[Congressional Record Volume 158, Number 80 (Thursday, May 31, 2012)]
[Extensions of Remarks]
[Pages E917-E918]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     H.R. 5651, THE FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

                                 ______
                                 

                          HON. CHARLES F. BASS

                            of new hampshire

                    in the house of representatives

                         Thursday, May 31, 2012

  Mr. BASS of New Hampshire. Mr. Speaker, I rise in strong support of 
H.R. 5651, the Food and Drug Administration (FDA) Reform Act of 2012. 
The user fee process at the FDA is a vital element in maintaining 
operations at the FDA to bring valuable drugs and devices through the 
approval pathway and to market. I am optimistic that, with the enhanced 
financial incentives and resources available to the FDA included in the 
user fee agreements, we will see shorter approval times and more 
successful products available to patients. Additionally, there are 
significant drug and device regulatory improvements that will, I 
believe, increase transparency, market involvement, and the development 
of innovative and life-saving drugs and devices.
  Consistent throughout this process has been a commitment to bringing 
the need of the rare disease community to the forefront of this debate, 
both through medical device legislation as well as a focus on drug 
development for rare diseases. I am proud to have my bill, the 
Humanitarian Device Reform Act (H.R. 3211), included as a provision in 
the device regulatory section. This language will make it easier for 
device manufacturers to create Humanitarian Use Devices (HUDs) to treat 
individuals, both children and adults, who suffer from diseases that 
affect communities of 4,000 or fewer each year. Current law prevents 
companies who manufacture HUDs from recouping beyond the research and 
development costs, subsequently restricting entry into this field, 
particularly for smaller device companies, such as those found in New 
Hampshire. This provision would lift this outdated profit cap 
restriction and would do so in a way that maintains incentives for 
devices developed for both children and adults and keeps in place the 
necessary product safeguards. It would maintain FDA's current oversight 
of HUDs but, by allowing manufacturers to generate a profit from the 
sale of these devices, allow for further development, improvements, and 
incentives to make it possible for new device developers to enter the 
marketplace, many of which cannot afford to do so under current 
statute.
  During this debate I have made clear my support for rare diseases and 
the focus on drug development and expedited approval pathways for drugs 
to treat rare diseases. With this increased focus on providing 
incentives to manufacturers to invest in the development of these 
drugs, it can be an attainable goal for an individual and family 
affected by rare diseases to not only improve the quality of life but 
possibly even find a cure. By working together, the FDA and drug 
developers will be able to maintain the high standards of safety but 
also fast-track the approval process in order to bring these important 
drugs to the patient.
  While H.R. 5651 makes a number of important reforms, more work needs 
to be done to strengthen the integrity of the drug supply chain. 
Congress must maintain its commitment to keeping the American people 
safe and protect the integrity of drugs, from the manufacturing floor 
to the medicine cabinet. We need more than the prospect of a patchwork 
of state regulations that would prove to be costly and ineffective, and 
more importantly, would fail to get the job done. Instead, we need a 
common sense national tracking system that will provide a consistent 
and workable solution for all parties in the supply chain.
  At the beginning of May, I joined a bipartisan group of my colleagues 
in writing a letter to Chairmen Upton and Pitts and Ranking Members 
Waxman and Pallone stressing the importance of the pharmaceutical 
distribution chain and urging the inclusion of legislative language to 
establish a prescription drug traceability platform. While I had hoped 
an agreement would have been included in the

[[Page E918]]

bill we are considering today, I am encouraged that a compromise can be 
reached during a House and Senate conference.
  Mr. Speaker, I would like to thank my colleagues on the Energy and 
Commerce Committee for the work they have done on this user fee 
agreement and urge its swift passage.

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