Better Pain Management Through Better Data Act of 2018

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

Our work on the House floor today is the culmination of more than a year's effort to craft legislation in the Energy and Commerce Committee that will save lives and help stem the tide of the opioid crisis that has struck at the health of our people wherever they live in America.

In my Oregon district, I have held multiple roundtable discussions with parents, with those addicted, and with those who treat the addicted. I have talked with law enforcement officials and emergency room physicians. I have sought the counsel and the advice of those who are closest to this national problem, and I have worked with my colleagues to carefully craft legislation that responds to the need and to their suggestions.

The headlines--we know they are everywhere--tell the tragic stories of loved ones gone far too soon. We are confronting an addiction that mercilessly seizes control and then destroys. This killer doesn't discriminate--not by age, not by race, not by where you live, or what you believe.

We are here because opioid addiction continues to take the lives of more than 100 people in America each and every day. These are real people in all of our districts--people like Amanda.

Just this past January, Amanda was seeking relief from the pain surrounding her mental illness. She ended up dying from an overdose of fentanyl. Her father bravely shared his family's story with our committee, hoping that their loss would help spur Congress to modernize Federal laws. It is for the young people like Amanda and her parents-- people like Amanda who tragically lost their bright futures--that we come together today to advance so many bipartisan pieces of legislation.

And it is for families like hers, the ones who are left behind with the heartbreak of a loss so many of us could never comprehend, that we will not rest until we have won the fight against opioid addiction.

From passage of the Comprehensive Addiction and Recovery Act, known as CARA, and the 21st Century Cures Act last Congress under the able leadership of Chairman Fred Upton, to the $4 billion in new funding passed earlier this year by this Congress, we have worked long and hard to help families and communities in despair.

Last fall, the Health Subcommittee chairman, Mr. Burgess of Texas, invited all Members of the U.S. House to come before his Health Subcommittee and to share their best ideas on how to combat this crisis. We heard from more than 50 Members--Republicans, and Democrats alike.

This spring, the Energy and Commerce Committee held a series of legislative hearings examining ways to protect our communities, to boost our public health and prevention efforts, and to improve treatment and care for patients of all ages and all backgrounds.

While the work was not always easy, Mr. Speaker, the Energy and Commerce Committee has advanced 57 different pieces of legislation to this House floor, most with unanimous support, that may well be a record for legislating on a single issue.

So while the surge of addiction looms large before us, I believe that we as a Congress and we as the American people are up to this task. The bills before us are not our first efforts in this fight, and you have my word they will not be the last.

But I urge my colleagues today, tomorrow, the rest of this week, and next week to support the legislation before the House. We have an opportunity to save lives. We have a responsibility to our families, friends, communities, our neighbors, and our Nation to lift people out of addiction and to get America on a better path.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Virginia (Mrs. Comstock), who has been a real leader on this issue.

Mr. Speaker, I have no other speakers on this bill, so I would encourage support of H.R. 449, and I yield back the balance of my time.

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

Mr. Speaker, the opioid crisis has left no one untouched by its destruction. Every age, sex, race, and socioeconomic class has felt the weight of the opioid epidemic and the disastrous effects it has on the lives of those in our Nation.

As this epidemic continues to grow, we have seen a dramatic increase in the number of children who are suffering opioid overdoses. A study published in Pediatrics earlier this year found that the number of children admitted to hospitals from opioid overdoses has nearly doubled since 2004. Another study found that kids between 12 and 17 accounted for 60 percent of the opioid overdoses in the pediatric population.

In 2016, nearly 4,000 children and young adults between the ages of 5 and 24 years old died from overdose due to opioids, and that is why I support H.R. 449. This bipartisan legislation would require the Surgeon General to report on the public health impacts of synthetic drug use and abuse by adolescents between the ages of 12 and 18.

Surgeon General reports have produced some of the most preeminent public health data available on some of the Nation's most pressing public health crises, from the adverse health consequences of tobacco use to reports on nutrition, HIV/AIDS, and violence. This is an important bill because it will allow the Surgeon General to address the impact of synthetic drug use on the youth population, and highlight the need for increased prevention efforts in the future.

