Floor Statements

Mr. Speaker, I submit an essay by a San Diego innovator, Dr. Jeff Stein, President and CEO of Trius Therapeutics. Dr. Stein provides a fascinating account of the evolution in the discovery of antibiotic treatments over the past century.

Dr. Stein's story is a vivid example as to why the private sector and public sector must work together to innovate as a means to save

lives. Dr. Stein's company is one of many across the United States working to prevent infections and improve American's quality of life.

Antibiotics Redux: Medicines That Change the Course of History

Dateline: April 1945. Hill 913, northern Italy

The 22-year old second lieutenant didn't know if it was the

machine gun, mortar round or artillery shell blast that got

him. Ordered to take out the machine gun nest hidden in a

mountaintop farmhouse all he recalled was that he was

dragging his platoon's wounded radio operator to safety when

he felt a searing pain in his upper back, then nothing. The

platoon medic took one look at the wounded lieutenant,

injected him with the maximum survivable dose of morphine,

indicating this by marking the letter ``M'' on his forehead

in his blood, then, assuming he would not survive his wounds,

left to treat other wounded platoon members. Although his

initial wounds, which included a damaged spine, an

obliterated kidney and a mangled right arm did not kill him

outright, the lieutenant was shipped home with little

expectation he'd survive. His parents were called to his

hospital bedside three separate times for a death vigil.

April 1945. Rutgers University

Four-thousand miles west of Hill 913, 25-year-old graduate

student Albert Schatz, having recently submitted his patent

application for his discovery of the antibiotic Streptomycin,

was trying to figure out how to make enough of it for human

testing. Tests in guinea pigs showed that Streptomycin was

safe and effective in the treatment of infections caused by

gram-negative bacteria and Mycobacterium tuberculosis. What

motivated Schatz was that in the first half of the century

bacterial infections--pneumonia, tuberculosis and blood

stream infections--were the top three causes of death in the

U.S. Wounded servicemen from World War II were especially

prone to infections from gram-negative bacteria and the only

other widely available antibiotic at the time, penicillin,

was largely ineffective against these pathogens. As a child

Schatz had experienced close friends dying of tuberculosis

and as a medical bacteriologist stationed in an Army hospital

in Florida during the early years of World War II, Private

Schatz sat helplessly by the bedside of dying solders whose

infections did not respond to penicillin or the experimental

antibiotics then available. He was passionate and highly

committed. Schatz produced Streptomycin from the soil

bacterium Streptomyces griseus growing in 1-liter

fermentation flasks running 24-hours a day in his basement

laboratory at Rutgers. By the end of 1945 he had produced

what he believed to be enough to treat one patient.

March 1946. Percy Jones Army Hospital, Battle Creek, Michigan

The attending doctors had virtually encased the

lieutenant's body in ice in a desperate attempt to lower his

body temperature. His weakened immune system made him

susceptible to infection and he had developed a severe lung

infection that subsequently spread to his blood with

resultant high fever. Massive doses of penicillin were

ineffective. He was dying. Word of his condition made its way

to Rutgers and Albert Schatz who subsequently rushed the

first experimental dose of Streptomycin to Percy Jones

Hospital to treat the lieutenant. The effects were nothing

short of miraculous. The lieutenant's fever broke within 24

hours and his lung infection cleared within a week. He would

survive. Later that year Streptomycin would go on to become

the world's first experimental medicine to be tested in a

double blind, placebo controlled clinical trial--the gold

standard in clinical research--where it was shown to be

effective and safe for the treatment of TB.

The lieutenant's name? Bob Dole. Yes, that Bob Dole who

would go on to become Senate Majority Leader and, in 1996,

candidate for the Presidency of the United States.

Today.

