EXPERRT Act of 2012

Mr. Speaker, the Food and Drug Administration Reform Act, H.R. 5651, is based on user fee negotiations between FDA and the prescription drug, generic drug, biologic, and medical device industry. This reauthorization of the FDA user fees will provide stability with FDA's new product review as companies submit new and innovative devices and drugs for approval.

In codifying the User Fee Agreement, this committee has included additional provisions designed to address some of the defects of the regulatory structure and overreach by the FDA. Under my Chairmanship of the Oversight and Investigation Subcommittee, we held a hearing into FDA's regulatory efforts in the medical device space. During our hearing, many of the witnesses talked about the reluctance of FDA to approve devices and how FDA continually moved the goalposts for approval. I am glad that Title VII of this bill includes a significant number of reform provisions designed to bring certainty to the medical device field.

In addition to reforming approaches to medical devices through Title VII, the FDA's approach to rare diseases must also be modernized. I'm happy the Committee included the Faster Access to Specialized Treatments Act, FAST Act, H.R. 4132, which I introduced with my friend and colleague, Representative Ed Towns. FAST updates and modernizes Section 506 of the Food, Drug & Cosmetic Act, and updates the Accelerated Approval statute to reflect two decades worth of medical sciences that has occurred since Accelerated Approval was first created. FAST will help FDA implement broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases by using modern scientific tools.

The use of surrogate endpoints may result in fewer, smaller or shorter clinical trials without compromising FDA's existing high standards for safety or efficacy. Surrogate and clinical endpoints only need to be reasonable predictors of clinical benefit to support accelerated approval. They do not need to be validated or proven first. The changes made to current law permitting the Secretary to require validation of surrogates following accelerated approval is not intended to change FDA's long history of granting accelerated approval based on unvalidated, but predictive, surrogate endpoints.

Additionally, FAST includes explicit language for FDA to think about the challenges of rare diseases when developing their guidance and gives the rare disease community an opportunity to publically comment on FDA's draft guidance. FAST ensures that the voices of the 30 million Americans with a rare disease will be heard by FDA. There are about 7,000 rare diseases and only about 250 have any treatment. FAST will save lives, and give a voice to the voiceless; and I am glad it is in the bill.

Lastly, the committee included the Expanding and Promoting Expertise in Review of Rare Treatments, EXPERRT Act, H.R. 4156, a bill my fellow Co-Chairs of the Cystic Fibrosis Caucus and I introduced. EXPERRT will have the FDA consult with experts in rare diseases. This will ensure that FDA has access to the knowledge needed when dealing with drug approvals for diseases where FDA may lack subject matter expertise. As one of the Co-Founders of the Cystic Fibrosis Caucus, I am glad that we are giving this tool to the FDA.

I'd like to submit this letter of support for FAST signed by over 150 rare disease groups into the Record.

H.R. 5651 is a good bill that will help new drugs and new medicines get into the market and be available to patients. I support passage of the FDA Reform Act.

March 23, 2012.

Hon. Cliff Stearns,

House of Representatives, Rayburn House Office Building,

Washington, DC.

Hon. Edolphus Towns,

House of Representatives, Rayburn House Office Building,

Washington, DC.

Dear Congressmen Stearns & Towns: On behalf of patients,

physicians, and other members of the health advocacy

community we are writing to express our support for H.R.

4132, the Faster Access to Specialized Treatments (FAST) Act.

This legislation will modernize and expand the FDA's

Accelerated Approval pathway to encompass a broader range of

diseases and leverage 21st century drug development tools and

strategies. This reform will speed the approval of much-

needed therapies and cures to patients who are facing serious

and life-threatening conditions, including Alzheimer's

disease, autoimmune diseases, multiple sclerosis, Parkinson's

disease, neuromuscular disease and hundreds of rare diseases

that remain untreated.

We commend you for championing legislation that maintains

the FDA's high standard for approval while at the same time

ensuring the Agency can help facilitate the development of

new and novel therapies to patients in a more timely manner.

In many cases our patients have no available treatment for

their diseases, or they are using a therapy that is older and

may not work as effectively and safely. This is not

acceptable. We believe that this legislation will ensure

patients receive the best, modern treatment as soon as

possible and we applaud your efforts on their behalf.

Thank you for your leadership on this important bill and we

look forward to working with you as it moves forward.