This bill, like so many of the bills we are considering today, helps raise awareness of the opioid crisis, and helps us to continue to chart a path forward in addressing this epidemic.

But, Mr. Speaker, I am concerned that collectively these 57-plus bills we will consider in total, do not go far enough in providing the resources necessary for an epidemic of this magnitude. With 115 Americans dying every day, we must ensure that people have access to treatment. The bills the House will debate this week do not do enough to expand treatment for millions suffering from this crisis.

Additionally, Mr. Speaker, I would be remiss if I did not also acknowledge that the Republicans' ongoing efforts to repeal the Affordable Care Act gut Medicaid and take away critical protections for people with preexisting conditions, and would have a devastating impact on people who suffer from opioid substance abuse.

When discussing the opioid crisis on the floor this week, I urge my colleagues to remember that protecting and expanding access to care is the most critical piece of the puzzle. And any efforts to roll back the Affordable Care Act, such as another Republican-led attempt to repeal the Affordable Care Act and gut Medicaid, will hurt those who need it most.

With that said, I am pleased to support H.R. 449 and the other bills we will consider under suspension of the rules today.

Mr. Speaker, I yield as much time as he may consume to the gentleman from New York (Mr. Jeffries), the sponsor of H.R. 449.

Mr. Speaker, I reserve the balance of my time.

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

Mr. Speaker, I thank Chairman Walden and Ranking Member Pallone for their leadership in working with us on a bipartisan basis for this important package.

We all know the stories and have heard the stories time and again from our businesses, from our schools, from families visiting us, and we know this epidemic is hitting everybody. So I appreciate the opportunity to join together with my colleagues today to address this important issue.

Mr. Speaker, I rise today in support of my bill, H.R. 5473, the Better Pain

Management Through Better Data Act, and I would like to thank Representative Ben Ray Lujan for joining me in making this a bipartisan effort as an introduction as it went through committee, and now here as we are continuing to address this on the floor.

Opioid addiction we know is plaguing our communities all across the country, creating victims, devastating families, and creating economic ruin. Long-term solutions to combating this crisis depend upon safety with existing therapies and deployment of novel next generation therapies.

We need to ensure the policy and regulatory environment allows for greater adoption and use of less addictive treatments. This legislation will facilitate better clinical data on nonopioid alternatives so that doctors have more prescribing options and fewer opioids are prescribed in the first place, lowering the risk of addiction.

The FDA is responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. While there may be alternatives to opioids for certain patients and conditions, there is a need for additional clarity and flexibility regarding what drug developers need to do to help reduce the need for opioids as part of the pain treatment regimen.

This bill directs the FDA to have public meetings and issue guidance to industry, addressing data collection and labeling for medical products that reduce pain and may replace, delay, or reduce the use of oral opioids. This is one more effort to remove the barriers to investment and unleash the full potential of biomedical expertise to address this growing crisis.

This is the primary reason, I am pleased to say, our bill has the strong support of the Biotechnology Innovation Organization, also known as BIO, which represents more than 1,000 businesses, academic institutions, State biotechnology centers, and related entities.

The experts believe this bill will stimulate renewed research and development, and more effectively prevent abuse. This is a step in the right direction and allows doctors to better meet their commitment to their most vulnerable patients by giving them both diverse and better options for nonaddictive treatments for pain.

Mr. Speaker, I thank the House today for addressing this issue, and really the ability to work together and find these solutions that we know are plaguing so many of our families. Everywhere we go we are all hearing about these stories, and I am heartened today we have joined together to provide more solutions.

Mr. Speaker, I rise in support of the Better Pain Management Through Better Data Act.

Current data collection models used by the Food and Drug Administration to measure clinical effectiveness are not ideally suited to accelerate development of opioid-sparing products. This bipartisan legislation will better allow the FDA to obtain the data they need to more quickly approve label claims for nonaddictive pain medications.