What is instructive about this true story of how an

antibiotic altered the course of history is that we are

presently on a retrograde course back to the early 20th

century with respect to the treatment of bacterial

infections. In the five-year period from 1983 to 1987 there

were 16 new antibiotics approved, whereas from 2008 to 2012

there were only two. At the same time, there is an explosive

emergence of multidrug resistant bacteria that are rendering

existing antibiotics largely ineffective. Combat veterans

returning from the Middle East have been diagnosed with drug

resistant strains of the gram-negative pathogen Acinetobacter

baumanii for which there are virtually no treatment options.

The multidrug resistant NDM-1 strain of Klebsiella

pneumoniae, which initially emerged from India, has spread

globally. One in three people in the world are infected with

a dormant version of Mycobacterium tuberculosis and a growing

number of these, reported in 60 countries, have emerged as

the highly virulent XDR-TB strain which is resistant to both

first- and second-line TB therapies and can only be treated

with a multiyear regimen of toxic drugs. Indeed, today's

situation would likely ignite the same sense of urgency in

Albert Schatz that he felt in 1945.

Fortunately, we have passionate and committed contemporary

versions of Albert Schatz working to develop new antibiotics.

Because of the enormous capital requirements and complex

regulatory pathway for antibiotics, however, these

individuals are now largely found in small biotech companies

where the truly innovative antibiotics are currently being

developed. It is unclear which, if any, of these companies

will succeed in delivering critically needed medicines to the

market. As drug resistant bacterial pathogens continue to

proliferate, regulatory headwinds and market dynamics have

made antibiotic development extremely challenging. While it

is encouraging that this disconnect is receiving growing

recognition and action amongst regulatory authorities, these

small antibiotics companies, such as Trius Therapeutics where

I am CEO, wait to see whether these regulatory incentives,

such as the GAIN Act recently passed by Congress, can be

implemented in time to make the development of new

antibiotics clinically feasible and financially tractable. It

will certainly be a race in which the outcome could alter the

course of history and yes, save lives.

Mr. Speaker, I rise to recognize the retirement of Walter F. Ekard, the Chief Administrative Officer for the County of San Diego. As the chief executive for the fifth largest county in the United States, Mr. Ekard manages a workforce of over 16,000 employees and an annual budget of $5 billion.

Mr. Ekard was appointed to this position by the five-member Board of Supervisors on May 4, 1999. He previously served as the Assistant Chief Administrative Officer and was the Boards' ``first and only choice'' for the job because of his experience and strong leadership skills.

Since he began working for the County in 1996, Mr. Ekard has been a part of its dramatic transformation, including a creation of a structurally-balance budget and the implementation of a general management system. Working closely with the Board and the County's executive team, Mr. Ekard works to institute private business management practices throughout the County, stressing customer service, fiscal accountability and teamwork. He has overseen the successful implementation of the innovative information technology outsourcing project that begun in late 1998 and is currently working to prepare San Diego County government to manage with significantly less revenue due to the State of California's budget crisis and funding cuts anticipated as a result.

Mr. Ekard brings a unique combination of qualifications and experience to this post. In fact, he served as my Chief of Staff during my time at the Board of Supervisors. He also worked as a senior policy advisor to former County Supervisor Paul Fordem (1981-1984). He also managed the Rancho Santa Fe Association from 1987 to 1996, transforming this 70-year-old organization into a smooth-running, productive and powerful regional influence. During his tenure with the Association, he worked in a capacity much like a city manager, developing linkages between the Association and other community organizations, created a long-term strategic plan to secure needed support from local and regional government agencies, and reduced administrative staff while streamlining the budget process and privatizing certain Association functions.

A native of San Diego County, Mr. Ekard received his Bachelor of Arts degree from San Diego State University and a Allis Doctor degree from the University of San Diego, School of Law. He is a member of the State Bar of California and has served on a number of community boards and commissions. He and his wife, Pam, reside in El Cajon with their family.

I.hope my colleagues will join me in recognizing the professional achievements of Mr. Walt Ekard. Without question, the community of San Diego has been made better by his contributions and are worthy of recognition by the House of Representatives today.

