older cancer patients suffering with chronic pain.

What started out as a simple conversation with a constituent soon turned into serious concerns about problems in the prescription drug supply chain, problems that we aim to address here today by passing H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act.

Any legitimate business involved in distributing or dispensing prescriptions welcomes appropriate oversight and regulation. Further, we know these businesses value a collaborative working relationship with agencies like the Drug Enforcement Administration.

Manufacturers, distributors, and pharmacies alike are on the front lines every day in the fight to end the prescription drug abuse epidemic. They are making efforts to educate prescribers and patients about the safe use and disposal of prescriptions and working to implement prescription drug monitoring programs that will reduce the illegal diversion of powerful opioid pain relievers.

Despite a strong commitment to being part of the solution, distributors and pharmacists are finding that the unnecessary adversarial regulatory environment created by the DEA is putting effective enforcement outcomes in jeopardy.

As a former district attorney and United States attorney, I have fond memories of working with DEA agents to put away drug dealers. To say that I have the highest regard for the DEA and the work they do does not even begin to convey my respect for the agency and its front-line employees.

I actually went with agents and busted down drug houses. They were watching my back. I trusted them then, and I trust them now. That is why I am so passionate about this subject and why I think it is necessary to pass H.R. 4709 today.

This bill will bring much-needed clarity to critical provisions of the Controlled Substances Act. In doing so, we will ensure that the DEA's authorities are not abused and threatened by future legal challenges; foster greater collaboration, communication, and transparency between the DEA and supply chain; create more opportunities to identify bad actors at the end of the supply chain; and, most importantly, be certain that prescriptions are accessible to patients in need.

We are all in this together. We cannot enforce our way out of this epidemic. Education, treatment, and enforcement are all critical to addressing the problem, but so is collaboration.

The clarity that H.R. 4709 brings will ensure that the current regulatory culture evolves into one that rewards cooperation and brings more successful diversion control efforts in the future.

I want to thank my friend, Congresswoman Blackburn, for working closely with my team and me to develop the bill. I want to thank our champions on the other side of the aisle, Dr. Judy Chu and Representative Peter Welch, for their leadership and efforts to bring us here today.

We could not have achieved this without the efforts of Chairman Pitts and Chairman Upton and their staff on the Energy and Commerce Committee. I also must thank House Judiciary Committee Chairman Goodlatte for his forthright suggestions that made this a more effective measure worthy of consideration by this House.

Mr. Speaker, I want to thank the chairman for his work on this issue and for working with Congressmen Marino and Welch and Congresswoman Chu as we sought to move the issue forward. We also thank Chairman Upton for working with us as we brought the issue forward.

The gentleman from Vermont mentioned the epidemic and the widespread abuse that is taking place in prescription drugs and the need to do something about that. We all agree on this, and here are some stats that really back this up and show why it has become an epidemic.

In 2013, more people died in the U.S. from prescription drug abuse than from heroin and cocaine combined. Deaths involving prescription pills quadrupled between 1999 and 2010.

In 2012, the number one cause of death in 17 States was prescription drug abuse. In 2008, more than 36,000 people died from drug overdoses. Most of these death were caused by prescription drugs. That 36,000 number isn't a number to be taken lightly. It is associated with names and faces and serves as a stark reminder to every family member who has lost a loved one to an overdose.

More can and must be done to treat this growing epidemic. That is why we have all worked together on H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014. Our bill seeks to facilitate greater collaboration between industry stakeholders and regulations in our Nation's effort to combat prescription drug abuse.

There are three things that we set out to accomplish in this bill. Number one is to provide clarity to the phrase ``imminent danger to the public health or safety'' to ensure the law is crystal clear for both the DEA and legitimate businesses who want to understand what the rules of the road are, so they can do the right thing. Definitions matter and have real consequences.

Number two is require the Secretary of HHS to consult with industry players in the pharmaceutical supply chain; key regulatory agencies; Federal, State, local, and tribal law enforcement agencies; and public health experts to create a report to come to Congress within 1 year of enactment.

