[Congressional Record Volume 162, Number 175 (Tuesday, December 6, 2016)]
[Extensions of Remarks]
[Page E1602]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          TSUNAMI WARNING, EDUCATION, AND RESEARCH ACT OF 2015

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                               speech of

                            HON. BILLY LONG

                              of missouri

                    in the house of representatives

                      Wednesday, November 30, 2016

  Mr. LONG. Madam Speaker, I rise today in strong support of the 21st 
Century Cures Act and to congratulate my friends Chairman Fred Upton 
and Congresswoman Diana DeGette for their tireless work on this crucial 
legislation.
  Specifically I would like to discuss Section 3037 of the Act which is 
modeled after my legislation, H.R. 2452 which would amend the Federal 
Food, Drug and Cosmetic Act to facilitate better dissemination of 
health care economic information. This provision serves an important 
public health purpose--namely, ensuring payors and other population 
health decision-makers have relevant data to assist them in making 
informed decisions on behalf of patients.
  Relevant scientific information such as that related to quality of 
life, cost-effectiveness, and treatment outcomes can inform coverage 
decisions and improve healthcare costs and patient outcomes. By 
requiring only that such information relates to an approved indication, 
and by making other changes, this section broadens the scope of 
information that can be communicated without being considered false or 
misleading.
  In particular, the omission of the word ``directly'' from the 
requirement in existing law that information be ``directly related'' to 
an approved indication means that information that is consistent with 
an approved use, but not in the labeling itself, falls within the scope 
of information that can be communicated to payors and other population 
health decision-makers.
  This provision ensures that information providing valuable insight 
regarding new medicines can be appropriately communicated under the 
Federal Food, Drug, and Cosmetic Act, and I thank Chairman Upton for 
its ultimate inclusion in this package.

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