SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Strengthening Health 
Care and Lowering Prescription Drug Costs Act’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—LOWERING PRESCRIPTION DRUG COSTS 
Subtitle A—Bringing Low-Cost Options and Competition While Keeping 
Incentives for New Generics 
Sec. 101. Change conditions of first generic exclusivity to spur access and com-
petition. 
Subtitle B—Protecting Consumer Access to Generic Drugs 
Sec. 111. Unlawful agreements. 
Sec. 112. Notice and certification of agreements. 
Sec. 113. Forfeiture of 180-day exclusivity period. 
Sec. 114. Commission litigation authority. 
Sec. 115. Statute of limitations. 
Subtitle C—Creating and Restoring Equal Access to Equivalent Samples 
Sec. 121. Actions for delays of generic drugs and biosimilar biological products. 
Sec. 122. REMS approval process for subsequent filers. 
Sec. 123. Rule of construction. 
Subtitle D—Study on Role of Federal Assistance in Drug Development 
Sec. 131. Study on role of Federal assistance in drug development. 
Subtitle E—Pharmacy School Outreach 
Sec. 141. Pharmacy school outreach. 
Subtitle F—Reports 
Sec. 151. Effects of increases in prescription drug price. 
TITLE II—HEALTH INSURANCE MARKET STABILIZATION 
Sec. 201. Preserving State option to implement health care marketplaces. 
Sec. 202. Providing for additional requirements with respect to the navigator 
program. 
Sec. 203. Federal Exchange outreach and educational activities and annual en-
rollment targets. 
Sec. 204. Short-term limited duration insurance rule prohibition. 
Sec. 205. Protection of health insurance coverage in certain Exchanges. 
Sec. 206. Sense of Congress relating to the practice of silver loading. 
Sec. 207. Consumer outreach, education, and assistance.
Sec. 208. GAO report. 
Sec. 209. Report on the effects of website maintenance during open enrollment. 
TITLE III—BUDGETARY EFFECTS 
Sec. 301. Determination of budgetary effects. 
TITLE I—LOWERING 
PRESCRIPTION DRUG COSTS 
Subtitle A—Bringing Low-Cost Op-
tions and Competition While 
Keeping 
Incentives 
for 
New 
Generics 
SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLU-
SIVITY TO SPUR ACCESS AND COMPETITION. 
Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend-
ed— 
(1) in subclause (I), by striking ‘‘180 days 
after’’ and all that follows through the period at the 
end and inserting the following: ‘‘180 days after the 
earlier of— 
‘‘(aa) the date of the first com-
mercial marketing of the drug (includ-
ing the commercial marketing of the 
listed drug) by any first applicant; or 
‘‘(bb) the applicable date speci-
fied in subclause (III).’’; and 
(2) by adding at the end the following new sub-
clause:
‘‘(III) APPLICABLE DATE.—The appli-
cable date specified in this subclause, with 
respect to an application for a drug de-
scribed in subclause (I), is the date on 
which each of the following conditions is 
first met: 
‘‘(aa) The approval of such an 
application could be made effective, 
but for the eligibility of a first appli-
cant for 180-day exclusivity under 
this clause. 
‘‘(bb) At least 30 months have 
passed since the date of submission of 
an application for the drug by at least 
one first applicant. 
‘‘(cc) Approval of an application 
for the drug submitted by at least one 
first applicant is not precluded under 
clause (iii). 
‘‘(dd) No application for the drug 
submitted by any first applicant is ap-
proved at the time the conditions 
under items (aa), (bb), and (cc) are 
all met, regardless of whether such an
application 
is 
subsequently 
ap-
proved.’’. 
Subtitle B—Protecting Consumer 
Access to Generic Drugs 
SEC. 111. UNLAWFUL AGREEMENTS. 
(a) AGREEMENTS PROHIBITED.—Subject to sub-
sections (b) and (c), it shall be unlawful for an NDA or 
BLA holder and a subsequent filer (or for two subsequent 
filers) to enter into, or carry out, an agreement resolving 
or settling a covered patent infringement claim on a final 
or interim basis if under such agreement— 
(1) a subsequent filer directly or indirectly re-
ceives from such holder (or in the case of such an 
agreement between two subsequent filers, the other 
subsequent filer) anything of value, including a li-
cense; and 
(2) the subsequent filer agrees to limit or fore-
go research on, or development, manufacturing, 
marketing, or sales, for any period of time, of the 
covered product that is the subject of the application 
described in subparagraph (A) or (B) of subsection 
(g)(8). 
(b) EXCLUSION.—It shall not be unlawful under sub-
section (a) if a party to an agreement described in such 
subsection demonstrates by clear and convincing evidence
that the value described in subsection (a)(1) is compensa-
tion solely for other goods or services that the subsequent 
filer has promised to provide. 
(c) LIMITATION.—Nothing in this section shall pro-
hibit an agreement resolving or settling a covered patent 
infringement claim in which the consideration granted by 
the NDA or BLA holder to the subsequent filer (or from 
one subsequent filer to another) as part of the resolution 
or settlement includes only one or more of the following: 
(1) The right to market the covered product 
that is the subject of the application described in 
subparagraph (A) or (B) of subsection (g)(8) in the 
United States before the expiration of— 
(A) any patent that is the basis of the cov-
ered patent infringement claim; or 
(B) any patent right or other statutory ex-
clusivity that would prevent the marketing of 
such covered product. 
