Floor Statements

The gentlelady from California knows full well--she serves on the Energy and Commerce Committee--all during the markup of ObamaCare we had an alternative health plan.

I'm proud to cosponsor this bill to repeal the Affordable Care Act, ObamaCare, because the act is not affordable.

Cutting half a trillion dollars from Medicare to pay for new spending is wrong. Savings in Medicare should stay in Medicare. How severe are these cuts to Medicare? The Chief Actuary for CMS reports that 15 percent of hospitals will be unprofitable within 10 years. These cuts can endanger the viability of the hospital system and jeopardize the health care available for seniors.

Now, we have a whole alphabet soup of new agencies that are created by this monstrosity of a law. Let me tell you, the IPAD, the Independent Payment Advisory Board, we all know what that's going to do; PCORI, Patient-Centered Outcomes Research Institutes; CCIIO is the Center for Consumer Information and Insurance Oversight, they set up all the exchanges; the PCIP, which is the Pre-Existing Condition Insurance Plan. I mean, these are all new government agencies.

We need to repeal this law and start anew with commonsense solutions that encourage innovation without punishing businesses, seniors, or individuals.

Madam Chair, on rollcall No. 419, I was unavoidably detained. Had I been present, I would have voted ``no.''

Amendment Offered by Mr. Gosar

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 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.

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

I rise to offer an amendment on behalf of myself, Mr. Scalise of Louisiana, Mrs. Adams of Florida and Mr. Broun of Georgia.

My colleagues, this simple amendment will prohibit the Department of Energy from using any funds included in this bill to subordinate any loan obligation to other financing in violation of the Energy Policy Act of 2005. That was the original intent of Congress.

As chairman of the Energy and Commerce Committee's Subcommittee on Oversight and Investigation, I've led the investigation into the administration's rushed decision to loan Solyndra, a California-based solar panel manufacturing company, $535 million in taxpayers' money that was ultimately lost.

During this investigation, it was uncovered that, shockingly, the Department of Energy knew as early as August 2009 that Solyndra would go bankrupt in September of 2011, but simply proceeded to risk more taxpayers' funds throughout that time.

The investigation also discovered that following meetings with outside investors, DOE made the unprecedented decision on December 10, 2010, to subordinate $75 million of taxpayer money so more private capital could be injected into Solyndra.

Subordination gave private investors' money priority over taxpayers' money, meaning that, in the event of bankruptcy, private investors would be paid back before the taxpayers. But Secretary Chu wasn't allowed to subordinate the taxpayers' money.

As I mentioned earlier, the Energy Policy Act of 2005 states that DOE loan guarantees are not to be subordinated to other financing, and it was clear what the intent of Congress was.

In fact, DOE went out of its way to violate the will of Congress and sought the opinion of outside counsel on the legality of the subordination. And based upon this opinion, they made a decision to subordinate. And it all hinged on the word ``is,'' the meaning of the word ``is.''

In a 17-page draft memo obtained by the Energy and Commerce Committee,

DOE's private attorneys, they seem to acknowledge that the law prohibits the subordination of Department-guaranteed funds. However, this draft memo was never finalized. Instead, an email was sent by a lawyer at the law firm stating that DOE's rationale for subordination was, ``it makes the best possible case based on a reasonable interpretation supported by restructuring policy arguments.''

Now, Secretary Chu also ignored important parts of the law. The law required the Energy Secretary to notify the Attorney General in the event of a default on a loan guarantee. In a December 13, 2010 letter to Solyndra, Jonathan Silver, then-executive director of the DOE's loan program, notified Solyndra it was in default. However, Secretary Chu did not alert the Attorney General, as required by law.

In addition, Treasury and OMB officials' emails clearly indicate they believed DOE's legal justification for placing taxpayers at the back of the line was inconsistent with their interpretation of the law, and advised DOE to seek a legal opinion from the Justice Department.

In an August 17, 2011, email, Department of the Treasury Assistant Secretary for Financial Markets Mary Miller sent an email to Jeffery Zients, Deputy Director of OMB, in which she stated:

Our legal counsel believes that the statute and the DOE

regulations both require that the guaranteed loan should not

be subordinate to any loan or other debt obligation.

It is clear, Mr. Chairman, that every step of the way the Department of Energy ignored the law and did whatever it wished in order to push through the subordination.

Our investigation continues. I and my colleagues on Energy and Commerce are working on a permanent legislation solution to ensure that taxpayers are never, ever again stuck paying hundreds of millions of dollars because of the Obama administration's risky bets and decisions to put taxpayers at the back of the line. I encourage all of my colleagues to support this amendment.