I think I have said this at least 100 times at this point, but we must work with our pharmaceutical partners and the FDA to make sure that patients across the country have nonaddictive pain management options.

I come from a blue-collar district with ironworkers and ranchers and a whole lot of jobs where wear and tear on the body is inevitable. It is simply unrealistic to think that we won't have people who need access to pain therapy. That is where nonaddictive therapies come in. This bill is another step forward in making sure that everyone has more options to treat pain.

While we are talking about nonaddictive pain medications and how important they are to break the cycle of addiction back home, I want to take a second to direct my comments toward all the pharmaceutical manufacturers who are developing or plan to develop drugs in this space: This is important. We need you to be innovative, and we need you to be aggressive.

That being said, Mr. Speaker, I am already starting to be concerned regarding the cost of these drugs. Let me put this in plain English. I am worried that the people living in different parts of America may be able to afford these drugs but families who are struggling and worrying about how to make that family budget work are going to be left out. If people can't afford these therapies and these treatments, they are not going to make a bit of difference.

We cannot create another layer of people who can afford medications and therapies and people who cannot, especially not when this issue is so important. All nonaddictive pain medications must be affordable, accessible, and of high quality.

I appreciate the hard work of the committee staff, Chairman Walden, Ranking Member Pallone, and all the stakeholders who helped get this bill to the finish line.

This epidemic is affecting too many New Mexicans, too many Americans, to not think about long-term strategies for preventing opioid use disorder in the future.

I appreciate Chairman Walden's remarks. I thank him for acknowledging that this is not the end of our work.

This committee has much work to do not just with this package, but into the future, until we are able to help everyone who is fighting addiction in America. I look forward to working with our colleagues, with the administration, and with anyone and everyone out there to make a difference when it comes to addiction in our country.

Mr. Speaker, I rise in strong support of H.R. 449, the Synthetic Drug Awareness Act of 2017, which requires the Surgeon General to report to Congress on the public health effects of the in reased use since January 2010 by individuals who are 12 to 18 years old of drugs developed and manufactured to avoid control under the Controlled Substances Act.

The term ``synthetic drug'' means a drug which is developed and manufactured to avoid control under the Controlled Substances Act.

There are more than 200 identified synthetic drug compounds and more than 90 different synthetic drug marijuana compounds.

Many of these synthetic drugs are made in foreign countries and then smuggled into the United States.

These clandestinely-made drugs have no manufacturing safety standards that are normally required by the Food and Drug Administration.

Synthetic opioids have surpassed prescription opioids as the most common drug class involved in overdose deaths in the United States.

According to the Drug Enforcement Administration, fentanyl-related deaths nationwide are up from previous years by 73 percent.

Fentanyl, a synthetic opioid created using man-made chemical components rather than naturally occurring ingredients, is 50-100 times more potent than morphine.

Overall, drug overdose deaths involving fentanyl-type drugs in th United States rose from about 3,000 in 2010 to more than 19,400 in 2016.

The rate of teen drug overdose deaths in the United States climbed 19 percent from 2014 to 2015, from 3.1 deaths per 100,000 teens to 3.7 per 100,000.

The number of American teens to die of a drug overdose leapt by almost a fifth in 2015 after seven years of decline.

The opioid epidemic claimed more than 52,000 lives in 2015.

In Texas, Synthetic opioids account for almost one-fifth of drug related overdoses.

In 2016, there were 1,375 opioid-related overdose deaths in Texas specifically, according to the National Institute on Drug Abuse.

Last year, 364 drug-related overdose deaths happened in Houston.

Synthetic marijuana, methamphetamine, cocaine, and heroin top the list of drug-related problems in the Houston area.

Geographically, death rates from overdoses involving synthetic opioids increased in 21 states, with 10 states doubling their rates from 2016-2017.

No area of the United States is exempt from this epidemic--we all know a friend, family member or loved one devastated by opioids.

H.R. 449 is a positive step in the right direction, I urge my colleagues to vote yes on H.R. 449, the Synthetic Drug Awareness Act of 2017.