Mr. Chair, during today's vote on H.R. 3409, the Stop the War on Coal Act, I inadvertently voted ``no'' on Congressman Ed Markey's amendment No. 13, the first amendment voted on the bill. I would have voted ``aye'' on Mr. Markey's amendment, rollcall No. 592.

Mr. Speaker, I rise today in strong support of this piece of legislation.

All over America, Americans are having to make priority decisions in their families. The fact is this Congress needs to make some priority decisions. It is not only the right, but the responsibility, of this Congress and this Nation to make sure that our immigration policy is good for America first and foremost.

This bill will replace a failed system that actually gambled with America's future by having a lottery. It replaces it with bringing good scientists in. Let me just give you the numbers from just recently.

This is going to create 55,000 jobs. Do we want to have 6,000 Iranians coming here or do you want 6,000 scientists and researchers coming in? Do we want to set aside an area where we have over 2,000 Moroccans being given a set-aside for their country rather than treating individuals that have proven that they have an asset that we need in this country?

The real issue here is, Mr. Speaker, whether we are willing to correct a mistake of the past to move forward with a fair system that judges individuals based on their merit, not based on the country that they're coming from.

Mr. Chairman, I have an amendment at the desk.

Mr. Chairman, this is a very simple amendment. It just says you will not use Federal funds to tear down the war memorial on Mount Soledad. It is very simple. It is basically a war memorial that was originally built in honor of the veterans of Korea.

Mr. Chairman, when I was a young teenager, a young child, I still remember as my father and I drove up the coast from San Diego, he would point up at this memorial and say that is the only war memorial to Korea. At the time, I believed him. As far as I know, at that time, it was. Since then, the war memorial has been surrounded by over 3,000 plaques; many show the Star of David, many show crescents, and many show crosses. But there are those that have taken offense to the fact that this war memorial happened to be a cross, the universal sign of memorial.

All I have to say is that if we don't support this amendment not to tear down this one memorial, then I ask this body to be serious about the fact that in the United States, we have over 4 million crosses as memorials in this country. We have over 455,000 emblems that may be interpreted any way you want. We have 40,000 Stars of David as memorials on veteran property. In fact, in Normandy, England, Mexico City, and Panama, we have 130,000 crosses or other symbols that might be projected as being religious.

Sadly, what we've got going on in San Diego is those who claim, in the name of religious tolerance, to want to destroy war memorials if anyone takes offense to this. All this says is we're not going to tear down the 4 million crosses on our veterans' memorials across this country and we're not going to tear down or use any funds from this budget to tear down the war memorial that stands on top of Mount Soledad at La Jolla, San Diego, California. It's very simple and very clear.

I hope that my colleagues can say, in the spirit of tolerance, no one means to go out and be so intolerant as to tear down war memorials just because somebody may claim that it may have a religious connotation. God knows we don't want to start tearing down those 4 million crosses that exist today or those thousands of Stars of David that proudly sit today on veterans' and Federal property.

I yield to the gentleman from Florida.

I appreciate it, Mr. Chairman, and I appreciate the minority's consideration.

With that, I yield back the balance of my time.

Mr. Speaker, I rise today to congratulate Arena Pharmaceuticals and the Food and Drug Administration (FDA) on their work to approve a new weapon in the battle against obesity--Belviq. This is the first new drug for the treatment of this serous medical condition to be approved by the FDA in 13 years. According to the FDA, this innovative therapy works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.

Mr. Speaker, the health of our nation needs to be a top priority, and with over 93 million Americans impacted by obesity this type of innovation needs to be supported. The FDA's approval of Belviq is not only a step towards improving the lives of many Americans and significantly reducing healthcare costs, but it can also result in job retention and job growth in San Diego. Breakthroughs, like Belviq from the San Diego life science community, create jobs in their search for innovations to ensure a healthier future. Arena Pharmaceuticals invested over $1.5 billion dollars to get to this point, much of which was spent in California. In addition, all pivotal clinical trials were conducted here in the United States of America. By fostering cutting edge life science research, we can bring economic invigoration to San Diego and the U.S. while alleviating current medical ailments like obesity.

