[House Report 116-693]
[From the U.S. Government Publishing Office]
116th Congress } { Rept. 116-693
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
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PRESERVE ACCESS TO AFFORDABLE GENERICS AND BIOSIMILARS ACT
_______
December 24, 2020.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Nadler, from the Committee on the Judiciary, submitted the
following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany H.R. 2375]
[Including cost estimate of the Congressional Budget Office]
The Committee on the Judiciary, to whom was referred the
bill (H.R. 2375) to prohibit prescription drug companies from
compensating other prescription drug companies to delay the
entry of a generic drug, biosimilar biological product, or
interchangeable biological product into the market, having
considered the same, reports favorably thereon without
amendment and recommends that the bill do pass.
TABLE OF CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for the Legislation.......................... 2
Hearings......................................................... 8
Committee Consideration.......................................... 8
Committee Votes.................................................. 9
Committee Oversight Findings..................................... 9
New Budget Authority and Tax Expenditures........................ 9
Congressional Budget Office Cost Estimate........................ 9
Duplication of Federal Programs.................................. 11
Performance Goals and Objectives................................. 11
Advisory on Earmarks............................................. 11
Section-by-Section Analysis...................................... 12
Changes in Existing Law Made by the Bill, as Reported............ 14
Additional Views................................................. 79
Purpose and Summary
H.R. 2375, the ``Preserve Access to Affordable Generics and
Biosimilars Act,'' is designed to address the soaring cost of
prescription drugs by targeting reverse-payment patent
settlement agreements (``reverse-payment agreements''), also
referred to as ``pay-for-delay'' agreements. Reverse-payment
agreements occur when a pharmaceutical drug company pays a
competitor to keep a generic (or biosimilar) version of its
drug off the market as part of a patent settlement agreement.
These deals delay access to more affordable generic (or
biosimilar) versions of the drugs, costing consumers and the
government billions of dollars in higher drug costs. H.R. 2375
is supported by a coalition of healthcare providers, patient
groups, and public-interest organizations including AARP,
Consumer Reports, Public Citizen, Patients for Affordable Drugs
Now, Premier Inc. Healthcare Alliance, and the American Academy
of Dermatology Association.
Background and Need for the Legislation
BACKGROUND
Reverse payment patent settlements arise in the context of
patent litigation between pharmaceutical drug companies. These
financial arrangements often take the form of a patent
litigation settlement agreement in which the branded drug firm
pays its potential generic competitor to settle patent claims
and delay entering the market with a lower-cost generic
product. Notably, such agreements could also occur between
manufacturers of biologic or biosimilar drugs, or manufacturers
of competing generic (or biosimilar) products. According to a
Federal Trade Commission (FTC) report in 2010, pay-for-delay
agreements were estimated to cost American consumers $3.5
billion per year--$35 billion over the decade from 2010 to
2020.\1\
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\1\Fed. Trade Comm'n, Pay-for-Delay: How Drug Company Pay-Offs Cost
Consumers Billions 2 (2010), https://www.ftc.gov/sites/default/files/
documents/reports/pay-delay-how-drug-company-pay-offs-cost-consumers-
billions-federal-trade-commission-staff-study/100112payfordelayrpt.pdf.
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The Role of Generic and Biosimilar Competition in Lowering Prescription
Drug Costs
Pay-for-delay agreements seek to block or delay price-
reducing generic and biosimilar entry. Because generic
competition is critical to reducing the high cost of
prescription drugs this conduct is particularly harmful.
Generic drugs typically cost 80 to 85% less than their brand-
name alternatives.\2\ Lower-priced generic drugs saved the U.S.
health care system about $1.7 trillion from 2007 to 2016.\3\
Because of the universal recognition that generic competition
is beneficial for patients and taxpayers, Congress and state
legislatures have enacted legislation to facilitate the ability
of drug makers to bring generic and biosimilar prescription
drug products to market.
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\2\Generic Drugs: Questions & Answers, U.S. Food & Drug Admin.
(2018), https://www.fda.gov/drugs/questions-answers/generic-drugs-
questions-answers.
\3\Id.
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The Federal Food, Drug, and Cosmetic Act (FDCA),\4\ as
amended by the Drug Price Competition and Patent Term
Restoration Act of 1984 (Hatch-Waxman Act)\5\ and the Medicare
Prescription Drug, Improvement, and Modernization Act of
2003,\6\ has established procedures to facilitate competition
from lower-priced generic drug manufacturers, while maintaining
incentives for branded drug manufacturers to invest in
developing new drugs.
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\4\21 U.S.C. Sec. 301 (2019).
\5\Id. at Sec. 355.
\6\Id. at Sec. 355(b)(2), (j); 35 U.S.C. Sec. 271(e) (2019).
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Biologics are governed by the Biologics Price Competition
and Innovation Act (BPCIA), rather than the Hatch-Waxman
Act.\7\ Similar to the Hatch-Waxman Act, the BPCIA establishes
procedures to facilitate competition from drug manufacturers of
lower-priced biosimilars (or interchangeables), while
maintaining incentives for branded drug manufacturers to invest
in developing new biological drug products.