How much time, Mr. Chairman, do I have left?

I yield to the gentleman from New Jersey.

I yield the balance of my time to my colleague from Florida (Mrs. Adams).

Mr. Chairman, I demand a recorded vote.

Madam Chair, on rollcall No. 313 I was unavoidably detained. Had I been present, I would have voted ``no.''

Amendment Offered by Ms. Hahn

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

Mr. Chairman, I am not going to take the full 5 minutes. My amendment is pretty simple. It will prohibit funds from being paid as bonuses to employees that are classified in the Senior Executive Service.

What we found when we looked at this, the Veterans' Affairs Committee held a hearing on this, on the budget, in February of this year. The Secretary of the VA testified that their budget request was held accountable for the program results. Of course, one of the issues that came up, Mr. Chairman, was the enormous bonuses and awards that were given out to VA employees.

I think, like many of us here in the House, we are concerned about bonuses when we have so many problems in this economy, high employment, and also we have an unmanageable backlog of cases, an extremely long wait for our veterans to see mental health professionals.

Of course, the VA has a history of poor contracting process and oversight. For example, at the Miami VA Health Center, veterans may have been exposed to HIV/AIDS due to poor sterilization procedures down there. Despite these poor records, they are giving out huge bonuses for simple things like suggestions, foreign language award, travel, savings incentives, referral bonuses.

In fact, on recruitment and relocation retention alone, almost 60,000 recipients received over 450,000 in cash bonuses. My simple amendment is saying enough is enough. What we want to do is say all of government should make a sacrifice, particularly the VA. If they're giving out these huge bonuses, why don't they cut back on their senior, senior employees.

I yield to the gentleman.

I thank the gentleman for his suggestions. I am just going to go with my amendment at this point. Having an opportunity to look this over, I think we have talked to the veterans committee, and we think it is a viable amendment. I think certainly as we move into conference, we can look at what you're suggesting, but right now I would just like to press this.

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

Let me say to the gentlelady and to Mr. Johnson and Mr. Nadler: This is a war on ethics or WOE. You talk about a war on women. This is a war on ethics. Woe to you if you vote against this bill.

Mr. Nadler was down here talking about this bill and how he's going to vote against it. But let me ask you: Is there anybody in this Chamber that wants to vote against sex-selection abortion? Is that what you want to do? The coercion of sex-selection abortion, is that what you want to do? The solicitation or acceptance of funds for sex- selection abortion, you want to vote against that? And lastly, the transportation of a woman into the country to obtain a sex-selection abortion, you want to vote against that?

Woe to you. War on ethics. This is wrong for you to do that.

In a recent letter, the Planned Parenthood has once again chosen to put profits before women's well-being and is encouraging Members of Congress to

oppose this legislation, reinforcing sex discrimination and positioning the United States of America as a safe haven for those who cannot legally acquire a sex-selection abortion in their own home countries. But this is not surprising, considering Planned Parenthood's record.

As chairman of the Energy and Commerce Committee's Subcommittee on Oversight and Investigations, I have led an investigation into Planned Parenthood's use of the more than $1 million of Federal funds they receive every day and their compliance with sexual assault and child abuse reporting laws. This was the first ever such investigation in Planned Parenthood's history.

Planned Parenthood has an extensive and well-documented record of improper Medicaid billing practices--all of you know that; you can go to the State of California and New York and read about those indictments--and violating State sexual assault and child abuse reporting laws and of encouraging young girls to simply lie about their ages to circumvent State reporting laws.

These four things in this bill, woe to you--war on ethics--if you vote against this bill. And I am just amazed that people of strong religious belief would come on this floor and say that you're going to believe that sex-selection abortion is okay. I can't even comprehend what you're doing.

So let me just close by saying I encourage all of my colleagues, both Democrats and Republicans, to support this lifesaving legislation and ban sex-selection abortions and to send a clear message that each and every girl is valued in our society.

My colleagues, with passage of this critical legislation, the United States will finally join the rest of the industrialized world in prohibiting the barbaric practice of using abortion as a method of sex selection. It is astounding that in a country that prohibits discrimination on the basis of sex in various contexts, such as employment, education, and housing, it is legal to abort a child simply because she's a girl.

Pure and simple, these abortions are female infanticide. The victims of sex-selection abortion are overwhelmingly female, and most sex- selection abortions are grisly, later-term abortions, likely occurring after the child becomes capable of feeling pain.

