Floor Statements

Mr. Speaker, I stand to strongly support this legislation.

This bipartisan agreement represents over 18 months of work from the Energy and Commerce Health Subcommittee, and I'm especially proud and appreciative of the hard work of Ryan Long and Clay Alspach for their diligent and tireless efforts in helping to make this bill possible.

The FDA Safety and Innovation Act is critical to saving lives, improving regulatory operations, and sustaining a vital and dynamic American industry.

American companies are the leading developers of new medical devices and drugs to save and sustain life. To ensure that products are both safe and effective, we've tasked the Food and Drug Administration with reviewing products before they make their way into the market, and this is a critical responsibility.

The device and drug industries are dynamic and innovative. Companies spend hundreds of millions of dollars and years of research and work to develop products. The review stage is a critical time for any company. Inconsistent reviews mean that the true cost of developing new products is hidden, making it difficult to properly prepare.

When our Health Subcommittee began considering this legislation last year, we heard from a number of individuals about the increasing difficulty of working through the review process. American patients were waiting almost 4 years longer for new devices that had already been approved in Europe. And despite the slower U.S. review process, the safety outcomes were comparable.

The FDA Safety and Innovation Act contains important reforms to the Medical Device User Fee Act and will hold the FDA accountable and keep reviews on schedule. There are many reforms in this bill.

Finally, we include language to help patients and doctors and hospitals deal with drug shortages. Mr. Speaker, I'm

proud of the work we've done. I'm proud that we have such a bipartisan effort.

I'd like to especially thank Ranking Member Frank Pallone and his staff for patiently working with us, for Mr. Dingell, Mr. Waxman. We've accomplished much with this legislation, and it will help save lives, create jobs--two goals that we can all agree on. Thanks to our chairman, Mr. Upton.

Madam Speaker, last week, I received an extremely disturbing report about China's one-child policy from China's central Shaanxi province. Feng Jianmei was 7 months pregnant and home alone when she was abducted by government family planning officials. She was taken to a hospital and bound while her child was administered a powerful poison. After she gave birth to her dead child, without the aid of painkillers, the baby was then left beside her on the hospital bed, as shown in this picture. Her husband is a common worker, who has no recourse for the crime that has been perpetrated on his wife and child. Family planning officials in Shaanxi took this gruesome step in order to meet their quotas under China's brutal one-child policy. This is further evidence that government officials routinely take extreme measures to enforce China's barbaric one-child policy.

It's a human rights issue. It's far past time that the Chinese government stop this terrible repression and end the destruction of lives. I call on Secretary Clinton to condemn this policy in the strongest terms.

Mr. Speaker, I want to praise my colleague from Pennsylvania, Senator Toomey, for introducing an amendment to the farm bill to phase out the Federal sugar program. Though the Senate narrowly voted to table the amendment, it demonstrated that there is substantial bipartisan support to reform a program that hurts American job creators and consumers.

Today's Wall Street Journal editorial entitled ``A Tale of Two Conservatives'' also praises Senator Toomey and calls out the Republicans who voted against this free-market amendment.

By some estimates, the Federal sugar program artificially doubles the price of sugar in the United States. While we protect sugar growers and processors, sugar users and consumers are at a severe disadvantage. American jobs have been lost as foreign competitors benefit from reduced prices for raw sugar.

The Department of Commerce estimates that sugar-using industries lost 112,000 jobs from 1997 to 2009. Here in the House, I'm working with Danny Davis on a bipartisan amendment to the farm bill. I hope that when the Chamber considers reforming the farm bill, Democrats and Republicans can come together to protect jobs and stop the government from playing favorites.

Mr. Speaker, the American people have lost more than $15 billion to cronyism. Pennsylvanians alone have lost $1.4 billion.

Right now, in southern Nevada, there is an expensive hole in the ground where there should be a nuclear waste repository. We should be storing dangerous nuclear waste at a single secure and geologically sound location. Instead, much of it sits aboveground at dozens of sites scattered across the United States.

When President Obama appointed Harry Reid's aide, Gregory Jaczko, as the Nuclear Regulatory Commission chairman, he shut down Yucca Mountain against the express wishes of Congress. Jaczko even tried to stop the application process, defying a court order to continue certifying the safety of the facility.