The life science industry employs over 2 million Americans, with the San Diego cluster being one of the largest at approximately 40,000 employees and 700 companies. Through successes in this industry with promising advancements like Belviq, more companies and research projects can emerge in the region to generate job opportunities. San Diego biotechnology is internationally renowned for important discoveries in the medical field. Belviq adds another distinction to San Diego biotechnology as our region is directly contributing to remedying obesity in the United States, which costs the nation $190 billion per year. These medical breakthroughs not only help our local businesses, but also contribute to a healthier America.

Currently, less than one third of Americans have a healthy body weight. Americans across all social and economic groups are consequently affected by medical issues caused by being overweight. This recent innovation can allow us to look towards a future in which less Americans are affected by this serious medical condition and other weight-related illnesses. As doctors have been asking for more research into new treatments for weight-loss, Belviq begins to answer these calls. Now we have taken the first steps in a new approach to obesity and will hopefully see new results.

Congratulations to Mr. Jack Lief of Arena Pharmaceuticals. The work of this innovative company will not only be felt in San Diego but across this great country.

Mr. Speaker, I stand in support of this bill.

I want to thank Chairman Upton and the leadership on both sides of the aisle for getting together and doing what's right for the American people.

In this time that we talk about economic strife, we've got to remember that the FDA can be a friend or an enemy of not only our health but also of our jobs and our economic opportunities. In California alone, Mr. Speaker, we have over 267 people working in the pharmaceutical industry.

We have over 42,000 just working in San Diego County.

This bill will not only help to protect jobs, but this bill is a bipartisan bill to save lives. What better message can we send to the American people than Washington is listening to the fact that they want bipartisan support and bipartisan efforts and bipartisan successes on things that matter?

This bill is something that matters. We're talking about preserving the economic opportunities of our fellow citizens, and we're talking about saving the lives of our family members and our neighbors.

Madam Speaker, back in the nineties, I introduced a bill dealing with the wilderness area along the border. Originally, those on the other side of the aisle in the Clinton administration opposed the inclusion of roads in that wilderness area--and they opposed it strongly--until the Secretary of the Interior came down to the border and saw the habitat destruction being caused by a lack of proper enforcement.

This situation that's being proposed now is actually to try to get this issue addressed appropriately because you have individuals who are using environmental issues as a way of blocking the enforcement of law along the border.

And let me say this to both sides of the aisle: If you really do care about the habitat destruction along the border, if you really do care about the preservation of the wildlife opportunities down there, will you ask yourself, Why are you or the Republican side not addressing the issue that the Federal Government today has not taken care of the problem at the border because it hasn't taken care of the real source of the problem of the out-of-control borders, and that is employers hiring illegals.

I challenge you: Why does the Federal Government allow businesses to deduct the price of hiring illegals? Why isn't every Democrat and Republican on the New IDEA bill cutting off the tax deduction and the ability for people to profit from the tax code by profiting from illegal immigration?

Your impact on the border will be addressed more by changing your enforcement at the workplace and your Tax Code than it will be with whatever you do at the border. So I just ask you, if you care about the environment, if you care about eliminating the scourge of illegal immigration and all the problems, why aren't you stopping the subsidy of those who are creating the problem by employing them?

Mr. Speaker, I rise today in strong support of this legislation that will repeal the job-killing, innovation-destroying tax on medical devices. I want to thank Congressman Paulsen for introducing this legislation.

Mr. Speaker, California, and particularly San Diego, is a hub of medical device activity. Companies such as NuVasive or Edwards Lifesciences Corporation are but a few of the companies that are located in my district in California, San Diego.

