[Congressional Record (Bound Edition), Volume 160 (2014), Part 12]
[House]
[Pages 17399-17400]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              THE OPEN ACT

  The SPEAKER pro tempore. The Chair recognizes the gentleman from 
Florida (Mr. Bilirakis) for 5 minutes.
  Mr. BILIRAKIS. Mr. Speaker, I rise today to talk about the 30 million 
Americans who suffer from a rare disease. One in ten, Mr. Speaker, 10 
percent of the country suffers from a rare disease.
  Over 95 percent of these diseases have no treatments because each 
rare disease impacts a small number of patients. That is why I 
introduced the OPEN Act, the Orphan Product Extensions Now Accelerating 
Cures and Treatments.
  My bill has the potential to help millions of people, and the idea 
was born from an event in my district. Over the summer, I held two 21st 
Century Cures roundtables in my district. The 21st Century Cures is a 
bipartisan initiative to examine and improve the discovery-development-
delivery cycle.
  Treatments for patients suffering from chronic and rare diseases, 
whether it is from medical devices or medicine, must be discovered on 
the ground level through basic science; developed

[[Page 17400]]

into a practical, usable, and marketable product; and delivered to the 
patients so that the treatment may be effectively utilized.
  Mr. Speaker, the first roundtable featured patients and patient 
advocates. From some of those patients, I heard about the importance of 
repurposing drugs. This led to the introduction of the OPEN Act. My 
bill will leverage the free market to incentivize drugs to be 
repurposed to treat rare diseases and pediatric cancers.
  Repurposing drugs has a twofold benefit. First, the OPEN Act has the 
potential to result in new treatments for individuals with rare 
diseases. As I mentioned, the vast majority of individuals suffering 
from rare diseases don't have treatments, let alone cures; yet I hear 
often about individuals with rare diseases who will take medication 
that has not been tested for their condition.
  The OPEN Act incentivizes the testing of mainstream drugs on rare 
diseases. This bill opens the door for new treatments. The OPEN Act can 
also create a new surge in biotechnology jobs and investments. Creating 
jobs and helping the sick are laudable goals, Mr. Speaker. My bill 
takes a step toward accomplishing that.
  This bill can help millions of people. It will ensure repurposed 
medications are safe and effective for rare conditions and can be 
reimbursed through insurance coverage--so important. This is a 
bipartisan piece of legislation which I introduced with my colleagues, 
Mr. Butterfield, Mr. McCaul, and Mr. Hastings.
  Helping those with rare diseases is a cause worth supporting, and I 
am proud to have introduced the OPEN Act.

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