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\7\See Patient Protection and Affordable Care Act (PPACA), Pub. L.
No. 111-148, 124 Stat. 119,804 (2010) (codified as amended in scattered
sections of the U.S. Code) (BPCIA was enacted under Title VII of
PPACA).
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The Hatch-Waxman Act has succeeded in facilitating generic
competition and generating large savings for patients, health
care plans, and federal and state governments. Among other
provisions, the Act includes a mechanism for accelerated
approval of generic drugs through an Abbreviated New Drug
Application (ANDA) process. Although the BCPIA is relatively
new, the legislation has facilitated biosimilar competition to
expensive biologic products, also resulting in savings.
Due to these significant price advantages and cost savings,
many third-party payers for prescription drugs--health
insurance plans and Medicaid programs--have adopted policies to
encourage the substitution of generic drugs for their branded
counterparts. In addition, all fifty states and the District of
Columbia have drug substitution laws that encourage and
facilitate the substitution of lower-cost generic drugs for
branded drugs. Consequently, generic drugs typically capture
over 80% of a branded drug's share of unit and dollar sales
within six months of market entry.\8\ Meanwhile, according to a
2016 Journal of the American Medical Association analysis, 72%
of drug spending comes from just 10% of brand-name
medications.\9\ Consequently, there is significant money at
stake in the battle between branded and generic drug
manufacturers.
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\8\Generics Grab 80% Share of US Market and Fill 78% of
Prescriptions, Generics and Biosimilars Initiative (May 13, 2011),
http://gabionline.net/Reports/Generics-grab-80-share-of-US-market-and-
fill-78-of-prescriptions. (citing a report published by IMS Health in
April 2011); see also U.S. Dep't of Health and Human Servs., ``Some
Observations Related to the Generic Drug Market 4 (2015), https://
aspe.hhs.gov/system/files/pdf/139331/ib_GenericMarket.pdf (on average
the generic product captures 90% of the market within one year of
entry).
\9\Aaron S. Kesselheim et al., The High Cost of Prescription Drugs
in the United States: Origins and Prospects for Reform, 316 J. A. Med.
Ass'n 858, 860 (2016), https://phhp-bahealthscience-
new.sites.medinfo.ufl.edu/files/2016/09/jsc1600151.pdf.
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The Statutory Framework in Which Pay-for-Delay Agreements Arise
The patent litigation that gives rise to these types of
agreements usually occurs within the framework that the Hatch-
Waxman Act established for generic entry.\10\ Under Hatch-
Waxman, a generic competitor may seek entry before the
expiration of a brand-name drug's patents. To seek Food and
Drug Administration (FDA) approval for entry before the patents
expire, a generic must declare that its product does not
infringe the relevant patents or that the patents are
invalid.\11\ Branded drug companies often challenge the
generic's declaration, resulting in litigation between the
brand-name and generic drug makers to determine whether the
patents at issue are valid or infringed. This is often referred
to as ANDA litigation because it arises under the FDA's
Abbreviated New Drug Application (ANDA) process. Hatch-Waxman
incentivizes generics to challenge the branded company's
patents, and risk ANDA litigation, because the Act provides
that the first generic to file its application can obtain a
180-day period of market exclusivity--during which it is the
only generic on the market.\12\ For the brand-name company to
win the ANDA litigation and block generic entry, it must defend
the validity of its patents and show that the generic's product
would infringe those patents.
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\10\The Drug Price Competition and Patent Term Restoration Act of
1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at
21 U.S.C. Sec. 355 (2019)) (governing how generics may enter the
marketplace to compete with brand-name pharmaceuticals).
\11\21 U.S.C. Sec. 355(j)(2)(A)(vii)(IV) (2019).
\12\Id. at Sec. 355(j)(5)(B)(iv).
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Because of the expense and uncertain outcome of patent
litigation, brand-name and generic pharmaceutical companies
sometimes settle the litigation before a court reaches a final
decision. In the absence of compensation to the generic for
delaying its entry, it is unlikely that these settlement
agreements would raise antitrust issues.\13\
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\13\See Fed. Trade Comm'n v. Actavis, Inc., 570 U.S. 136, 158
(2013) (``[T]he fact that a large, unjustified reverse payment risks
antitrust liability does not prevent litigating parties from settling
their lawsuit. They may, as in other industries, settle in other ways,
for example, by allowing the generic manufacturer to enter the
patentee's market prior to the patent's expiration, without the
patentee paying the challenger to stay out prior to that point.'').
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Due to the significant loss of market share and profits
that branded manufacturers experience upon entry of generic
competitors, however, some of these settlement agreements are
anti-competitive, involving brand-name drug companies
committing to pay the generic manufacturer a fee to delay the
marketing of its generic version of the drug for a given period
of time. Markus Meier, who leads the FTC's health care division
and previously served as Acting Director of the FTC's Bureau of
Competition, testified last Congress that ``[b]randed
manufacturers have used such agreement [sic] to buy more
protection from competition than their patent rights provide,
at the expense to competition and consumers.''\14\ A recent FTC
opinion explained why these pay-for-delay agreements are also
referred to as ``reverse payment'' settlements:
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\14\Antitrust Concerns and the FDA Approval Process: Hearing Before
the Subcomm. on Regulatory Reform, Commercial, and Antitrust Law of the
H. Comm. on the Judiciary, 115th Cong. (2017) (written testimony of
Markus Meier, Acting Director, Bureau of Competition, Fed. Trade
Comm'n, at 15), https://republicans-judiciary.house.gov/wp-content/
uploads/2017/07/Meier-FTC-Testimony.pdf.