(2) A payment for reasonable litigation ex-
penses not to exceed $7.5 million in the aggregate. 
(3) A covenant not to sue on any claim that 
such covered product infringes a patent. 
(d) ENFORCEMENT BY FEDERAL TRADE COMMIS-
SION.—
(1) GENERAL APPLICATION.—The requirements 
of this section apply, according to their terms, to an 
NDA or BLA holder or subsequent filer that is— 
(A) a person, partnership, or corporation 
over which the Commission has authority pur-
suant to section 5(a)(2) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(2)); or 
(B) a person, partnership, or corporation 
over which the Commission would have author-
ity pursuant to such section but for the fact 
that such person, partnership, or corporation is 
not organized to carry on business for its own 
profit or that of its members. 
(2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES 
ENFORCEMENT AUTHORITY.— 
(A) IN GENERAL.—A violation of this sec-
tion shall be treated as an unfair or deceptive 
act or practice in violation of section 5(a)(1) of 
the Federal Trade Commission Act (15 U.S.C. 
45(a)(1)). 
(B) POWERS OF COMMISSION.—Except as 
provided in subparagraph (C) and paragraphs 
(1)(B) and (3)— 
(i) the Commission shall enforce this 
section in the same manner, by the same
means, and with the same jurisdiction, 
powers, and duties as though all applicable 
terms and provisions of the Federal Trade 
Commission Act (15 U.S.C. 41 et seq.) 
were incorporated into and made a part of 
this section; and 
(ii) any NDA or BLA holder or subse-
quent filer that violates this section shall 
be subject to the penalties and entitled to 
the privileges and immunities provided in 
the Federal Trade Commission Act. 
(C) JUDICIAL REVIEW.—In the case of a 
cease and desist order issued by the Commis-
sion under section 5 of the Federal Trade Com-
mission Act (15 U.S.C. 45) for violation of this 
section, a party to such order may obtain judi-
cial review of such order as provided in such 
section 5, except that— 
(i) such review may only be obtained 
in— 
(I) the United States Court of 
Appeals for the District of Columbia 
Circuit; 
(II) the United States Court of 
Appeals for the circuit in which the
ultimate parent entity, as defined in 
section 801.1(a)(3) of title 16, Code 
of Federal Regulations, or any suc-
cessor thereto, of the NDA or BLA 
holder (if any such holder is a party 
to such order) is incorporated as of 
the date that the application described 
in subparagraph (A) or (B) of sub-
section (g)(8) or an approved applica-
tion that is deemed to be a license for 
a biological product under section 
351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) pursuant to 
section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act 
of 2009 (Public Law 111–148; 124 
Stat. 817) is submitted to the Com-
missioner of Food and Drugs; or 
(III) the United States Court of 
Appeals for the circuit in which the 
ultimate parent entity, as so defined, 
of any subsequent filer that is a party 
to such order is incorporated as of the 
date that the application described in 
subparagraph (A) or (B) of subsection
(g)(8) is submitted to the Commis-
sioner of Food and Drugs; and 
(ii) the petition for review shall be 
filed in the court not later than 30 days 
after such order is served on the party 
seeking review. 
(3) ADDITIONAL ENFORCEMENT AUTHORITY.— 
(A) CIVIL
PENALTY.—The Commission 
may commence a civil action to recover a civil 
penalty in a district court of the United States 
against any NDA or BLA holder or subsequent 
filer that violates this section. 
(B) SPECIAL
RULE
FOR
RECOVERY
OF 
PENALTY
IF
CEASE
AND
DESIST
ORDER 
ISSUED.— 
(i) IN GENERAL.—If the Commission 
has issued a cease and desist order in a 
proceeding under section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) for 
violation of this section— 
(I) the Commission may com-
mence a civil action under subpara-
graph (A) to recover a civil penalty 
against any party to such order at 
any time before the expiration of the
1-year period beginning on the date 
on which such order becomes final 
under section 5(g) of such Act (15 
U.S.C. 45(g)); and 
(II) in such civil action, the find-
ings of the Commission as to the ma-
terial facts in such proceeding shall be 
conclusive, unless— 
(aa) the terms of such order 
expressly provide that the Com-
mission’s findings shall not be 
conclusive; or 
(bb) such order became final 
by reason of section 5(g)(1) of 
such Act (15 U.S.C. 45(g)(1)), in 
which case such findings shall be 
conclusive if supported by evi-
dence. 
(ii) RELATIONSHIP TO PENALTY FOR 
VIOLATION
OF
AN
ORDER.—The penalty 
provided in clause (i) for violation of this 
section is separate from and in addition to 
any penalty that may be incurred for viola-
tion of an order of the Commission under
section 5(l) of the Federal Trade Commis-
sion Act (15 U.S.C. 45(l)). 
(C) AMOUNT OF PENALTY.— 
(i) IN GENERAL.—The amount of a 
civil penalty imposed in a civil action under 
subparagraph (A) on a party to an agree-
ment described in subsection (a) shall be 
sufficient to deter violations of this section, 
but in no event greater than— 
(I) if such party is the NDA or 
BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
the greater of— 
(aa) three times the value 
received by such NDA or BLA 
holder (or by such subsequent 
filer) that is reasonably attrib-
utable to the violation of this sec-
tion; or 
(bb) three times the value 
given to the subsequent filer (or 
to the other subsequent filer)