Commemorating the 20th anniversary of the Orphan Drug Act and the National Organization for Rare Disorders.

Mr. Speaker, I thank the gentleman from Florida (Mr. Bilirakis), who is known as Mr. Health in Florida, for the gentleman's help on this important issue.

I rise today in support of H. Con. Res. 147, a bill recognizing the 20th anniversary of the enactment of the Orphan Drug Act and the creation of the National Organization for Rare Disorders.

For many years, 25 million plus Americans suffering from more than 6,000 rare diseases and disorders, including Huntington's disease, ALS, known as Lou Gehrig's disease, Tourettes syndrome and muscular dystrophy, were denied access to effective medicines because prescription drug manufacturers could rarely make a profit from marketing drugs for such small groups of patients.

A rare disease is a disease that affects a population of less than 200,000 people. Currently, one in nine Americans have a rare disease. Due to the low number of affected patients, the prescription drug industry did not adequately fund research into such treatments. Despite the urgent health need for these medicines, they became known as orphan drugs because no company would commercialize them.

On January 4, 1983, Congress passed and President Ronald Reagan signed into law the Orphan Drug Act. This legislation created financial incentives for research and production of such orphan drugs. In addition, a new Federal program at the National Institutes of Health and the Food and Drug Administration encouraged clinical research and commercial product development for products that target rare diseases.

As a result of this incredible law, which was produced in coordination with Congress, the White House and the pharmaceutical industry, over 238 drugs, biologics, foods and devices now exist, as compared to less than 40 therapies that existed before the law was enacted. Undoubtedly, this can easily be described as one of the most effective laws this Chamber has ever passed.

Mr. Speaker, I would like to recognize an organization which has been committed to bringing a voice to the most underserved medical population in the world, those suffering from rare diseases, the National Organization for Rare Diseases.

NORD, established soon after the signing of the Orphan Drug Act, is a federation of voluntary health organizations dedicated to helping people with orphan diseases and conditions and assisting the organizations that serve them.

NORD has been and will continue to be committed to the identification, treatment, and cure of orphan diseases and conditions through programs of education, advocacy, research and service.

Mr. Speaker, I would also like to take a moment to thank the gentleman from Louisiana (Chairman Tauzin), the gentleman from Florida (Mr. Bilirakis), the ranking member, the gentleman from California (Mr. Waxman), and, of course, the gentleman from Illinois (Mr. Shimkus) for their effective work and advocacy of this issue. I would also like to thank Bradley Schrieber, my legislation counsel, who joins me on the floor today, who first brought this legislation to my attention.

For me, it is a personal sense of pride, because it was the first bill that was a freestanding bill that I authored that was signed into law, and I have the momentous pen in my office. I can look back on my career in Congress and know that in some small way we played a critical role in helping those voices who may be in the minority but are suffering just as those who are suffering from better-known diseases, if you will. I am delighted to be part of this, and I am glad it was brought to the floor today, and I encourage all of my colleagues to join me in recognizing this very important year for the millions of men and women and children in this medical minority.

Mr. Speaker, I rise today in strong support of H. Con. Res. 147, Commemorating the 20th Anniversary of the Orphan Drug Act and the National Organization for Rare Disorders. This resolution honors an exemplary organization that has vastly improved the lives of millions of Americans with rare diseases and their families.

The Orphan Drug Act of 1983 filled a void in our health care system-- the fact that drug companies were unwilling or unable to invest in developing products to treat rare diseases. The incentives that the Orphan Drug Act put into place have made dramatic improvements in the availability of treatments for the 25 million Americans affected by rare diseases. In the decade before the Orphan Drug Act was signed into law, ten treatments for orphan disease were developed. In the last 20 years, more than 200 treatments for rare diseases have been approved by the FDA, and more than 900 more are in development.

The National Organization of Rare Disorders has represented a lifeline for millions of families since its inception in 2003. It has been instrumental in providing information about diseases and their treatments, and for connecting individuals impacted by rare disorders with advocacy organizations and with each other, allowing patients and families to gain invaluable support and advice from those suffering from the same conditions. It has connected patients with drug assistance programs, to help them to access life improving drugs that they otherwise could not afford.

I want to draw particular attention to the various disorders characterized as types of epilepsy. The Orphan Drug Act has been instrumental in the development of epilepsy treatments such as sodium valproate and a gel form of diazepam, or Valium. But, for epilepsy and thousands of other disorders, there is much more work to be done. New evidence of the damaging long-term effects of seizures represents an additional call to action to develop better treatments for the various epileptic disorders. Twenty-five percent of epilepsy patients have uncontrolled seizures, and even those for whom medicine or surgery are effective still suffer seizures and their damaging effects.

Mr. Speaker, I thank Congressman Foley and the entire Energy and Commerce Committee for introducing this important resolution and bringing it to the floor today. And I applaud the perseverance of NORD founder

Abbey Meyers and the other courageous individuals who advocated for the passage of the Orphan Drug Act and have given a brighter future to millions of American families over the last 20 years. For these reasons, I strongly encourage my colleagues to vote for H. Con. Res. 147.