While considering this device tax, we've got to understand that the medical device industry in San Diego alone is a $4.9 billion job- generating, job-creating industry. This industry represents one-third of all the life sciences industries, employing in my district 10,000 employees with an average income of $100,000.

The medical device tax will cost jobs. That's not just in my district, but across the country. Hopefully we'll see this tax repealed. Because in the long run, this tax may not only cost jobs, but could cost lives.

Thank you very much. I appreciate it, Mr. Chairman.

Let's join together and pass the repeal of this destructive tax and move forward with good legislation that will provide affordable health care while providing job opportunities for our citizens.

Mr. Chairman, we've all heard the words from law enforcement: I don't make the laws; I just enforce it. The trouble is the administration is now saying: I don't like the laws. I won't enforce them in this category. It would be equivalent to an officer saying, I'm not going to enforce any drug laws because I don't agree with them. I want to wait until I may see a bank robber.

The fact is the executive branch is trying to legislate from the White House and violate the separations clause by using what is basically a pocket veto after the time limit that is described by law. That pocket veto is not only wrong; it's unconstitutional.

I would ask that the Judiciary Committee hold a hearing and ask the ICE agents about the fact that they've been directed, even when they raid a place where they have a warrant for somebody's arrest, even if they know other individuals are committing a crime at the time that they're in those situations, they're not allowed to arrest those they're witnessing in the commission of a crime under direction of the executive branch, which is trying to legislate from the White House.

We need to send a clear signal. It is for the White House and the executive branch to execute the laws of this country, not to change them, not to erase them, and not to try to legislate from a branch that is constitutionally not supposed to be making those decisions.

Mr. Speaker, I rise to recognize Ms. Snigdha Nandipati, the 2012 Scripps National Spelling Bee champion from Rancho Penasquitos, a community from my district in San Diego, California.

The winning word, guetapens, means to ambush, snare or trap. While not many people know what this word means, even less know how to spell it. Ms. Nandipati did. The eighth-grader from Francis Parker Middle School, armed with her lucky key chain, defeated 277 of the country's best spelling bee competitors in a three-day competition to win the coveted title.

As with all things, the achievement does not tell the entire story. In preparation for this competition, Ms. Nandipati studied six hours a day on a computer program created by her father, designed to generate random words for her to spell. If that was not enough, she showed initiative by founding her school's own spelling bee club so students could hone their competition skills and challenge each other.

Consider this: as this statement is typed on Microsoft Word, spell check displays its signature hashed-red line below the winning word indicating that it is either incorrectly spelled or the computer does not recognize the word; concluding that even Bill Gates, founder of Microsoft, does not recognize or know how to spell the word Ms. Nandipati prevailed with.

I hope my colleagues will join me along with many proud San Diegans in recognizing the fine achievement of Ms. Nandipati. Without question, her hard work, initiative and success are worthy of recognition by the House of Representatives.

Mr. Speaker, today I rise to honor the many outstanding achievements of Jim Brubaker, the outgoing president of the Carlsbad Hi-Noon Rotary Club. Mr. Brubaker's leadership during the 2011 2012 Rotary year has contributed significantly to the Hi-Noon Rotary Club, the community of Carlsbad and the mission of Rotary. During his tenure, the Carlsbad Hi-Noon Rotary Club sponsored; RYLA, a youth awareness leadership conference; provided a Christmas party and provided meals and gifts to needy elementary school children; co-sponsored the Oktoberfest fundraiser that benefited the Carlsbad Women's Resource Center, Carlsbad Boys and Girls Club and other charitable community organizations; sponsored a golf tournament which funded scholarships for Carlsbad high school students and Marines returning from Iraq and Afghanistan, and provided support to other needy military personnel and their families; promoted literacy by providing dictionaries for English and Spanish speaking elementary school children; conducted a Business and Ethics conference for AVID high school students; provided support to La Posada, a facility for the homeless and sponsored the Four-Way Speech Contest, a program to help develop public speaking skills of our community high school students. We assisted in the distribution of food, clothing and toys to over 400 needy Carlsbad families in conjunction with the Carlsbad Christmas Bureau. Under President Brubaker's leadership the Carlsbad Hi-Noon Rotary and its membership completed a number of other projects and provided over 9,400 volunteer hours of community service.

