[Congressional Record Volume 161, Number 109 (Tuesday, July 14, 2015)]
[Extensions of Remarks]
[Pages E1060-E1061]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         21ST CENTURY CURES ACT

                                 ______
                                 

                               speech of

                          HON. JOSEPH R. PITTS

                            of pennsylvania

                    in the house of representatives

                         Thursday, July 9, 2015

       The House in Committee of the Whole House on the state of 
     the Union had under consideration the bill (H.R. 6) to 
     accelerate the discovery, development, and delivery of 21st 
     century cures, and for other purposes:

  Mr. PITTS. Mr. Chair, I rise in strong support for H.R. 6, the 21st 
Century Cures Act which will help advance the discovery, development, 
and delivery of new treatments and cures for patients and will foster 
private sector innovation here in the U.S.
  Arriving here today has been a long journey--full of lots of steps 
and some twists and turns along the way. I especially want to thank 
Legislative Counsel for their tireless efforts in helping translate our 
legislative aims into legislative language. They worked nights and 
weekends and were consummate professionals throughout the process. 
Specifically, I want to thank the following: Warren Burke, Ed Grossman, 
Jessica Shapiro, Michelle Vanek, Jesse Cross.
  I also want to thank the health care staff of the Congressional 
Budget Office for all their help in recent months. In addition to their 
role in estimating the budgetary effects of numerous policies in the 
bill, they were instrumental in helping us shape a number of proposals 
the Committee considered. I specifically want to thank Holly Harvey, 
Tom Bradley, Chad Chirico, and all their colleagues for their diligence 
and assistance through the process.
  And I would be remiss if I did not again thank the outstanding team 
on Energy and Commerce, and most especially the Health team, led by 
Chief Health Counsel, Clay Alspach, supported by Josh Trent, Paul 
Edattel, John Stone, Robert Horne, Carly McWilliams, Michelle 
Rosenberg, Katie Novaria, Adrianna Simonelli, Traci Vitek and Graham 
Pittman--without whose expertise, wisdom and counsel, this legislative 
work would not be possible.
  H.R. 6 was reported from Energy and Commerce Committee by a vote of 
51-0 and advances conservative fiscal and regulatory reforms. Every 
dollar of advanced appropriations in the bill (which will sunset at the 
end of FY 2020) is offset with other permanent reforms--including 
billions of dollars in mandatory entitlement savings in Medicare and 
Medicaid.
  But this is no ordinary mandatory spending--like the kind we usually 
see in entitlement spending such as Social Security, Medicare, Medicaid 
and Obamacare. This mandatory spending is for five years only and then 
stops or sunsets. This mandatory spending is fully paid for with 
mandatory spending cuts elsewhere that will not stop in five years, but 
are permanent reforms resulting in real savings. By comparison, the 
Ryan-Murray budget deal for health care savings yielded much less.
  This innovative hybrid approach allows us to cut mandatory spending 
(entitlement spending) and use the savings to fund what would otherwise 
be a discretionary project--but in this case is 5-year dedicated 
spending on medical research.
  Congressional Budget Office determined that H.R. 6 will reduce the 
deficit by $500 million over the first ten years, and at least another 
$7 billion over the second decade.
  The funds provided to the National Institutes for Health (NIH) and 
Food and Drug Administration (FDA) will be subject to explicit review 
and reprogramming through the annual appropriations process. Congress 
can review the dedicated funding and allocate it for specific 
initiatives.
  Additionally, all the important policy riders that accompany federal 
funding through appropriations will be included--such as the Hyde 
Amendment and the Dickey-Wicker Amendment.
  This bill also includes a policy that excludes authorized generics 
from Average Manufacturers' Price. This is a common sense policy from 
the President's budget proposal, intended to ensure the appropriate 
calculation of Medicaid brand name rebates paid by manufacturers. The 
policy is not intended to effect Medicaid programs' pharmacy 
reimbursements. Instead, the provision, which many states support, will 
result in an increase in manufacturer rebates under Medicaid and thus 
save money for states and the federal government.

[[Page E1061]]

  H.R. 6 will help America to innovate its way out of our entitlement 
crisis. The regulatory reforms included in H.R. 6 will accelerate the 
pace of discovery, development and delivery of new treatments and 
cures, thereby providing significant health care savings to the federal 
budget that will only grow over time.
  By modernizing clinical trials, eliminating duplicative 
administrative requirements, and perhaps most importantly, making FDA 
less bureaucratic by advancing the voice and needs of patients in the 
drug and device approval process--H.R. 6 will make lasting, positive 
changes to the entire ecosystem of Cures. Over 250 patient groups have 
enthusiastically said ``yes'' and endorsed Cures.
  I urge all of my colleagues to think of the patients and vote ``AYE'' 
in support of H.R. 6.

                          ____________________