In a recent letter, Planned Parenthood has once again chosen to put profits before women's well-being and is encouraging Members of Congress to oppose this legislation, reinforcing sex discrimination and positioning the U.S. as a safe haven for those who cannot legally acquire a sex-selection abortion in their home countries. But this is not surprising considering Planned Parenthood's record.

A recent undercover investigation by Live Action once again exposed Planned Parenthood's hypocrisy and anti-life ideology by showing a Planned Parenthood facility located in Austin, Texas knowingly facilitating the sex-selective abortion of a baby girl. Even going so far as to coach a late term abortion, in order to confirm that the baby was the unwanted sex. The video also shows the Planned Parenthood employee instructing a young woman about how to commit Medicaid fraud.

As Chairman of the Energy and Commerce Committee's Subcommittee on Oversight and Investigations, I have led an investigation into Planned Parenthood's use of the more than $1 million federal dollars they receive everyday and their compliance with sexual assault and child abuse reporting laws. This was the first ever such investigation in Planned Parenthood's history. Planned Parenthood has an extensive and well-documented record of improper Medicaid billing practices, violating state sexual assault and child abuse reporting laws, and of encouraging young girls to lie about their ages to circumvent state reporting laws.

I encourage all of my colleagues to support this life-saving legislation and ban sex-selective abortions and to send the clear message that each and every girl is valued in our society.

Announcement by the Speaker Pro Tempore

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 thank my colleague.

Mr. Speaker, I rise in strong support of this bill. It streamlines, as mentioned, eight separate congressionally mandated reports into one, a single comprehensive report.

As chairman of the Energy and Commerce Subcommittee on Oversight and Investigation, as Mr. Scalise mentioned, I, along with Chairman Walden, have looked into the backlog and workload of the FCC. In a report we released in November, we found that annual reports to Congress, such as the Satellite Competition Report and Video Programming Report, have not been completed in years. This is just disconcerting, particularly since the Telecom Act of 1996 was designed with a deregulatory slant-- requiring the FCC to conduct these competition reports to determine whether regulation was indeed necessary. How can the FCC appropriately make these decisions and regulate an industry it has not comprehensively analyzed in more than 4 years? This bill is aimed at reducing some reporting burdens on the FCC to ensure that these annual reports are just that--they are simply reported annually.

At the same time, this bill encourages the agency in today's age of convergence to analyze competition in the marketplace as a whole, rather than based on archaic technology-specific silos. We no longer need to consider the Internet, satellite, and cable industries in a vacuum, as they compete head to head in most markets across this country.

In 1992, when we passed the Cable Act, cable occupied about 96 percent of the market. The FCC's most recent data cable now only occupies about a third of this market, competing with FIOS, satellite, Netflix, and the Internet. The report that looks at the marketplace as a whole will inform both the FCC and Congress more sufficiently, and it's a long time due. Therefore, I hope my colleagues will join me in supporting this important legislation, and I appreciate its authors.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4201) to amend the Servicemembers Civil Relief Act to provide for the protection of child custody arrangements for parents who are members of the Armed Forces.

Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days in which to revise and extend their remarks and include any extraneous material on H.R. 4201.

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

I rise today in strong support of the Servicemember Family Protection Act, H.R. 4201, a bill introduced by my good friend from Ohio (Mr. Turner).

Mr. Speaker, as our Nation's servicemembers continue to endure long deployments overseas, the Servicemembers Civil Relief Act is there to protect their interests at home. At its core, SCRA ensures that servicemembers have certain protections in the event that military service impedes their ability to meet certain financial and legal obligations.

Although the current SCRA covers everything from mortgages to cell phone contracts, it simply fails to protect one uniform framework for protecting servicemembers' rights under child custody actions by State courts. This bill would protect these rights by amending the SCRA to require that if a court gives temporary custody of a servicemember's child to someone else because of the servicemember's deployment, the servicemember has the opportunity to have the previous custody order reinstated upon their return. This would occur unless the court determines that such a move would not be in the best interest of a child. The bill would also prohibit courts from considering the absence or potential absence of a servicemember from being considered as part of the court's determination of the child's best interest. Finally, my colleagues, the bill ensures that if higher protections than that provided by the bill, H.R. 4201, exist under any State law, then the higher standard should be applied.

Mr. Speaker, in previous Congresses, Members have received anecdotal evidence of servicemembers having to make the difficult decision of choosing between their military career and the legal custody of their children because of rulings made by courts that took their military service into account when assigning custody of the child. Mr. Speaker, I believe that our servicemembers who stand guard in constant defense of our liberties should never have to make this choice. That is why this bill's revisions to SCRA are so critically important to unit morale and our Nation as a whole.