Sincerely,

Abigail Alliance for Better Access to Developmental

Drugs; Advocacy for Patients with Chronic Illness,

Inc.; Affiliated American CSA Foundation; Alliance for

Aging Research; Alliance for Patient Access; American

Autoimmune Related Diseases Association; American Brain

Tumor Association; American Childhood Cancer

Organization; American College of Medical Genetics;

American Institute for Medical and Biological

Engineering; American Society of Clinical

Psychopharmacology; Batten Disease Support and Research

Association; Break Through Cancer Coalition;

Californians for Cures.

Celiac Disease Center at Columbia University; Celiac

Sprue Association; Charcot-Marie-Tooth Association

(CMTA); Children's Cardiomyopathy Foundation, Inc.;

Chinese American Association of Greater Chicago;

Coalition Duchenne; Coalition for Pulmonary Fibrosis;

Colon Cancer Alliance; Cooleys Anemia Foundation;

Crohn's and Colitis Foundation of America;

Cryoglobulinemia Vasculitis Organization; CureDuchenne;

CurePSP; Digestive Disease National Coalition; Erik

Metzler Foundation.

EveryLife Foundation for Rare Diseases; Fabry Support &

Information Group; Georgia PKU Connect; GIST Support

International; Hadley Hope Fund; Hannah's Hope Fund;

Hayden's Batten Disease Foundation Inc.; HealthHIV;

Hope4Bridget Foundation; ICE Epilepsy Alliance; I Have

IIH; In Need of Diagnosis, Inc. (INOD); Inspire;

International Cancer Advocacy Network (ICAN); Jacob's

Cure, Inc.

Jain Foundation Inc.; Jonah's Just Begun--Foundation to

Cure Sanfilippo Inc. LAM Treatment Alliance; LGS

Foundation; Liddy Shriver Sarcoma Initiative; Little

Miss Hannah Foundation; Lung Cancer Alliance; Lupus

Foundation of America; Lymphangiomatosis & Gorham's

Disease Alliance (LGDA); Lymphatic Malformation

Institute (LMI); Macular Degeneration Support, Inc.

Madisons Foundation; Midwest Asian Health Association

(MAHA); MLD Foundation; Mpdsupport.org--

Myeloproliferative Disease Support; Muscular Dystrophy

Association.

National Family Caregivers Association; National MPS

Society; National MS Society; National Niemann-Pick

Disease Foundation, Inc.; National PKU Alliance;

National Tay-Sachs & Allied Diseases Association;

National Venture Capital Association; NBIA Disorders

Association; New Jersey Association for Biomedical

Research; NKH International Family Network; Noah's

Hope--Batten Disease Fund; Oxalosis and Hyperoxaluria

Foundation; Pachyonychia Congenita Project.

Parkinson's Action Network; Parry-Romberg Syndrome

Resource, Inc.; Partnership for Cures; Polycystic

Kidney Disease Foundation; RARE Project; Russell-Silver

Syndrome Support; Scleroderma Research Foundation;

Sickle Cell Disease Association of America, Inc.;

Society for Women's Health Research; Solving Kids'

Cancer; Student Society for Stem Cell Research; Sudden

Arrhythmia Death Syndromes (SADS) Foundation; Taylor's

Tale.

The Association for Frontotemporal Degeneration (AFTD);

The Children's Medical Research Foundation, Inc.; The

Erythromelalgia Association; The Focus Foundation; The

Manton Center for Orphan Disease Research, Children's

Hospital Boston; The Reflex Sympathetic Dystrophy

Syndrome Association (RSDSA); The Stop ALD Foundation;

Tuberous Sclerosis Alliance; Veterans Health Council;

VHL Family Alliance; Vietnam Veterans of America;

ZERO--The Project to End Prostate Cancer.

My colleagues, this reauthorization of the FDA's user fees will provide stability for the FDA's new product review as companies submit new and innovative drugs, medical devices, and biologics for approval.

I am especially proud that my bill, the Faster Access to Specialized Treatments, H.R. 4132, FAST, was included in the FDA Reform Act. FAST modernizes the FDA's accelerated approval pathway to reflect scientific developments that have occurred over the past 20 years. This will allow for new drugs for people suffering from rare diseases. There are 30 million Americans suffering from one of over 7,000 rare diseases, but only 250 currently have any treatment. FAST will save lives.