Yesterday, this House overwhelmingly voted to give the NRC an additional $10 million to do its job. No more excuses. Do the work so that we know whether Yucca Mountain is safe.

Madam Speaker, according to the Social Security trustees, the Social Security Disability program is expected to exhaust its trust fund in just 4 years. If the fund is exhausted and if nothing is done, only around 80 percent of the benefits will be paid out. Over 11 million Americans could be impacted.

Again, we have another government entitlement program headed towards bankruptcy. This is a program that costs as much as the annual budgets of the Departments of Agriculture, Homeland Security, Commerce, Labor, Interior, and Justice combined. I know how important this program is to many of my own constituents. With regard to Medicare, Medicaid, Social Security, and the disability program, tens of millions of people rely on these programs, but they are not structurally sound.

Doing nothing is not the answer, and taking funds from the general revenue does nothing to provide the long-term stability that we need. We need real innovative reform that fixes our problems, that saves and strengthens these programs without piling up debt. If we don't act to save and strengthen these programs, our creditors will make the decisions for us down the road. We need to address these problems in a bipartisan manner. One party can't do it alone.

Mr. Speaker, in today's Wall Street Journal, Dr. Steven Greer relates his disastrous experience trying to review grants for a program created by ObamaCare.

The Center for Medicare and Medicaid Innovation will hand out more than $10 billion in the coming decade. Dr. Greer was one of the chairmen overseeing panels of outside experts who were supposed to review grants for projects to train new types of health care workers. The team had only 2 weeks to review applications that ran more than 100 pages. Among other things, work was lost to poor computer systems, leading some panelists to quit in disgust. Dr. Greer himself quit after his complaints went unanswered.

Despite the problems, the money went out the door--$1.9 million to a George Washington University project that only saves $1.7 million, $4.5 million to a San Antonio project that only saves $5 million, and $5.8 million for the University of Chicago to create 80 jobs. All this poorly supervised spending while we rack up more than $1 trillion in debt every year. More evidence that our debt problem is a spending problem.

Mr. Speaker, today, the House of Representatives will consider the Prenatal Nondiscrimination Act, a bill to ban the practice of sex-selection abortions.

If you talk to most expectant couples, you'll hear a common refrain: we don't care whether it's a boy or a girl; we just want a healthy baby. In fact, even with advanced ultrasound technology, many parents choose to wait until birth to discover the sex of their child. Unfortunately, there are exceptions. Some couples will do anything to choose the sex of their child. In the majority of these cases, boys are favored and girls are aborted.

I know most Americans think this is something that happens overseas in places like China and India. However, a Columbia University study found evidence that sex selection at the prenatal level is happening right here in the United States.

Just yesterday, the group Live Action released undercover video of a Planned Parenthood clinic in Austin, Texas, counseling a woman on how to choose the sex of her child. We shouldn't wait any longer to ban this barbaric and socially unhealthy practice. It's time to pass the bill.

Mr. Speaker, the Food and Drug Administration Reform Act of 2012 is a product of nearly a year and a half of work in the Energy and Commerce Health Subcommittee. H.R. 5651 is the result of bipartisan negotiations. The bill passed out of the Health Subcommittee by a unanimous voice vote and passed out of the full committee 46 0.

I would especially like to thank Clay Alspach, Ryan Long, and Paul Edattel and the other staffers for their dedication and hard work in making this bill possible. I know they've put in a lot of hours; and because of that work, we have brought this bill to the floor in a timely manner.

The FDA Reform Act is critical to saving lives and sustaining a dynamic American industry. American companies are the leading developers of new medical devices and drugs to save and sustain life.

To ensure that products are both safe and effective, we've tasked the Food and Drug Administration with reviewing products before they make their way into the market. This is a big job. The device and drug industries are dynamic and innovative. Companies spend tens of millions of dollars and years of work to develop products.

The review stage is a critical time for any company. Inconsistent reviews mean that the true cost of developing a new product is hidden, making it difficult to properly prepare.

