SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Findings. 
Sec. 4. Definitions. 
TITLE I—ADVANCING DIAGNOSTICS FOR PATIENTS 
Sec. 101. Developing a common lexicon to facilitate progress on diagnostics. 
Sec. 102. Creating incentives for innovative diagnostics. 
Sec. 103. Promoting the development of innovative diagnostics. 
TITLE II—CAPTURING LOST OPPORTUNITIES FOR PATIENTS 
Sec. 201. Dormant therapies. 
Sec. 202. Study regarding new indications for existing therapies. 
SEC. 3. FINDINGS. 
The Congress makes the following findings: 
(1) More than 133 million Americans, or 45 
percent of the population, have at least one chronic 
condition. A quarter of Americans have multiple 
chronic conditions. 
(2) Chronic diseases have become the leading 
cause of death and disability in the United States. 
Seven out of every 10 deaths are attributable to 
chronic disease. Chronic diseases also compromise 
the quality of life of millions of Americans. 
(3) Despite $80 billion spent annually on re-
search and development, many diseases and condi-
tions lack effective treatments. 
(4) Many commonly used drugs are effective in 
only 50 to 75 percent of the patient population, 
which can lead to devastating long-term side effects, 
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resulting in the potential risks outweighing the bene-
fits for some patients. 
(5) Advanced and innovative diagnostic tests 
have the potential to dramatically increase the effi-
cacy and safety of drugs by better predicting how 
patients will respond to a given therapy. 
(6) Despite their promise, many drugs and 
diagnostics may go undeveloped due to uncertain 
regulatory and reimbursement processes, among 
other reasons. 
(7) In addition, there is reason to believe that 
potential treatments with tremendous value to pa-
tients are never developed or are discontinued during 
research and development due to insufficiencies in 
the intellectual property system. 
(8) It is in the public interest to address the 
hurdles that may be precluding new treatments from 
reaching patients and to remove the disincentives for 
the development of therapies for these unmet needs. 
SEC. 4. DEFINITIONS. 
In this Act: 
(1) The term ‘‘biological product’’ has the 
meaning given to that term in section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
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(2) The term ‘‘drug’’ has the meaning given to 
that term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(3) The term ‘‘medicine’’ means a biological 
product or a drug. 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
TITLE I—ADVANCING 
DIAGNOSTICS FOR PATIENTS 
SEC. 101. DEVELOPING A COMMON LEXICON TO FACILI-
TATE PROGRESS ON DIAGNOSTICS. 
(a) IN GENERAL.—Not later than 180 days after the 
date of enactment of this Act, the Secretary shall establish 
within the Department of Health and Human Services the 
Advanced Diagnostics Education Council (in this section 
referred to as the ‘‘Council’’). 
(b) DUTIES.— 
(1) IN GENERAL.—The Council shall promote 
an improved understanding of key concepts related 
to innovative diagnostics by recommending standard 
terms and definitions for use by patients, physicians, 
health care providers, payers, and policymakers. 
(2) GUIDE.—The Secretary shall publish and 
disseminate a guide regarding such recommended 
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terms and definitions for patients, physicians, health 
care providers, payers, and policymakers. 
(3) REPORT.—Not later than 12 months after 
the establishment of the Council, the Secretary shall 
prepare and submit a report to the Congress and to 
the public on the Council’s deliberations, activities, 
and determinations with respect to meeting its du-
ties described in paragraphs (1) and (2). 
(c) CHAIRPERSON.—The Secretary, or the Sec-
retary’s designee, shall serve as chairperson of the Coun-
cil. 
(d) MEMBERS.—In addition to the Secretary, the 
Council shall consist of the following: 
(1) The head of each the following agencies (or 
a designee thereof): 
(A) The National Institutes of Health. 
(B) The Centers for Disease Control and 
Prevention. 
(C) The Food and Drug Administration. 
(D) The Agency for Healthcare Research 
and Quality. 
(E) The Centers for Medicare & Medicaid 
Services. 
(F) The Department of Defense. 
(G) The Department of Veterans Affairs. 
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(H) The Health Resources and Services 
Administration. 
(I) The Substance Abuse and Mental 
Health Services Administration. 
(J) The Indian Health Service. 
(2) Seven members appointed by the Secretary 
from among individuals who collectively— 
(A) represent a broad range of perspec-
tives; and 
(B) have expertise in— 
(i) basic and translational research, 
including with respect to molecular biology 
and genetics; 
(ii) bioinformatics; 
(iii) the discovery, development, and 
commercialization of in vitro diagnostics; 
and 
(iv) law and ethics. 
(3) Four members appointed by the Secretary 
who are each a chief medical or scientific officer of 
a patient advocacy organization. 
(e) PUBLIC INPUT.—In carrying out its duties, the 
Council shall solicit input from relevant stakeholders and 
the public. 
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SEC. 202. STUDY REGARDING NEW INDICATIONS FOR EX-
ISTING THERAPIES. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary shall enter into an ar-
rangement with the Institute of Medicine (or, if the Insti-
tute declines, another appropriate entity)— 
(1) to conduct a study on intellectual property 
laws and their impact on therapy and diagnostic de-
velopment in order to formulate recommendations on 
how to facilitate the clinical evaluation and develop-
ment of therapies currently available on the market 
for new potential indications; and 
(2) not later than 18 months after such date of 
the enactment, to submit a report to the Secretary 
and the Congress containing the results of such 
study. 
Æ 
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