In the international arena, under Mr. Brubaker's leadership, a team of Carlsbad Hi-Noon Rotarians joined with others to build a house in Mexico for a needy family. Through our support of the Paul Harris Foundation, the Carlsbad Hi-Noon Rotary co-sponsored numerous other humanitarian projects all over the world including the effort to eradicate polio worldwide. We partnered with the Golden Triangle Rotary club in a program to build a school for girls in Afghanistan. Foreign exchange students were hosted as part of a program to promote better understanding of other cultures, and participated in developing a source of safe drinking water for Belize and the Ivory Coast. During Mr. Brubaker's tenure we also participated in ``Heart to Heart in Africa,'' a program to provide much needed medical help to children with heart problems in third world countries, and computers were provided for school children at the Los Tambos School in Mexico.

I hope my colleagues will join me in recognizing the many fine achievements of Jim Brubaker. Without question, his leadership and the fine work of the Carlsbad Hi-Noon Rotary Club are worthy of recognition by the House today.

Mr. Speaker, I rise today to bring to the attention of my colleagues an issue of great importance to the patient and provider community--the availability of critical diagnostic tests. On June 1, 2011, the Food and Drug Administration issued a draft guidance titled, ``Draft Guidance for Industry and FDA Staff--Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.''

As written, this draft guidance could jeopardize the future of personalized medicine and individualized treatment options for patients. I also want to note that when the FDA sought public comment on this draft guidance, the agency received correspondence from 54 organizations and individuals. Every comment received by the FDA expressed concerns about the draft guidance, and not one endorsed the approach.

For example, the Johns Hopkins University department of pathology surveyed laboratories at the university, and found that dozens of tests could be impacted by the guidance, including diagnostics for viral meningitis, and diagnosis of HIV infection in infants with infected mothers. Mayo Clinic indicated that certain important cancer diagnostics could disappear if this guidance is implemented as currently written. Public health laboratories, including those in my home state of California would lose their ability to identify and provide laboratory-based surveillance for diseases such as measles, West Nile virus, eastern equine encephalitis virus, and multidrug- resistant tuberculosis.

When the academic community expresses such serious reservations, I believe it is important that FDA review and address these concerns. It is important for the Agency to work with all stakeholders, including the patient and provider communities, on a balanced approach before issuing its final guidance.

Mr. Speaker, I rise today to recognize the United States Tennis Association, San Diego District Tennis Association, Naval Medical Center San Diego, and Balboa Tennis Club for working together to create the First Annual Military Tennis Camp for Ill, Injured and Wounded Service Members and Veterans. This remarkable event took place at Balboa Tennis Club in San Diego, May 16, 2012 through May 19, 2012, and brought over forty military heroes together to play tennis while working to improve their physical well-being and overall quality of life.

Serving our ill and wounded military service members, veterans, and their families through a variety of tennis programs is a major focus for these outstanding organizations. Tennis therapy clinics are providing exciting benefits to participants, including improved endurance, balance, hand-eye coordination and weight transfer abilities. Additionally, by enabling them to learn a new sport, these organizations are truly improving the lives of wounded service members and veterans. Tennis is an activity that service members can continue to play when they return to their hometowns and will help them reduce stress and anxiety while also improving their physical activity.

Lastly, I would like to thank the U.S. Olympic Committee, the Department of Veterans Affairs, and private donors for providing all airfare, meals, local transportation and hotel costs for each participant. Taken together, these groups raised over $40,000 to fund this great cause, and this event could not have taken place if it were not for the work and generosity of these great organizations.