When we began considering this legislation last year, we heard from a number of individuals involved in the medical device industry about the increasing difficulty of working through the review process. American patients were waiting almost 4 years longer for new devices that had already been approved in Europe, and despite the slow review process, the safety outcomes were comparable.

The FDA Reform Act contains critical reforms to the Medical Device User Fee Act which will hold the FDA accountable and keep the reviews on schedule. Under the fourth version of the Prescription Drug User Fee Act, the median time of approval was 9

months. With the reauthorization, we set the goal of reducing the review time to 8 months. Currently, generic drugs have an average approval time of 32 months. Included in this legislation is a new user- fee program that should be able to gradually reduce review times to 10 months for most products. A separate user-fee program for biosimilars has the goal of 10-month approval times for most products. Finally, we also include language to help patients, doctors, and hospitals to deal with drug shortages.

Mr. Speaker, I am proud of the work we have done here. I would like especially to thank full committee Chairman Upton as well as Health Subcommittee Ranking Member Frank Pallone, full committee Ranking Member Henry Waxman, and their staffs for patiently working with us on the FDA Reform Act.

This is legislation to help save lives and create jobs, which are two goals that we can all agree on. It is a bipartisan effort, and I urge all Members to support the legislation.

Mr. Speaker, I yield 2 minutes to a gentleman who showed great leadership in the development of this legislation, in the negotiations, and has been a very integral part, the vice-chair of the Health Subcommittee, the gentleman from Texas, Dr. Burgess.

Mr. Speaker, at this time I am happy to yield 1\1/2\ minutes to the subcommittee chairman of O&I, the gentleman from Florida (Mr. Stearns).

Mr. Speaker, I yield 2 minutes to the gentleman from Pennsylvania (Mr. Murphy), a member of the Health Subcommittee, really the author of the sections on generic drug user fees and biosimilars in the bill.

Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Gingrey), another valued member of the Health Subcommittee, the author of the GAIN Act, the section dealing with antibiotics, and a valued participant in all these negotiations.

Mr. Speaker, I yield 2 minutes to the gentleman from Ohio (Mr. LaTourette).

Mr. Speaker, in conclusion, I want to again commend leadership on both sides of the aisle: Ranking Member Emeritus Mr. Dingell and Ranking Member Mr. Pallone and Mr. Waxman and Chairman Upton and staff of both sides. They have done a terrific job and spent countless hours. I especially want to mention Clay Alspach and Ryan Long on our side, as well as our personal staff. They have been absolutely terrific. Because of this, this legislation is going to save many lives. It's going to help the United States continue to be the world leader in the pharmaceutical and medical device industries and mean a lot to our economy as well.

I urge all Members to support this very important legislation, and I yield back the balance of my time.

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

Mr. Speaker, I address the Congress today with deep concern over the Administration's lifting of sanctions against the dictatorship of Burma.

We are working to get support, assistance and even proposing the transfer of weapons to the opposition in Syria, but yet, in Burma--a place where there are at least 500,000 displaced people in one area and some report over 70,000 new displaced people due to attacks against the Kachin perpetrated by the actions of dictators--this Administration is rewarding the regime and their brutality.

Why do our policies give value to the lives of the opposition in Syria while denying the value of the lives of ethnic minorities and democratic activists in Burma?

The Administration's actions expose a shameful approach--one that allows U.S. businesses to invest in a land still drenched in bloodshed and where some prosper through the oppression of others. We should not be lifting any sanctions against dictators in Burma until they prove over time that they will stick to their word and they actually end their attacks against the people of Burma.

It is absurd to be lifting sanctions while a well-known brutal dictatorship continues to attack, displace, and even kill the people within its country.

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

The reconciliation package we bring to the floor today sensibly reduces spending so that we can continue to adequately defend our Nation.

The first responsibility of the Federal Government is to keep our Nation safe from foreign threats. By cutting wasteful spending and reforming programs, we can continue to maintain a military that keeps us secure at home and makes the world a more peaceful place.

I am proud to report that the Energy and Commerce Committee exceeded the budget instructions by $17 billion to save a total of $114 billion over 10 years. In three titles, we cut wasteful programs created by ObamaCare, reform the Medicaid program, and reform our broken medical liability system.