So I want to again thank Mr. Turner from Ohio for introducing this legislation. I also want to thank Chairman Jeff Miller and Ranking Member Mr. Filner for their support.

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

Mr. Speaker, I yield such time as he may consume to the gentleman from Ohio (Mr. Turner).

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

Mr. Speaker, I'll close using such time as I may consume to say:

This is a very important bill. Mr. Turner just touched on something that I think I want to bring up again. This, the language in this bill, has passed the House on seven separate occasions, six times as part of the House National Defense Authorization Act in FY 2008, 2009, 2010, 2011, 2012, and 2013, and once, my colleagues, as a stand-alone bill by voice vote in 2008. And all the while, this bill has had strong bipartisan support.

Mr. Speaker, if I can, I urge the United States Senate that, upon passage today, our colleagues over there simply take up this bill and the 10 other bills that the Veterans' Committee has passed through our committee and the House and pass those also.

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

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, I thank Chairman King for the time. I also rise today in strong support of H.R. 3670, a bill introduced by my good friend, Mr. Walz from Minnesota.

This bill extends reemployment protections to employees of the Transportation Security Administration by making them subject to the Uniformed Services Employment and Reemployment Rights Act, or USERRA.

USERRA is a law that protects the reemployment rights of servicemembers so they are able to keep their jobs, benefits, and seniority in their civilian jobs after serving on active duty.

When TSA was created soon after 9/11, it was given a USERRA exemption to allow the agency to hire new employees without delay for airport screenings. There is no evidence that applying USERRA to TSA will impede TSA's mission of protecting our Nation's air travel system. In fact, bringing TSA under USERRA will strengthen their ability to recruit and retain highly qualified veterans.

Mr. Speaker, I would note that in testimony submitted for the record on H.R. 3670, TSA stated that its current practice already conforms to the requirements that H.R. 3670 would put into statute. Therefore, enactment of H.R. 3670 would ensure existing protections could not be weakened by a change in administration rules or regulations.

I want to thank my good friend Mr. Walz for introducing this legislation. I also thank Chairman Jeff Miller of Florida and Ranking Member Filner of California for their support, and I thank Mr. King.

I thank my distinguished colleague, and let me just say to the gentleman from California, who is just getting ready to leave the floor, when he mentioned that Republicans are going to prevent tobacco prevention of our youth today, he and I both know there is a separate program in CDC just for tobacco prevention and, in fact, in this so-called PPHF, which all of us have called a slush fund, which is the prevention and public health fund, there is, right now, $191.685 million for this spending for tobacco prevention. After this bill passes, there would be $109 million still remaining in this for that smoking and health component of CDC.

I say to the gentleman from Massachusetts and Mr. Hoyer of Maryland, I mean, you're yelling fire and there's no fire. I mean, I can go through all these things to show you that your arguments are wrong. The fact that Sebelius, the head of the Health and Human Services, has said publicly--as the gentlelady from Alabama so eloquently pointed out-- she, in fact, pointed out that this so-called slush fund is not going to impact what Mr. Hoyer says, dealing with women, families, and children.

They bring up Rep. Wiliam Natcher. Well, Mr. Natcher says it's very noble, very good, and you constantly use that.

But I'm just going to take you through these different areas where you say that it's going to be unable to provide support for families and women and children.

Cancer prevention and control, which includes breast and cervical cancer screening, it's funded at $205 million in the FY 2012 budget. The FY13 budget goes up to $261 million. It goes up almost $60 million. No prevention funds are being used for free cancer screening, and they will not be affected.

Let's take birth defects and developmental disabilities. In FY 2012, the CDC birth defects program was $138 million. It's now going to be $125 million. Again, these funds would continue to receive discretionary funding. Nutrition, physical activity and obesity activities, again, will continue to receive funding, viral hepatitis screening, CDC health care statistics and surveillance, and, lastly, prevention and research center. All of these things, I say to the folks on this side, are going to continue to receive base discretionary funding.

I challenge you, the gentleman from Massachusetts, to point out where in each of the ones I have talked about, all these programs are going to remain in existence.

So how in the world can you come down to the floor and constantly say----

But the point is that you folks are not accurately portraying what this bill does, so I support H.R. 4628. I agree with Secretary Sebelius, the slush fund will not affect women, families, and children.