Number three is establish procedures for companies registered with the DEA to work together to develop corrective action that addresses concerns and clarifies key terminology in the Controlled Substances Act, so that everyone knows and has a better understanding of how to comply with the law.

This bill will not solve every problem that prescription drug abuse faces. It is one that is important that we take this meaningful step. It is a good step.

Congressman Marino, who has led on this issue, is to be commended. We have appreciated the opportunity to work with him to address what is an epidemic in so many of our communities and States.

Mr. Speaker, I thank the gentleman, and I endorse everything that the chairman just spoke about.

I am proud that the House is taking up this bipartisan action today to address an issue that impacts each of our districts, and that is prescription drug abuse.

I want to thank especially Mr. Marino, who is using his experience to bring this legislation to the floor, and it was great working with him, Mrs. Blackburn, and also with Congresswoman Chu.

Vermont is facing an opiate epidemic. That is true in many States around the country. In addition to the alarming increases in heroin abuse, we have had admissions in Vermont for prescription drug abuse that have increased 361 percent from 2005 to 2013.

As we have seen in my State, we are most effective in dealing with this public health crisis when everybody who has a stake in this works together. That is the collaborative approach that Mr. Pitts mentioned. That has got to be the providers, the public health officials, law enforcement, distributors, pharmacists. They have all got to come together to tackle this problem.

If we don't have flexibility and collaboration we can do something that might make enforcement tighter, but access to legitimate prescription drugs tougher. So the goal here is to get the balance right. We want to help folks get access to the prescription medication that they need. It alleviates suffering and it eliminates pain, but we want to make sure that the enforcement is solid so there isn't the abuse.

Today, distributors, like Burlington Drug Company in Vermont, and local pharmacies face very unpredictable enforcement from the DEA. DEA has a job, but so do the drug distributors and the doctors. That inconsistent enforcement--that unpredictable enforcement, I should say--can lead to disruptions in the supply chain, which end up limiting patient access to legitimate prescription drugs.

The Ensuring Patient Access and Effective Drug Enforcement Act will encourage collaboration between law enforcement, members of the supply chain, and public health providers and officials, while ensuring that patients have the access to the treatment their doctor has prescribed.

So this is, as you mentioned, Mr. Pitts, common sense. It is collaboration. It is working together and having mutual respect that each entity in this process has its own job to do, but for all of us to do it together, we have got to work together and communicate.

It has been great to work with Representatives Marino, Blackburn, and Chu on this bill. I thank them for their leadership. I want to also thank Chairman Upton and Ranking Member Waxman for their leadership, and, of course, Mr. Pallone and Mr. Pitts.

I urge my colleagues to support H.R. 4709.

Mr. Speaker, at this time, I yield as much time as he may consume to the gentleman from Vermont (Mr. Welch).

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

Mr. Speaker, I rise in support of H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014. This bill would help prevent prescription drug abuse, establish clear and consistent enforcement standards, and ensure patients have access to needed medications by promoting collaboration between government agencies, patients, and industry stakeholders.

It will help drug distributors and others work with the Drug Enforcement Administration to keep controlled substance prescription drugs out of the hands of drug abusers. It will also help them avoid inappropriately limiting legitimate access to these same drugs by patients who need them. Achieving that balance is a difficult challenge.

H.R. 4709 would provide definitions in the Controlled Substances Act for the phrases ``consistent with the public health and safety'' and ``imminent danger.'' It also would require the DEA to provide registrants an opportunity to submit an action plan to correct any violations of law or regulation for which DEA is considering revoking or suspending their controlled substance.

It would require FDA, in consultation with DEA, to submit a report to Congress 1 year after enactment on collaborative efforts to benefit patients and prevent diversion and abuse of controlled substances.

I want to commend Energy and Commerce members Marsha Blackburn and Peter Welch, as well as Representatives Tom Marino and Judy Chu, for their sponsorship of this bipartisan legislation. Of course, I also thank my colleagues, Chairman Upton, Chairman Pitts, Ranking Member Waxman, and all other staff who have all been instrumental in bringing H.R. 4709 to the floor today.

I urge my colleagues to join me in supporting this legislation, and I yield back the balance of my time.