I am pleased also that the bill includes the EXPERRT Act, H.R. 4156. This will help the FDA consult with medical experts when evaluating drugs designed for rare diseases, such as cystic fibrosis. As the cofounder of the Cystic Fibrosis Caucus, I am glad we are finally providing this tool to the FDA.

I obviously support the passage of this bill.

Mr. Speaker, the Food and Drug Administration Safety and Innovation Act (S. 3187) is based on user fee negotiations between FDA and the prescription drug, generic drug, biologic, and medical device industry. This reauthorization of the FDA user fees will provide stability with FDA's new product review as companies submit new and innovative devices and drugs for approval.

This bill is the result of hard work and negotiations between industry and FDA, and the hard work between Republicans and Democrats, and between the House and the Senate. This bill is a true bipartisan, bicameral bill that will serve the American people well.

In codifying the User Fee Agreement, this committee has included additional provisions designed to address some of the defects of the regulatory structure and overreach by the FDA. Under my Chairmanship of the Oversight and Investigation Subcommittee, we held a hearing into FDA's regulatory efforts in the medical device space. During our hearing, many of the witnesses talked about the reluctance of FDA to approve devices and how FDA continually moved the goalposts for approval. I am glad that Title VI of this bill includes a significant number of reform provisions designed to bring certainty to the medical device field.

In addition to reforming approaches to medical devices through Title VI, the FDA's approach to rare diseases must also be modernized.

I want to take this opportunity to thank Dr. Emil Kakkis, Julia Jenkins, Harry Sporidis, Tim Perrin, Steve Stranne, everyone at the EveryLife Foundation for Rare Diseases, Pat Furlong, Nick Manetto, everyone at the Parent Project Muscular Dystrophy, and the other 150 rare disease groups that supported FAST and ULTRA. In 2011, I met with Dr. Kakkis who introduced me to two parents who had children with rare diseases and limited options as most rare diseases do not have treatments. One parent talked about his frustration at not having any treatments, except for a drug trial happening in Europe, not the United States. We talked about how we need FDA to properly address the issue of drug approval for the rare disease community, which led to examining the Accelerated Approval pathway and trying to modernize it. We developed the Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA, H.R. 3737), which I introduced with my friend and colleague, Rep. Ed Towns, to nudge the FDA into using Accelerated Approval for rare diseases.

However, after further review of the law, FDA's history of usage of Accelerated Approval and the feedback we received from stakeholders, we realized that amending the law was not sufficient. Instead, we worked with all the stakeholders to rewrite the entirety of the Accelerated Approval statute. In March, Representative Towns and I introduced the Faster Access to Specialized Treatments Act (FAST, H.R. 4132). FAST updates and modernizes Section 506 of the Food, Drug & Cosmetic Act, and updates the Accelerated Approval statute to reflect two decades worth of medical sciences that has occurred since Accelerated Approval was first created. FAST will help FDA implement broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life- threatening diseases by using modern scientific tools.

The use of surrogate endpoints may result in fewer, smaller or shorter clinical trials without compromising FDA's existing high standards for safety or efficacy. Surrogate and clinical endpoints only need to be reasonable predictors of clinical benefit to support accelerated approval. They do not need to be validated or proven first. The changes made to current law permitting the Secretary to require validation of surrogates following accelerated approval is not intended to change FDA's long history of granting accelerated approval based on unvalidated, but predictive, surrogate endpoints.

Additionally, FAST includes explicit language for FDA to think about the challenges of rare diseases when developing their guidance and gives the rare disease community an opportunity to publically comment on FDA's draft guidance. FAST ensures that the voices of the 30 million Americans with a rare disease will be heard by FDA. There are about 7,000 rare diseases and only about 250 have any treatment. FAST will save lives, and give a voice to the voiceless; and I am glad it is in the final bill.

Lastly, the committee included the Expanding and Promoting Expertise in Review of Rare Treatments, (EXPERRT Act, H.R. 4156), a bill my fellow Co-Chairs of the Cystic Fibrosis Caucus and I introduced. EXPERRT will have the FDA consult with experts in rare diseases. This will ensure that FDA has access to the knowledge needed when dealing with drug approvals for diseases where FDA may lack subject matter expertise. As one of the Co-Founders of the Cystic Fibrosis Caucus, I am glad that we are giving this tool to the FDA. I also want to thank Stephanie Krenrich and the Cystic Fibrosis Foundation for all their hard work in developing EXPERRT.