With the Nation struggling with trillion-dollar deficits, the President chose to increase government spending by more than another $1 trillion with his health care law. This wasn't reform; it was a government takeover of one-sixth of the U.S. economy that will increase dependency and bankrupt the Nation. We continue to push for full repeal, but also do everything we can to stop wasteful and unwise spending immediately.

The Prevention and Public Health Fund is a classic example of how government bureaucrats fail to spend public funds wisely. The health care law provided an advance appropriation of $16 billion and called for a permanent annual allotment of $2 billion per year for this fund. That's $2 billion a year in perpetuity. So, in 2036, 2037, and 2057, the Secretary of HHS has complete authority over this $2 billion to spend on whatever he or she wishes without coming back for appropriations authorization from Congress. Let's call this what it is: It's a slush fund for the Secretary of Health and Human Services.

Almost any program can make a claim that it is preventative. The Secretary has the sole role of control of the fund and, so far, has found some quite interesting ways to spend it. For example:

In Pitt County, North Carolina, a recipient used the money to fund signage for parks and bike lanes;

In Boston, they spent $1 million on urban gardening;

One of the vaunted successes of the program was getting the city of Baldwin Park, California, to put a 9-month moratorium on construction of fast food restaurants. Government should be encouraging job creation, not finding ways to stop it for a few months;

New York spent $3 million to lobby for a soda tax issue;

Philadelphia spent money to push for higher State cigarette excise taxes. Why on Earth is the Federal Government paying for campaigns to lobby State governments?

These are all examples from just the last 2 years. Who knows what projects will get money in the future.

We have numerous public health and prevention funds that can be managed through the yearly appropriations process. A permanent slush fund with

limited oversight guarantees that money will be wasted every year.

We also repealed the unlimited authority to fund the implementation of State health insurance exchanges. ObamaCare gave the Secretary a credit card with no limit, a bottomless direct appropriation. This is unprecedented and unwise. Again, we need oversight in order to make sure that the public's money is being wisely spent. Congress never should have abdicated its authority in this area, and now we need to reclaim it.

We defund the CO-OP program before billions of public dollars can be lost. The Office of Management and Budget estimates that a significant portion of the funds given to unproven CO-OPs would never be returned to the Treasury. We would stop this funding before HHS creates its own Solyndra.

The President's health care law places a dramatically increased burden on State Medicaid programs. The maintenance of effort provisions restrict States from making commonsense reforms to stop fraud and abuse. We know that Medicaid is rife with fraudulent claims. In 2011, there were $15 billion in improper payments. We need to give States the flexibility to run these programs efficiently and to help the truly needy.

We also repeal an unwise bonus program that encourages States to undermine the integrity of the program. We should not place unnecessary barriers to qualifying for Medicaid, but neither should we encourage States to oversimplify reviews of eligibility. We do not have unlimited funds. Again, Medicaid coverage needs to be open only to the truly needy.

Finally, we include real medical liability reform in this reconciliation package. The President's health care law gave a pitiful $50 million for liability reform demonstration projects.

This is paying lip service to a $200 billion problem.

I recently heard from a doctor who has been practicing in my district for decades. He bemoaned defensive medicine but was even more concerned that doctors being trained in today's climate don't even realize that they are prescribing unnecessary tests.

Defensive medicine is simply becoming the norm. Medical liability reform means saving for consumers, for doctors, and for the government.

Mr. Speaker, I am proud of the job we've done in the Energy and Commerce Committee.

I urge all of my colleagues to support the reconciliation package.

I would now yield such time as he may consume to the gentleman from Florida (Mr. Diaz-Balart).

Mr. Speaker, I very much appreciate the gentleman's concerns and want to assure him that these issues deserve the attention of my Health Subcommittee. And as we continue the legislative process, I will gladly work with the gentleman and Governor Fortuno to address the needs of our most vulnerable citizens in the territories.

Mr. Speaker, yesterday, the Energy and Commerce Health Subcommittee approved bipartisan legislation to reauthorize and reform the Food and Drug Administration user-fee program. This bill will smooth the process of reviewing medical devices and drugs, increasing transparency and predictability. It's a big step in the right direction for helping American companies continue to lead the world in medical research. Unfortunately, the medical device industry faces a huge setback starting next year.