Mr. Speaker, I move to suspend the rules and agree to the concurrent resolution (H. Con. Res. 147) commemorating the 20th Anniversary of the Orphan Drug Act and the National Organization for Rare Disorders, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on H. Con. Res. 147.

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

Mr. Speaker, I rise in support of H. Con. Res. 147 which commemorates the 20th anniversary of the Orphan Drug Act and the National Organization for Rare Disorders. This legislation, introduced by the gentleman from Florida (Mr. Foley), was unanimously approved by the Committee on Energy and Commerce on April 30 of this year.

H. Con. Res. 147 recognizes the great contribution the Orphan Drug Act has made to the rare disease community. In the decade before the Orphan Drug Act was enacted, only 10 new treatments for orphan diseases were developed. In the 20 years since it was passed, more than 200 new drugs, foods and devices have been approved by the Food & Drug Administration, and an additional 900 are in various stages of development.

These treatments for rare disorders treat an estimated 11 million patients in the United States. Eighty-five percent of orphan drugs are being used to treat serious or life-threatening diseases, 31 percent treat rare forms of cancer, and approximately 50 percent are approved for pediatric uses.

Last year President Bush signed into law two important bills dealing with rare diseases. The Rare Diseases Act of 2002 established an Office of Rare Diseases at the National Institutes of Health, while the Rare Diseases Orphan Product Development Act of 2002 increased funding for the Food and Drug Administration's Orphan Product Research Grants Program. I am glad we are following the enactment of these important bills by recognizing both the original Orphan Drug Act and the National Organization for Rare Disorders, which has advocated tirelessly for the victims of rare diseases.

Mr. Speaker, I urge all of my colleagues to support this important resolution.

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

Mr. Speaker, I yield such time as he may consume to the gentleman from Florida (Mr. Foley), the writer of this resolution.

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

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

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

Mr. Speaker, I thank the gentleman from Florida (Mr. Bilirakis) for his work on this bill. I am proud to support H. Con. Res. 147, legislation which commemorates the 20th anniversary of the Orphan Drug Act and the National Organization for Rare Disorders.

Approximately 25 million Americans suffer from more than 6,000 rare diseases. These diseases include Huntington's disease, Lou Gehrig's disease, cystic fibrosis, and Duchenne muscular dystrophy. Because of the relatively small patient populations associated with rare diseases, pharmaceutical firms are concerned about receiving an adequate return on their investment in developing medications to treat them.

In response to this problem, Congress passed the Orphan Drug Act on January 4, 1983, which allows for incentives, such as market exclusivity, for products developed for rare diseases. Additionally, the Food and Drug Administration has been able to support small clinical trials through Orphan Products Research Grants. The Orphan Drug Act has been effective, leading to the development of more than 183 drugs and four medical devices for rare diseases.

I also note that the gentleman from California (Mr. Waxman) was a key leader in the development of the Orphan Drug Act. The success and longevity of the Orphan Drug Act are a tribute to his skillful work on this legislation 2 decades ago.

We are also here today to recognize and commemorate the National Organization for Rare Disorders. NORD is a unique federation of voluntary health organizations dedicated to helping people with rare, also known as ``orphan'', diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment and cure of rare disorders through programs of education, advocacy, research and service.

The purpose of this legislation is to recognize the contributions that the Orphan Drug Act has made to the rare disease community and to commemorate the 20th anniversary of both the Orphan Drug Act and the National Organization of Rare Disorders. I urge all of my colleagues to join me in support of H. Con. Res. 147.

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

Mr. Speaker, I yield 2 minutes to the gentleman from California (Mr. Waxman).

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. Speaker, I ask my colleagues to join me in voting for Hon. Con. Res. 147, commemorating the 20th anniversary of the Orphan Drug Act and the National Organization for Rare Diseases. As the principal author of the Orphan Drug Act, I am extremely proud of what has been achieved as a result of this landmark legislation.

Almost one in 10 of us is afflicted with what are called rare diseases, diseases that affect fewer than 200,000 people. And yet before 1983 if you were unlucky enough to suffer from such a disease, you had little or no hope that a treatment or cure would be developed. The market for a drug for an individual with a rare disease simply was not large enough for the pharmaceutical companies to justify the high cost of developing a potential treatment.

The Orphan Drug Act was the first in a line of important laws that utilized creative new market incentives to encourage pharmaceutical innovation. No one was more important in the fight to pass orphan drug legislation than Abbey Meyers and the group she founded, the National Organization for Rare Disorders, or NORD. For the last 20 years, NORD has fought tirelessly for people with rare diseases, supported research, pushed for Federal funding and spread information about rare diseases. NORD's work, and the strides we have made against rare diseases thanks to the Orphan Drug Act, justly deserve to be honored in this resolution. I want to join my colleagues in urging that this matter be passed by the House.