I ask my colleagues to please join me in recognizing and congratulating the United States Tennis Association, the San Diego District Tennis Association, Naval Medical Center San Diego, the U.S. Olympic Committee and Balboa Tennis Club for the outstanding work they have done, and are continuing to do, for our nation's heroes and their families.

Mr. Speaker, I want to indicate my strong support of H.R. 5651, the Food and Drug Administration Reform Act of 2012, which we are addressing on the House floor today. This bipartisan legislation is not only good for the health of the American public; it is also a key component to restoring the health of our economy.

Nowhere will the impacts of this legislation be felt more than in Southern California and the San Diego region. According to BIOCOM, Southern California's life sciences cluster employs just over 97,000 in five sectors: biopharmaceuticals, industrial biotechnology and biofuels, life sciences trade, medical devices and diagnostics, and research and lab services. Medical devices and diagnostics is the region's largest life sciences sector, employing 33,871, followed by research and lab services with 31,878 jobs. These two sectors account for 68 percent of the total employment in the cluster, with over 65,000 jobs in the region. These innovative companies are on the forefront for discoveries from everything from Cancer therapies to the latest medical device that will prolong life.

The Food and Drug Administration Reform Act of 2012 will provide timely and necessary improvements to the user fee programs for drugs, medical devices, generics and biologics. Through this legislation, FDA will now be committed to meeting their performance goals for the review of life saving drugs--thus expediting these products to patients who need them, create an independent review entity to hold FDA accountable for the approval and clearance process for devices, as well as the creation of a new user fee program for generic drug and biologics approval all the while ensuring the safety of U.S. patients.

H.R. 5651 contains many provisions that will improve the lives of American patients and promote the competitiveness of the U.S. life science enterprise. However, there are two

provisions in this legislation that I am most proud of including. Included in the final House draft were two pieces of bipartisan legislation that I sponsored and worked with my colleagues on both sides of the aisle to get included. They are:

H.R. 3203, the Novel Device Regulatory Relief Act, coauthored with Representative Lois Capps (D-Santa Barbara) improves the FDA's third party review and inspection of medical devices by making the process more efficient, transparent, and beneficial to the life science industry seeking approval.

H.R. 5334, the Breakthroughs Therapy Act, coauthored with Representative Diana DeGette (D Denver) expedites the review of breakthrough drugs for patients with serious or life-threatening disease or a condition where preliminary clinical evidence shows an improvement over existing therapies.

As we move forward in reconciling our legislation with the Senate it is my hope that we can address another national crisis that was not included in the House bill--the need for a reliable track and trace system for pharmaceutical products. For years, Congress has attempted to craft legislation that would secure the distribution chain for pharmaceuticals. Either due to lack of consensus from industry and patient participants or poor timing, this was never accomplished. This lack of action has resulted in a patchwork of State laws which create opportunities for bad actors to shop for States with the lowest safety requirements in order to introduce unsafe products into the legitimate supply chain. This patchwork also creates regulatory uncertainty in the supply chain, which adds increased costs and burden to the health care system.

But this year is different. For the first time, we have seen industry stakeholders put aside differences and come to a consensus on a language that is supported by me and my friend Mr. Matheson that will create a national pedigree system which will replace a patchwork of State laws that are currently in place. While not a perfect solution, this legislation is a first step in creating a secure supply chain system that will protect the U.S. public from counterfeit drugs while preventing unwanted regulatory burden on American businesses. It is my goal to work with my colleagues to include track and trace language in the final legislation which will secure the drug supply chain and address the concerns of the large pharmaceutical distributors, secondary pharmaceutical distributors, local pharmacists, third party logistical providers and the large scale pharmacies.

In closing, I wish to thank Full Committee Chairman Fred Upton and Health Subcommittee Chairman Joe Pitts for their commitment to this issue. Without their guidance and hard work, this legislation would never have seen the light of day. I look forward to casting my vote in support of H.R. 5651 and urge my colleagues to do the same.