In a reverse payment settlement, the branded drug
maker--the plaintiff in the patent infringement
action--pays the patent challenger and alleged
infringer--the defendant--to refrain from offering its
generic drug for a period of time as part of a
settlement of patent litigation. The value in the
settlement flows in the opposite direction of what one
would ordinarily expect, where the defendant and
alleged infringer might pay the plaintiff intellectual
property (IP) rights holder for allegedly violating
those rights.\15\
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\15\In re Impax Labs., Inc., No. 9373, at 2 (F.T.C. Mar. 28, 2019).
Since 2001, the FTC has filed a number of successful
lawsuits to stop pay-for-delay settlements due to these
significant anti-competitive effects. Its efforts resulted in
the Supreme Court's 2013 landmark decision in FTC v. Actavis,
which held that these settlements are subject to antitrust
scrutiny.\16\ Following this decision, the number of these
potentially anti-competitive deals has fallen, but a
significant number have continued to occur. The total number of
such settlements filed with the FTC has dropped to 21 in FY
2014 from 29 in FY 2013, and 40 in FY 2012 prior to the Actavis
ruling.\17\ In the FTC's 2017 report assessing final Hatch-
Waxman patent settlements--the most recent report available--
the agency identified 20 final settlements that contained
explicit compensation to the generic company and a restriction
on selling a generic product for a period of time.\18\
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\16\Fed. Trade Comm'n v. Actavis, Inc., 570 U.S. 136, 158 (2013)
(holding that a ``reverse payment'' settlement agreement, ``where large
and unjustified, can bring with it the risk of significant
anticompetitive effects'').
\17\See Press Release, Fed. Trade Comm'n, FTC Report on Drug Patent
Settlements Shows Potential Pay-for-Delay Deals Decreased Substantially
in the First Year Since Supreme Court's Actavis Decision (Jan. 13,
2016), https://www.ftc.gov/news-events/press-releases/2016/01/ftc-
report-drug-patent-settlements-shows-potential-pay-delay.
\18\See Press Release, Fed. Trade Comm'n, FTC Staff Issues FY 2017
Report on Branded Drug Firms' Patent Settlements with Generic
Competitors (Dec. 3, 2020), https://www.ftc.gov/news-events/press-
releases/2020/12/ftc-staff-issues-fy-2017-report-branded-drug-firms-
patent?utm_source=govdelivery.
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NEED FOR THE LEGISLATION
H.R. 2375 is necessary to put an end to pay-for-delay
settlements. These agreements cause significant consumer harm
by imposing increased costs for prescription drugs on patients
and taxpayers. Despite the FTC's landmark victory in 2013 at
the Supreme Court in Actavis, pharmaceutical companies continue
to engage in pay-for-delay agreements. In the years since
Actavis, lawsuits challenging pay-for-delay agreements
continued to take up a large amount of the FTC's time and
resources.\19\ Furthermore, given that judges in some post-
Actavis cases appear to have misinterpreted or ignored key
aspects of the Supreme Court's decision,\20\ the ``Preserve
Access to Affordable Generics and Biosimilars Act,'' is a vital
piece of legislation to prevent backsliding by the courts that
may result in uncertainty, enforcement difficulties, or result
in a less competitive landscape altogether.
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\19\See Diagnosing the Problem: Exploring the Effects of
Consolidation and Anticompetitive Conduct in Health Care Markets:
Hearing Before the Subcomm. on Antitrust, Commercial, and Admin. Law of
the H. Comm. on the Judiciary, 116th Cong. (2019) (written testimony of
Michael Kades, Director of Markets and Competition, at 2), https://
docs.house.gov/meetings/JU/JU05/20190307/109024/HHRG-116-JU05-Bio-
KadesM-20190307.pdf.
\20\Id.; Michael A. Carrier, The Curious Case of Wellbutrin: How
the Third Circuit Mistook Itself for the Supreme Court, 103 Cornell L.
Rev. Online 137, 145 (2018) (stating that the Third Circuit's ruling in
Wellbutrin ``cannot be reconciled'' with the Supreme Court's holding in
Actavis).
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Pay-for-Delay Agreements Result in Higher Prescription Drug Costs and
Significant Harm to Patients
When pharmaceutical companies delay entry of generic or
biosimilar drugs through pay-for-delay agreements, they deprive
consumers of the lower prices that generic and biosimilar
competition brings to the market. For some consumers, these
delays could mean the difference between life and death. As a
result of soaring prices, many patients skip doses, take less
than the prescribed amount of medicine, or do not fill their
prescriptions.\21\ According to a study by Kaiser Health News,
``[h]undreds of thousands of cancer patients are delaying care,
cutting their pills in half or skipping drug treatment
entirely.''\22\
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\21\Liz Szabo, Sticker Shock Forces Thousands of Cancer Patients To
Skip Drugs, Skimp On Treatment, Kaiser Health News (Mar. 15, 2017),
https://khn.org/news/sticker-shock-forces-thousands-of-cancer-patients-
to-skip-drugs-skimp-on-treatment.