I would like to submit these letters from the EveryLife Foundation for Rare Diseases and the Parent Project Muscular Dystrophy into the Record.

S. 3187 is a good bill that will help new drugs and new medicines get into the market and be available to patients. I support passage of the FDA Safety and Innovation Act.

Parent Project

Muscular Dystrophy,

Hackensack, NJ, June 20, 2012.

Hon. Cliff Stearns,

U.S. Congress, Washington, DC.

Rayburn House Office Building,

Dear Representative Stearns: On behalf of all patients and

families living with Duchenne muscular dystrophy--the most

common form of muscular dystrophy and the most common lethal

genetic condition diagnosed in childhood--Parent Project

Muscular Dystrophy (PPMD) would like to express its deep

gratitude for your efforts to include provisions of deep

interest to the rare disease community in S. 3187, the Food

and Drug Administration Safety and Innovation Act. The final

user fee reconciliation package between the House of

Representatives and Senate includes a number of measures that

will accelerate the Food and Drug Administration (FDA)

process of reviewing potential therapies for serious life-

threatening conditions like Duchenne, will ensure that the

patient voice has a seat at the table when key decisions are

made, and will incent industry to develop treatments for

pediatric rare diseases.

As you know, Duchenne muscular dystrophy exemplifies the

challenges faced by many patients and families afflicted by

rare diseases. It is a fatal condition with most patients not

living past their late 20s, and the only approved therapies

are steroids, which cause significant complications long-

term. With nearly 20 potential therapies in various stages of

clinical trials, our community is hopeful that better times

are ahead, and we recognize that a more efficient FDA attuned

to the needs of the rare disease patient population is

critical to our success. Again, we are most appreciative of

your efforts to ensure that the above mentioned provisions

were included in the final legislation. On behalf of Duchenne

and the broader rare disease community, thank you for your

leadership and support.

Sincerely,

Pat Furlong,

Founding President and CEO.

Mr. Speaker, the authorization of the FDA user fees will simply provide stability at FDA's new product review as companies submit new and innovative devices and drugs for their approval.

I'm especially proud that in this bill I had a piece of legislation called the Faster Access to Specialized Treatments--FAST--Act, which is H.R. 4132. It was included in the FDA Reform Act. This act modernizes the FDA accelerated approval pathways to reflect the 20 years of science developed since accelerated approval was first established in 1992. So think of that: since 1992, with this bill that I've included in our FDA bill, it will accelerate approval through the FDA. It will simply allow new drugs to get to market faster for people who are suffering from rare diseases. There are 30 million Americans suffering from one of over 7,000 rare diseases, but only 250 currently have any treatment. This act will save lives.

I would like to enter, Mr. Speaker, this letter of support for FAST signed by over 150 rare-disease groups into the Record.

I'm also glad that the FDA Reform Act includes the Expanding and Promoting Expertise in Review of Rare Treatments Act, EXPERRT Act, H.R. 4156. This will help FDA consult with medical experts when evaluating drugs dealing with rare disease such as cystic fibrosis. As the cofounder of the Cystic Fibrosis Caucus, I'm glad we're giving this tool to the FDA.

Mr. Speaker, I support passage of the FDA Reform Act.

March 23, 2012.

Hon. Cliff Stearns,

U.S. House of Representatives,

Washington, DC.

Hon. Edolphus Towns,

U.S. House of Representatives,

Washington, DC.

Dear Congressmen Stearns & Towns: On behalf of patients,

physicians, and other members of the health advocacy

community we are writing to express our support for H.R.

4132, the Faster Access to Specialized Treatments (FAST) Act.

This legislation will modernize and expand the FDA's

Accelerated Approval pathway to encompass a broader range of

diseases and leverage 21st century drug development tools and

strategies. This reform will speed the approval of much-

needed therapies and cures to patients who are facing serious

and life-threatening conditions, including Alzheimer's

disease, autoimmune diseases, multiple sclerosis, Parkinson's

disease, neuromuscular disease and hundreds of rare diseases

that remain untreated.

We commend you for championing legislation that maintains

the FDA's high standard for approval while at the same time

ensuring the Agency can help facilitate the development of

new and novel therapies to patients

in a more timely manner. In many cases our patients have no

available treatment for their diseases, or they are using a

therapy that is older and may not work as effectively and

safely. This is not acceptable. We believe that this

legislation will ensure patients receive the best, modern

treatment as soon as possible and we applaud your efforts on

their behalf.

