[Congressional Record (Bound Edition), Volume 163 (2017), Part 9]
[Senate]
[Pages 12612-12613]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        FDA REAUTHORIZATION BILL

  Mr. REED. Mr. President, today, the Senate passed the Food and Drug 
Administration Reauthorization Act of 2017, FDARA, to reauthorize user 
fees and other programs at the FDA to ensure that new, safe, and 
effective treatments get to patients in need as quickly as possible to 
save lives and greatly increase quality of life. While I have long 
preferred that Congress appropriate funding to the FDA for this purpose 
to avoid any conflicts of interest, I have supported user fee bills and 
will do so again today, as it represents a bipartisan pathway for 
timely drug approvals. I am pleased that this legislation increases the 
amount of funding that drug and device companies will contribute to the 
approval process. However, I am disappointed that this legislation does 
not address drug pricing in a comprehensive way, as I have long 
advocated. I will continue to work with my colleagues to press for 
Senate action on this critical issue.
  FDARA includes a number of key provisions I worked on to improve the 
pipeline for new pediatric drugs and devices. In particular, this 
legislation will reauthorize funding for critical pediatric programs 
such as pediatric clinical trials at the National Institutes of Health 
and the Pediatric Device Consortia grants under the FDA. In addition, 
this legislation will spur more pediatric drug development because of 
critical reforms to require drug companies to begin consideration of 
pediatric studies earlier in the drug development process. FDARA also 
takes important steps to spur drug development for and better 
consideration of the needs of neonates, recognizing that treatments for 
infants must be considered differently than for teenagers.
  Having worked for many years to improve access to care for children 
with cancer and childhood cancer survivors, I am also pleased to 
support the bill's new requirements for more pediatric studies on 
treatments for cancer. These provisions are designed to spur new and 
better treatments for children suffering from cancer. However, I 
believe that we should be making these changes to support new 
treatments for all diseases impacting children, not just those with 
cancer. While we were unable to go that far in this bill, we were able 
to add a study of this issue.

[[Page 12613]]

I look forward to seeing the results and working with my colleagues to 
expand these requirements in subsequent legislation. I am also 
concerned that this legislation does nothing to limit the ability of 
drug companies to benefit from exemptions from current pediatric study 
requirements. I filed an amendment to FDARA to close the most egregious 
of these loopholes in which a drug company can technically be exempted 
from pediatric study requirements because the treatment would only be 
used for a rare pediatric condition. I would hope that my colleagues on 
both sides of the aisle could agree that this loophole must be closed.
  FDARA is an important step forward and an example of strong 
bipartisan health legislation in this Congress. I hope that we can 
continue this work, and not return to the partisan efforts to repeal 
the Affordable Care Act that occupied this body for much of the year.
  Mr. MENENDEZ. Mr. President, I am pleased the Senate advanced H.R. 
2430, the FDA Reauthorization Act. This bipartisan, bicameral 
legislation ensures Americans will continue to have access to safe 
medications and the FDA has the tools they need to continue our 
Nation's approval process remains the gold standard. I am also pleased 
to see tropical disease priority review voucher state that a sponsor 
qualifies for a neglected tropical disease priority review voucher 
under existing law until September 30, 2017, so long as they submit at 
least one portion of a human drug application by that date.
  I would like to ask Senator Isakson if it is our intention to allow 
for sponsors who have been working in good faith with the Food and Drug 
Administration on a human drug application for a product that addresses 
a neglected tropical disease to qualify for a priority review voucher, 
as long as they begin a rolling submission to the agency by September 
30, 2017?
  Mr. ISAKSON. Mr. President, as my colleague Senator Menendez 
indicated, the intent of the language in the FDA Reauthorization Act is 
this: so long as the submission process for a given product is begun by 
the sponsor on or before September 30, 2017, the product would qualify 
for a priority review voucher under the neglected tropical disease 
priority review voucher program.
  Mr. MENENDEZ. Mr. President, I thank my colleague, Senator Isakson, 
for clarifying the language. It is important to provide this clarity to 
ensure products, for which at least one portion of the application is 
submitted in accordance with Section 506(d) of the Food, Drug & 
Cosmetic Act by September 30, 2017, qualify for the vouchers under 
current law.

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