\22\Id.
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As several leading experts have noted, these delay tactics
can be enormously profitable for drug manufacturers.\23\
Michael Kades, the Director of Markets and Competition Policy
at the Washington Center for Equitable Growth, testified this
Congress that ``delaying competition on a blockbuster drug for
just a year can mean hundreds of million[s], if not billions of
dollars in additional profit.''\24\ Furthermore, in the absence
of a strong deterrent, ``many companies will see antitrust
liability simply as a cost of doing business.''\25\
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\23\See, e.g., Diagnosing the Problem: Exploring the Effects of
Consolidation and Anticompetitive Conduct in Health Care Markets:
Hearing Before the Subcomm. on Antitrust, Commercial, and Admin. Law of
the H. Comm. on the Judiciary, 116th Cong. (2019).
\24\Id. (testimony of Michael Kades, Director of Markets and
Competition Policy, Washington Center for Equitable Growth), available
at http://www.cq.com/doc/congressionaltranscripts-5482270?2; see also
In re Impax Labs., Inc., No. 9373, at 7 (F.T.C. Mar. 28, 2019) (``Endo
forecast that, if Impax launched its generic at risk, Endo would lose
85 percent of its branded Opana ER sales within three months, and $100
million in sales revenue within six months.'').
\25\Diagnosing the Problem: Exploring the Effects of Consolidation
and Anticompetitive Conduct in Health Care Markets, Hearing Before the
Subcomm. on Antitrust, Commercial, and Admin. Law of the H. Comm. on
the Judiciary, 116th Cong. (2019) (written testimony of Michael Kades,
Director of Markets and Competition Policy, Washington Center for
Equitable Growth, at 1), https://docs.house.gov/meetings/JU/JU05/
20190307/109024/HHRG-116-JU05-Bio-KadesM-20190307.pdf.
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The Supreme Court's Actavis Decision Did Not Solve the Problem
Although there has been significant progress toward
eliminating reverse payment agreements in the wake of the
Supreme Court's decision in Actavis, this ruling did not
entirely resolve the problem. As Dr. Aaron Kesselheim of
Harvard Medical School testified before the Subcommittee last
Congress:
[T]he Actavis case was really about . . . settlements
that included extremely large monetary transfers like
handing over of suitcases full of cash. But since then,
pay-for-delay settlements have continued. Many of them
also still involve monetary settlements. But many of
them also now involve more complex co-marketing
arrangements or other kinds of business deals . . . and
these kinds of agreements persist.\26\
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\26\Antitrust Concerns and the FDA Approval Process: Hearing Before
the Subcomm. on Regulatory Reform, Commercial, and Antitrust Law of the
H. Comm. on the Judiciary, 115th Cong. 32-34 (2017) (testimony of Aaron
S. Kesselheim, M.D., M.P.H., Associate Professor of Medicine, Harvard
Medical School), https://republicans-judiciary.house.gov/wp-content/
uploads/2017/07/115-27.pdf.
Lawsuits challenging pay-for-delay agreements continue to
take up a large amount of time and resources. For example, last
year marked the ten-year anniversary of when the FTC filed its
original complaint in Actavis.\27\ After over a decade,
however, the FTC announced that it reached a settlement with
the last remaining defendant.\28\ As Mr. Kades of the
Washington Center for Equitable Growth testified:
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\27\Complaint, Fed. Trade Comm'n v. Watson Pharm., Inc., No. 09-
00598 (C.D. Cal. Jan. 29, 2009), https://www.ftc.gov/sites/default/
files/documents/cases/2009/02/090202androgelcmpt_0.pdf.
\28\See Press Release, Fed. Trade Comm'n, Last Remaining Defendant
Settles FTC Suit that Led to Landmark Supreme Court Ruling on Drug
Company ``Reverse Payments'' (Feb. 28, 2019), https://www.ftc.gov/news-
events/press-releases/2019/02/last-remaining-defendant-settles-ftc-
suit-led-landmark-supreme.
Despite the U.S. Supreme Court's clear signal in the
Actavis case that pay-for-delay can be anticompetitive,
the FTC continues to spend substantial resources and
time challenging clear violations. Tougher laws, such
as the Preserve Access to Affordable Generics Act,
would deter such conduct and free up limited resources
to attack other anticompetitive conduct.\29\
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\29\Diagnosing the Problem: Exploring the Effects of Consolidation
and Anticompetitive Conduct in Health Care Markets, Hearing Before the
Subcomm. on Antitrust, Commercial, and Admin. Law of the H. Comm. on
the Judiciary, 116th Cong. (2019) (written testimony of Michael Kades,
Director of Markets and Competition Policy, Washington Center for
Equitable Growth, at 2), https://docs.house.gov/meetings/JU/JU05/
20190307/109024/HHRG-116-JU05-Bio-KadesM-20190307.pdf.