Mr. Speaker, last week, April 17, was Tax Day, when all hardworking Americans must file their taxes with the Internal Revenue Service. Ironically enough, April 17 was also Tax Freedom Day, the day when Americans earn just about enough earned income to pay off the tax bill for all Federal, State, and local taxes. The first 111 days of the year, everything you and I, and all Americans earn went to fund the United States Federal Government, the same government that wasted $800,000 on a GSA conference with mind readers, commemorative coins, and bike building

exercises, and the same government that thought giving half a billion dollars to Solyndra was a good idea.

In 1900, Americans paid about 5.9 percent of their income in taxes, and Tax Freedom Day came about 22 days into the year. It is a far cry, my colleagues, from what we have to endure in taxes today.

If you think 111 days to reach Tax Freedom Day is excessive, just wait till next year. We are on the cusp of a tax Armageddon. I like to call it a Taxmageddon. It's scheduled to hit on January 1, 2013. It will be the largest tax increase in memory, possibly ever, a $494 billion tax increase in 1 year.

When we talk about taxes, we usually project the increase or decrease in revenue over a 10-year budget horizon. But this $494 billion tax increase isn't over a 10-year budget window; it is an immediate massive tax increase in 1 year.

Where do these tax increases come from? There are a number of tax provisions that are set to expire at the end of this year. Unless action is taken to extend these provisions or make them permanent, it will lead to an unheard of tax increase in January.

About one-third of the tax increases will come from the expiration of the Bush tax cuts from 2001 and 2003. These tax cuts reduced the marginal rates for all Americans and expanded the child tax credit, reduced the marriage penalty, and increased the tax breaks for education costs. The majority of the tax benefits in these tax cuts were targeted towards the middle and lower income tax folks.

About a quarter of the tax increases will come from the expiration of temporary payroll tax cuts that were created just 2 years ago.

Another quarter of the tax increases will come from the expiration of the alternative minimum tax. With all of this talk about creating the Buffett rule, the President seems to forget that we already have the Buffett rule in the AMT. The AMT was created in 1969 to ensure that 155 high-income households paying zero Federal income taxes would pay income taxes. Unfortunately, it was never indexed to inflation. So more and more Americans become entangled in the AMT, and today the AMT threatens to hit most Americans in the middle class and is regularly patched to protect taxpayers, but never repealed. Unless it is dealt with, it will impact millions of middle class taxpayers.

In 2013, we get a brand new tax, courtesy of ObamaCare. There will be a 3.8 percent tax on wages and salaries over $250,000 and investment income over that same amount. While this seems like it won't affect most people, this tax can apply to unearned income, like capital gains from selling your home, which will affect middle class families when they sell property. Like the AMT tax penalty, this tax is not indexed to inflation, which means that more and more Americans will be affected by this tax over time.

We'll also see the return of the Death Tax to its pre-Bush levels, when the maximum rate can be 55 percent of your estate. I believe there should be no taxation without respiration; that is, you have to be breathing. It is wrong to tax a business or a family farm when it's transferred from parent to child. This tax has hurt family farms and family businesses where children have been forced to sell the business or farm because they could not afford to pay the Death Tax.

Federal Reserve Chairman Ben Bernanke has referred to all these expiring tax provisions as a ``massive fiscal cliff.''

When we talk about taxes, we usually project the increases over 10 years, but this is going to be immediate in the year 2013, January 1.

There has been a failure of leadership from the White House. The President's budget is full of election-year gimmicks and unwillingness to try to address the upcoming Taxmageddon. Instead, the President doubles-down on his election year rhetoric, he doesn't address expiring taxes, and instead proposes a slew of new taxes on American companies.

You do not raise taxes during a recession. Raising taxes will halt what little economic growth we had over the last 3 years and return us to the days of double-digit unemployment.

Mr. Speaker, on May 18, 2006, then-Senator Barack Obama gave a speech where he mentioned that a number of our veterans had been apparently ``shortchanged.'' He went on to say:

When a young man and woman goes off and serves the country

in the military, they should be treated with the utmost

dignity and respect when they come home.

Unfortunately, the President's budget proposal seeks to further increase the cost for health care for our military retirees and all of our veterans. On October 1, 2011, TRICARE Prime annual enrollment fees were increased dramatically for new family enrollments and dramatically for new individual enrollments. In fiscal year 2013, the administration proposes additional fees and cost-sharing increases, a new annual enrollment fee for TRICARE for Life, increases in pharmacy copayments, and a catastrophic cap of $3,000 per family.

Mr. Speaker, when our President promised our servicemembers change, I'm sure they didn't expect it would be ``shortchanged.''