Thank you for your leadership on this important bill and we

look forward to working with you as it moves forward.

Sincerely,

Abigail Alliance for Better Access to Developmental

Drugs; Advocacy for Patients with Chronic Illness,

Inc.; Affiliated American CSA Foundation; Alliance for

Aging Research; Alliance for Patient Access; American

Autoimmune Related Diseases Association; American Brain

Tumor Association; American Childhood Cancer

Organization; American College of Medical Genetics;

American Institute for Medical and Biological

Engineering; American Society of Clinical

Psychopharmacology; Batten Disease Support and Research

Association; Break Through Cancer Coalition;

Californians for Cures; Celiac Disease Center at

Columbia University; Celiac Sprue Association; Charcot-

Marie-Tooth Association (CMTA); Children's

Cardiomyopathy Foundation, Inc.; Chinese American

Association of Greater Chicago; Coalition Duchenne;

Coalition for Pulmonary Fibrosis; Colon Cancer

Alliance; Cooleys Anemia Foundation; Crohn's and

Colitis Foundation of America; Cryoglobulinemia

Vasculitis Organization; CureDuchenne; CurePSP;

Digestive Disease National Coalition; Erik Metzler

Foundation; EveryLife Foundation for Rare Diseases;

Fabry Support & Information Group; Georgia PKU Connect;

GIST Support International; Hadley Hope Fund; Hannah's

Hope Fund; Hayden's Batten Disease Foundation Inc.;

HealthHIV; Hope4Bridget Foundation; ICE Epilepsy

Alliance; I Have IIH; In Need of Diagnosis, Inc.

(INOD); Inspire; International Cancer Advocacy Network

(ICAN); Jacob's Cure, Inc.; Jain Foundation Inc.;

Jonah's Just Begun-Foundation to Cure Sanfilippo Inc.;

LAM Treatment Alliance; LGS Foundation; Liddy Shriver

Sarcoma Initiative; Little Miss Hannah Foundation; Lung

Cancer Alliance; Lupus Foundation of America;

Lymphangiomatosis & Gorham's Disease Alliance (LGDA);

Lymphatic Malformation Institute (LMI); Macular

Degeneration Support, Inc.; Madisons Foundation;

Midwest Asian Health Association (MAHA); MLD

Foundation; Mpdsupport.org--Myeloproliferative Disease

Support; Muscular Dystrophy Association; National

Family Caregivers Association; National MPS Society;

National MS Society; National Niemann-Pick Disease

Foundation, Inc.; National PKU Alliance; National Tay-

Sachs & Allied Diseases Association; National Venture

Capital Association; NBIA Disorders Association; New

Jersey Association for Biomedical Research; NKH

International Family Network; Noah's Hope--Batten Disease

Fund; Oxalosis and Hyperoxaluria Foundation; Pachyonychia

Congenita Project; Parkinson's Action Network; Parry-

Romberg Syndrome Resource, Inc.; Partnership for Cures;

Polycystic Kidney Disease Foundation; RARE Project;

Russell-Silver Syndrome Support; Scleroderma Research

Foundation; Sickle Cell Disease Association of America,

Inc.; Society for Women's Health Research; Solving Kids'

Cancer; Student Society for Stem Cell Research; Sudden

Arrhythmia Death Syndromes (SADS) Foundation; Taylor's

Tale; The Association for Frontotemporal Degeneration

(AFTD); The Children's Medical Research Foundation, Inc.;

The Erythromelalgia Association; The Focus Foundation; The

Manton Center for Orphan Disease Research, Children's

Hospital Boston; The Reflex Sympathetic Dystrophy Syndrome

Association (RSDSA); The Stop ALD Foundation; Tuberous

Sclerosis Alliance; Veterans Health Council; VHL Family

Alliance; Vietnam Veterans of America; ZERO--The Project

to End Prostate Cancer.

Mr. Speaker, I move to suspend the rules and pass the bill (S. 3187) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, 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 insert extraneous material in the Record.

Mr. Speaker, I yield myself 2 minutes.