Additionally, judges in some post-Actavis cases appear to
have misinterpreted or ignored key aspects of the Supreme
Court's decision. For example, a number of commentators have
pointed out that in In re Wellbutrin XL Antitrust
Litigation,\30\ the Third Circuit departed from the Supreme
Court's reasoning in Actavis as it upheld the lower court's
dismissal of an antitrust claim based on a reverse payment
settlement.\31\ In reaching its decision, the Third Circuit
stated that it was persuaded by a defense\32\ specifically
rejected by the Supreme Court in Actavis, namely that ``risk
aversion'' could justify a branded drug company's settlement
payment to a potential generic competitor.\33\ Accordingly, the
Wellbutrin decision may invite defendants in pay-for-delay
cases to hide behind a defense the Supreme Court has already
rejected--that a large reverse payment may be justified on the
basis of the brand-name company's aversion to risk. Such
backsliding is inconsistent with the principle of stare
decisis, raises hurdles to effective enforcement, and creates
uncertainty for litigants. The ``Preserve Access to Affordable
Generics and Biosimilars Act'' is necessary to prevent courts
from backsliding. H.R. 2375 makes clear that the defenses that
the Supreme Court rejected in Actavis, including the avoidance
of risk and desire for certainty, are not available to
defendants as a justification for an otherwise illegal reverse-
payment agreement.
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\30\868 F.3d 132 (3d Cir. 2017).
\31\See, e.g., Michael A. Carrier, The Curious Case of Wellbutrin:
How the Third Circuit Mistook Itself for the Supreme Court, 103 Cornell
L. Rev. Online 137, 145 (2018) (stating that the Third Circuit's ruling
in Wellbutrin ``cannot be reconciled'' with the Supreme Court's holding
in Actavis); Br. for the Nat'l Ass'n of Chain Drug Stores, Inc. as
Amicus Curiae Supporting Appellants at 2, In re Wellbutrin XL Antitrust
Litig., 868 F.3d 132 (3d Cir. 2017) (``[T]he Panel's opinion
resuscitated the risk aversion explanation for reverse payments that
Actavis definitively rejected.'').
\32\In re Wellbutrin XL Antitrust Litig., 868 F.3d 132, 168 (3d
Cir. 2017).
\33\See Michael A. Carrier, The Curious Case of Wellbutrin: How the
Third Circuit Mistook Itself for the Supreme Court, 103 Cornell L. Rev.
Online 137, 145 (2018) (explaining that the Wellbutrin court
``resuscitated the defense based on risk aversion that the Supreme
Court had rejected'').
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H.R. 2375 Is an Effective Solution to Anti-Competitive Pay-for-Delay
Agreements
The ``Preserve Access to Affordable Generics and
Biosimilars Act'' strengthens the FTC's ability to challenge
anti-competitive pay-for-delay agreements in court. By
establishing that pay-for-delay agreements that keep lower-
priced generics from entering the market are presumptively
illegal under antitrust law, H.R. 2375 will result in lower
drug prices for consumers. This bill strikes the right balance
by deterring drug companies from reaching anti-competitive
settlements while allowing them to pursue agreements that do
not harm competition.
Hearings
In the 116th Congress, the Subcommittee on Antitrust,
Commercial, and Administrative Law held a hearing on
``Diagnosing the Problem: Exploring the Effects of
Consolidation and Anticompetitive Conduct in Health Care
Markets.''\34\ At this hearing, several witnesses testified
about competition issues in health care markets, including Dr.
Fiona Scott Morton, Professor of Economics at Yale School of
Management; Dr. Martin Gaynor, Professor of Economics and
Health Policy at Carnegie Mellon University; Michael Kades,
Director of Markets and Competition Policy at Washington Center
for Equitable Growth; and Dr. Craig Garthwaite, Herman R. Smith
Research Professor at Northwestern University's Kellogg School
of Management. At this hearing, both Dr. Scott Morton\35\ and
Mr. Kades\36\ identified pay-for-delay settlements as an
ongoing problem, and each testified about the need for
congressional action in this area. This hearing satisfies the
requirement of H. Res. 6, sec. 103(i).
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\34\Id.
\35\Id. (written testimony of Fiona Scott Morton, Professor of
Economics, Yale School of Management, at 3), https://docs.house.gov/
meetings/JU/JU05/20190307/109024/HHRG-116-JU05-Wstate-MortonF-
20190307.pdf.
\36\Id. (written testimony of Michael Kades, Director of Markets
and Competition, Washington Center for Equitable Growth, at 2), https:/
/docs.house.gov/meetings/JU/JU05/20190307/109024/HHRG-116-JU05-Bio-
KadesM-20190307.pdf.