Last week, Senator Toomey and I visited Precision Medical Products in Denver, Pennsylvania. In a roundtable meeting, we heard from a dozen medical device companies about how the new ObamaCare medical device tax will destroy jobs and stall research. This new 2.3 percent tax is on all revenue--and not just profits--meaning even if a company is struggling to break even or even losing money, they have to pay this hefty tax bill. This new tax is over and above the new user fees that they have agreed to pay.

Already, some companies have cut back. Yesterday, we took a big step forward. But if this new tax becomes reality next year, we could still lose the edge on medical device equipment. It should be repealed.

Mr. Speaker, pursuant to clause 1, rule I, I demand a vote on agreeing to the Speaker's approval of the Journal.

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

Mr. Speaker, on the back of today's Wall Street Journal, which I have in my hands, is featured a shocking story about pills coming from China containing human flesh. South Korean authorities intercepted tens of thousands of capsules and confirmed that they were composed of ground up pieces of aborted fetuses and were marketed as ``stamina boosters.''

This horror again reiterates why we should be concerned with pharmaceuticals coming from mainland China. These human flesh capsules are both abhorrent and a threat to health, possibly containing superbacteria. It is revolting to discover that there are individuals in China who will attempt to pass off such an abomination as medicine.

The Journal goes on to note that it was just last month that regulators cracked down on pills from China containing high amounts of chromium, a known carcinogen. Today's grim news reminds us to be vigilant in protecting the safety of our drug supply chain and to carefully monitor health products coming from China. These pills are a terrible affront to human dignity and a serious danger to health.

Mr. Speaker, last week, liberal MSNBC host Ed Schultz found himself agreeing with the Heritage Foundation and Mitt Romney. What issue could possibly unite liberals and conservatives? The answer is: sugar reform.

You see, sugar farmers and sugar processors benefit from a Federal sugar program that fixes prices and guarantees their profits. Indeed, Schultz noted that one of the biggest processors, American Crystal Sugar, makes $1.5 billion in revenue and pays its CEO $2.4 million a year in compensation.

While Schultz is, probably, mostly concerned about a labor dispute between American Crystal and its workers, I hope he will also consider the many other workers in sugar-using industries. The Federal program inflates the price of sugar in the U.S., placing American sugar users at a severe disadvantage to their foreign competition. In the last 15 years, more than 100,000 workers in sugar-using industries have lost their jobs.

I've been proud to work with Congressman Danny Davis to reform this program and to make it fair for everyone. Democrats and Republicans, liberals and conservatives agree that the government shouldn't be guaranteeing corporate profits at the expense of workers and consumers. I hope the Ag Committee will reform the sugar program as we deal with the farm bill.

Mr. Speaker, this past weekend, Chuck Colson, a former Nixon administration lawyer, founder of Prison Fellowship, and a good friend, passed away.

I first got to know Colson through his incredible ministry. I knew of his

time serving in Maxwell prison in Alabama, and after he was released, I invited him, as a young State legislator in Pennsylvania, to come and speak to a dinner in my district. I had 535 people show up. He spoke and shared the concept that he had gotten as he served in prison of this idea of Prison Fellowship.

He asked me and another fellow to go up to a couple of Federal prisons in Pennsylvania and select four prisoners to bring to Washington for the first time of this group, and I did. I went to Lewisburg and Allenwood, met over six weekends with the little Christian fellowship in those prisons, and they selected two from each prison. One was a bank robber, a hijacker, a labor union racketeer, and a drug dealer.

And without guards, the prison officials permitted me to drive them to Washington. We dropped them off here, left them for a week, and then I came and picked them up and took them back. But this idea of Prison Fellowship started back then. Chuck, when he would speak to me many times, would call me his first prison volunteer.

It was a wonderful ministry. Chuck is going to be greatly missed. Chuck Colson's story is really one of grace, grace that was given to him, that he worked tirelessly to spread across the Nation and across the world. He will be sorely missed.