Mr. Speaker, I want to thank Mr. Waxman, Chairman Harkin, Senator Enzi, and Members on both sides of the aisle in both the House and the Senate who played a role in this process. S. 3187 is a reflection of the hard work put in by both Members and staff, and of everyone's willingness to put partisanship aside to look at the issues together. Because of that outstanding dedication, we have a bill today that will make a real difference in the lives of so many patients and provide much-needed support for innovators across our great country.

At the outset of this Congress, I set a goal of enacting this bill by the end of June--and here we are, well before the clock expires for this month--in order to provide certainty for American patients and innovators. I never lost confidence that we could deliver the bipartisan reforms we needed, and I am so proud that we will accomplish that goal.

Mr. Speaker, this is a jobs bill, and it's a medical innovation bill. And as we put this package together, our goal was to improve the predictability, consistency, transparency, and efficiency of FDA regulation. These reforms will help get new treatments to patients more quickly. They will help us not only keep jobs in Michigan and all across the country, but also to create new ones. In order to get it right, we turned to patients, innovators, and job creators who provided firsthand experience of how the current system is broken. And we included many of their suggestions in the bill.

This bill includes significant accountability and reform measures designed to hold the FDA responsible for its performance. The measure includes independent assessments of FDA's drug and device review process. It also includes requiring quarterly reporting from the device center so we don't have to wait a year to find out FDA's progress. The bill is about patients, and that's why so many patient advocates have spoken out in support of these reforms. Whether it is steps that we took to support treatments for rare diseases or mitigate drug shortages or speed up the approval of devices that will improve a patient's quality of life, these are steps that will make a real and significant difference.

They're going to keep the U.S. at the forefront of medical innovation where we belong.

This bill is just the first step. This bill provides the resources and the game plans so that FDA can improve its performance.

I yield myself an additional minute.

It is now up to the FDA to execute that game plan. And I give my commitment today that our committee will continue to monitor and hold the FDA accountable for its performance. So, together, the Members of the House and the Senate have produced a bill that is a win for American patients, innovation, and job creation.

Before I conclude, I would like to recognize Warren Burke and Megan Renfrew from the Legislative Counsel's Office for their tireless work. The role of Legislative Counsel often goes unnoticed. I also want to appreciate our staff, starting with our staff director, Gary Andres, for pushing this legislation over the finish line; Clay Alspach, on the majority staff; Rachel Sher, on the minority staff; and in particular, Ryan Long, the chief counsel for the Health Subcommittee.

This bill, when it becomes law, patients will benefit from faster, newer, and better treatments, and American workers will keep us on the cutting edge of medical innovation.

I reserve the balance of my time.

Mr. Speaker, I yield 1 minute to the chairman emeritus of the Energy and Commerce Committee, the gentleman from Texas (Mr. Barton).

(Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 2 minutes to the distinguished chairman of the Health Subcommittee, the gentleman from Pennsylvania (Mr. Pitts).

Mr. Speaker, I yield 2 minutes to the gentleman from Texas (Mr. Burgess), the distinguished vice chair of the Health Subcommittee.

Mr. Speaker, I yield 1 minute to the distinguished gentleman from Florida (Mr. Stearns).

Mr. Speaker, I yield 1 minute to the distinguished gentlewoman from North Carolina, the vice chair of the Energy and Commerce Committee, Mrs. Myrick.

I yield 1 minute to the distinguished gentleman from Pennsylvania, Dr. Murphy.

Mr. Speaker, I yield 1 minute to a member of the committee, the distinguished gentleman from California (Mr. Bilbray).

Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Georgia, Dr. Gingrey, a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from New Jersey (Mr. Lance), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from Kentucky (Mr. Guthrie).

Mr. Speaker, I yield 1 minute to the gentleman from New Hampshire (Mr. Bass), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from Minnesota (Mr. Paulsen).

Mr. Speaker, may I ask how much time remains on each side?

Mr. Speaker, I have no further requests for time. So if the gentleman wants to close, then I will close.

Thank you, Mr. Speaker.

Mr. Speaker, I just want to say that with all of the positive comments here, this bill was not a piece of cake. There was a lot of hard work on both sides of the aisle, particularly by the staff on both sides of the aisle. Again, I want to cite Clay and Ryan on our staff.

But let's face it: All of us particularly involved on the health side of the issues, as we meet with different folks afflicted with different diseases, we want to find a cure. And it would be great to find that cure here in America because we have outstanding pharmaceutical industries that have the talent and the staff to work with the different departments, whether it be the NIH, the CDC, certainly the

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.