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Last Congress, the Subcommittee held a hearing on
``Antitrust Concerns and the FDA Approval Process.''\37\ On the
first panel, the Subcommittee heard testimony from Dr. Scott
Gottlieb, Commissioner of the FDA, and Mr. Markus Meier, Acting
Director, Bureau of Competition. On the second panel, the
Subcommittee heard testimony from Professor David Olson, Boston
College Law School; Professor Erika Lietzan, University of
Missouri School of Law; Mr. Alden Abbott, Deputy Director and
Senior Legal Fellow, the Heritage Foundation; and Professor
Aaron Kesselheim, M.D. M.P.H., Harvard Medical School. During
the hearing, Acting Director Meier\38\ and Professor
Kesselheim\39\ each testified that pay-for-delay agreements
inhibit competition in health care markets and remain an
ongoing problem.
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\37\Antitrust Concerns and the FDA Approval Process: Hearing Before
the Subcomm. on Regulatory Reform, Commercial, and Antitrust Law of the
H. Comm. on the Judiciary, 115th Cong. (2017), https://republicans-
judiciary.house.gov/wp-content/uploads/2017/07/115-27.pdf.
\38\Id. at 10-11 (testimony of Markus Meier, Acting Director,
Bureau of Competition, Federal Trade Commission).
\39\Id. at 32-34 (testimony of Aaron S. Kesselheim, Associate
Professor of Medicine, Harvard Medical School).
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Committee Consideration
On April 30, 2019, the Committee met in open session and
ordered the bill, H.R. 2375, favorably reported by unanimous
voice vote, a quorum being present.
Committee Votes
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the Committee advises that no
rollcall votes occurred during the Committee's consideration of
H.R. 2375.
Committee Oversight Findings
In compliance with clause 3(c)(1) of rule XIII of the Rules
of the House of Representatives, the Committee advises that the
findings and recommendations of the Committee, based on
oversight activities under clause 2(b)(1) of rule X of the
Rules of the House of Representatives, are incorporated in the
descriptive portions of this report.
New Budget Authority and Tax Expenditures
Clause 3(c)(2) of rule XIII of the Rules of the House of
Representatives is inapplicable because this legislation does
not provide new budgetary authority or increased tax
expenditures.
Congressional Budget Office Cost Estimate
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, the Committee sets forth, with
respect to the bill, H.R. 2375, the following estimate and
comparison prepared by the Director of the Congressional Budget
Office under section 402 of the Congressional Budget Act of
1974:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
H.R. 2375 would make certain agreements--used to settle
claims of patent infringement between sponsors of brand-name,
generic, or biosimilar drugs and relating to the sale of a drug
or biological product--presumptively illegal under antitrust
law. The bill would require particular types of agreements
arising from proceedings conducted by the Patent Trial and
Appeal Board (PTAB) to be reported to Federal Trade Commission
(FTC) and the Department of Justice (DOJ). H.R. 2375 also would
establish the authority to impose civil penalties when a party
to a settlement is found to have violated the bill's
requirements.
CBO expects that the bill would accelerate the availability
of lower-priced generic or biosimilar drugs that would have
been affected by agreements targeted by the bill and reduce the
average price of drugs paid by federal health programs that
purchase drugs or provide health insurance that covers drugs.
In total, CBO estimates that enacting H.R. 2375 would decrease
the deficit by $613 million over the 2019-2029 period. That
amount includes a $520 million reduction in direct spending and
a $93 million increase in revenues.
CBO also estimates that implementing H.R. 2375 would
decrease spending subject to appropriation by $24 million over
the 2019-2024 period, assuming appropriation actions consistent
with the bill. That decrease would result primarily because
lower estimated drug prices would reduce costs for
discretionary health programs.
Details of the estimated budgetary effect of H.R 2375 are
shown in Table 1. Those effects fall primarily within budget
functions 370 (commerce and housing credit), 550 (health), and
570 (Medicare).
TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 2375
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, millions of dollars--
-------------------------------------------------------------------------------------------------------------
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2019-2024 2019-2029
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decreases in Direct Spending
Estimated Budget Authority................ 0 0 -21 -53 -63 -56 -58 -61 -65 -74 -69 -193 -520
Estimated Outlays......................... 0 0 -21 -53 -63 -56 -58 -61 -65 -74 -69 -193 -520
On-Budget............................. 0 0 -21 -53 -63 -56 -58 -61 -65 -74 -69 -192 -518
Off-Budgeta........................... 0 0 * * * * * * * * * -1 -2
Increases in Revenues
Estimated Revenues........................ 0 0 3 9 11 11 10 11 12 12 13 34 93
On-Budget............................. 0 0 3 6 8 8 7 8 9 9 10 25 69
Off-Budget............................ 0 0 1 2 3 3 3 3 3 3 3 9 24
Net Decrease in the Deficit
From Changes in Direct Spending and Revenues
Effect on the Deficit..................... 0 0 -24 -62 -74 -67 -68 -72 -77 -86 -82 -227 -613
On-Budget............................. 0 0 -23 -59 -71 -64 -66 -69 -74 -83 -78 -217 -587
Off-Budget............................ 0 0 -1 -3 -3 -3 -3 -3 -3 -3 -4 -10 -26
-------------------------------------------------------------------------------------------------------------
Increases or Decreases (-) in Spending Subject to Appropriation
Estimated Authorization................... 0 * -3 -6 -8 -7 n.e. n.e. n.e. n.e. n.e. -24 n.e.
Estimated Outlays......................... 0 * -3 -6 -8 -7 n.e. n.e. n.e. n.e. n.e. -24 n.e.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Components may not sum to totals because of rounding; n.e. = not estimated; * = between -$500,000 and zero.
aIncludes off-budget effects on the operating costs of the U.S. Postal Service.
By enhancing FTC authority to restrict certain agreements
between sponsors of brand-name, generic, or biosimilar drugs,
H.R. 2375 would impose a private-sector mandate as defined in
the Unfunded Mandates Reform Act (UMRA). The bill also would
impose a private-sector mandate by requiring those
manufacturers to notify the FTC of agreements that resolve PTAB
proceedings. CBO estimates the cost of the mandate,
particularly in the form of lost revenues, would exceed the
threshold for private-sector mandates established in UMRA ($164
million in 2019, adjusted annually for inflation) in at least
two of the first five years the mandate is in effect.
On April 26, 2019, CBO transmitted an estimate for H.R.
1499, the Protecting Consumer Access to Generic Drugs Act of
2019, as ordered reported by the House Committee on Energy and
Commerce on April 3, 2019. CBO's estimates of the effect on the
deficit through 2029 for the two bills are the same. In
different ways, both H.R. 2375 and H.R. 1499 would modify the
conduct of enforcement actions by FTC against parties to
certain agreements to settle a claim of patent infringement and
would impose significant restrictions on the terms of
compensation in affected agreements. H.R. 2375 also would
require particular types of agreements relating to PTAB
proceedings to be filed with FTC and the DOJ; H.R. 1499 does
not contain a comparable provision. CBO expects that both bills
would accelerate, on average, the availability of lower-priced
generic and biosimilar drugs to a similar extent and would
generate an equivalent amount of budgetary savings from 2020
through 2029.
The CBO staff contact for this estimate is Julia
Christensen. The estimate was reviewed by Leo Lex, Deputy
Assistant Director for Budget Analysis.
Duplication of Federal Programs
No provision of H.R. 2375 establishes or reauthorizes a
program of the Federal government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Performance Goals and Objectives
The Committee states that pursuant to clause 3(c)(4) of
rule XIII of the Rules of the House of Representatives, H.R.
2375 would lower drug prices by ending abusive pay-for-delay
settlements. By establishing that pay-for-delay agreements are
presumptively illegal under antitrust law, the ``Preserve
Access to Affordable Generics and Biosimilars Act'' will lower
drug prices for consumers.
Advisory on Earmarks
In accordance with clause 9 of rule XXI of the Rules of the
House of Representatives, H.R. 2375 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
Section-by-Section Analysis
The following discussion describes the bill as reported by
the Committee.
Section 1. Short Title. Section 1 sets forth the title of
the legislation as the ``Preserve Access to Affordable Generics
and Biosimilars Act.''
Section 2. Declaration of Purposes. Section 2 sets forth
the purposes of the Act as: (1) to enhance competition in the
pharmaceutical market by stopping anti-competitive agreements
between brand name and generic drug or biosimilar manufacturers
(and also among generic or biosimilar manufacturers) that
limit, delay, or otherwise prevent competition; and (2) to
support the purpose and intent of antitrust law by prohibiting
anti-competitive practices in the pharmaceutical industry that
harm consumers.
Section 3. Unlawful Compensation for Delay. Subsection (a)
of Section 3 amends the Federal Trade Commission (FTC) Act by
adding a new Section 27 to the FTC Act after Section 26 (15
U.S.C. Sec. 57c-2).
New subsection (a) authorizes the FTC to initiate
enforcement proceedings against the parties to an agreement
resolving or settling, on a final or interim basis, a patent
claim in connection with the sale of a drug product or
biological product. In such an action, an agreement shall be
presumed to have anti-competitive effects and be in violation
of the section if: (1) the agreement provides anything of value
to the ANDA or biosimilar biological product application filer;
and (2) the agreement includes a limitation on research,
development, manufacturing, marketing, or sales of a product
for any period of time; unless the parties can demonstrate by
clear and convincing evidence that the compensation is solely
for other goods or services the filer has promised to provide,
or the pro-competitive benefits of the agreement outweigh the
anti-competitive effects of the agreement.
New subsection (b) provides that when determining if the
parties have met the burden of the exception under subsection
(a), the fact-finder shall not presume (1) that the entry of a
product into the market would not have occurred until the
relevant patent or statutory exclusivity expires; or (2) that
the agreement for entry of a product prior to the expiration of
the relevant patent or statutory exclusivity means that the
agreement is pro-competitive.
New subsection (c) provides that nothing in this section
shall prohibit a resolution or settlement of a patent
infringement claim where the thing of value received by the
filer includes only one or more of the following: (1) the right
to market and secure final regulatory approval for a product in
the U.S. prior to the expiration of any patent that is the
basis for the patent infringement claim; or any patent right or
other statutory exclusivity that would prevent the marketing of
such ANDA product or biosimilar biological product (including
certain acceleration clauses that allow for early generic entry
and waivers of regulatory and statutory exclusivities that may
otherwise block generic entry); (2) any payment for reasonable
litigation expenses not to exceed $7,500,000 in 2019, adjusted
each year thereafter to reflect any increases in the Producer
Price Index for Legal Services; or (3) a covenant not to sue on
any claim that the ANDA product or biosimilar biological
product infringes a United States patent.
New subsection (d) provides that a violation of this
section shall be treated as an unfair method of competition
under Section 5(a)(1) of the FTC Act. A party has 30 days to
file a petition for review of the Commission's decision to a
United States Court of Appeals, but the findings of the
Commission as to the facts, if supported by evidence, shall be
conclusive.
New subsection (e) provides that nothing in this Section
shall modify, impair, limit, or supersede the antitrust laws or
the right to assert claims under the antitrust laws of any
filer of an application to approve a generic drug or a
biosimilar product.
New subsection (f) provides for penalties. A civil penalty
shall not be greater than three times the value received or
given by the parties that is reasonably attributable to
violation of this section. The Commission may recover the
penalty through a civil action in district court. In such
actions, the courts may grant mandatory injunctions and such
other and further equitable relief as the courts deem
appropriate. If the FTC issues a cease and desist order against
a party, the FTC may commence an action under this section at
any time before the expiration of one year after such order
becomes final. When determining the civil penalty amount, the
court shall take into account: (1) the nature, circumstances,
gravity, and extent of the violation; (2) the degree of
culpability, any history of violations, the ability to pay, any
effect on the ability to continue doing business, profits
earned by the parties to the agreement, compensation received
by the generic or biosimilar biological product application
filer; (3) the amount of commerce affected by the violation;
and (4) other matters that justice requires.
New subsection (g) sets forth various definitions.
Subsection (b) of Section 3 sets the effective date of the
new Section 27. That section applies to all agreements
described in section 27(a)(1) entered into on or after the date
of enactment of this Act.
Section 4. Notice and Certification of Agreements. Section
4 amends the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 by extending the definition of
``Brand Name Drug Company'' to include the owners of patents
that could be the subject of patent infringement claims arising
from the marketing of a biological product in the U.S.; and (2)
adding that an official from the company must file a
certification regarding the completeness of the materials filed
with the Assistant Attorney General and the FTC within 30 days
after the filing of any settlement agreement required to be
filed under the statute.
Section 5. Notification of Agreements. Section 5 amends the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 by clarifying that the requirement to file certain
agreements with the FTC extends to agreements resolving or
settling a Patent Trial and Appeal Board proceeding.
Section 6. Forfeiture of 180-Day Exclusivity Period.
Section 6 amends the Federal Food, Drug, and Cosmetic Act to
eliminate the 180-day exclusivity period for the first-to-file
generic drug on the market if the generic drug's manufacturer
is found to have violated new section 27 of the Federal Trade
Commission Act.
Section 7. Commission Litigation Authority. Section 7
provides the FTC exclusive authority to commence and supervise
litigation of any action or appeal under the Act, unless the
FTC authorizes the Department of Justice to do so.
Section 8. Report on Additional Exclusion. Section 8
requires the FTC to provide a recommendation to the Committee
on the Judiciary of the House of Representatives and the
Committee on the Judiciary of the Senate within one year of
enactment regarding a potential amendment to add to section
27(c) of the FTC Act an additional exclusion for consideration
granted by a branded drug company to a generic drug or
biosimilar manufacturer in the form of a release, waiver, or
limitation of a claim for damages or other monetary relief.
Section 9. Statute of Limitations. Section 9 requires the
FTC to commence an action under new section 27 of the Federal
Trade Commission Act, except for an action described in new
section 27(f)(2), no later than six years after receiving
notice of the settlement agreement under section 1112(d) of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003.
Section 10. Severability. Section 10 provides that if a
provision of this Act is held unconstitutional the remainder of
this Act will not be affected.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
FEDERAL TRADE COMMISSION ACT
* * * * * * *
Sec. 16. (a)(1) Except as otherwise provided in paragraph (2)
or (3), if--
(A) before commencing, defending, or intervening in,
any civil action involving this Act (including an
action to collect a civil penalty) which the
Commission, or the Attorney General on behalf of the
Commission, is authorized to commence, defend, or
intervene in, the Commission gives written notification
and undertakes to consult with the Attorney General
with respect to such action; and
(B) the Attorney General fails within 45 days after
receipt of such notification to commence, defend, or
intervene in, such action;
the Commission may commence, defend, or intervene in, and
supervise the litigation of, such action and any appeal of such
action in its own name by any of its attorneys designated by it
for such purpose.
(2) Except as otherwise provided in paragraph (3), in any
civil action--
(A) under section 13 of this Act (relating to
injunctive relief);
(B) under section 19 of this Act (relating to
consumer redress);
(C) to obtain judicial review of a rule prescribed by
the Commission, or a cease and desist order issued
under section 5 of this Act;
(D) under the second paragraph of section 9 of this
Act (relating to enforcement of a subpena) and under
the fourth paragraph of such section (relating to
compliance with section 6 of this Act); [or]
(E) under section 21A of this Act; or
(F) under section 27;
the Commission shall have exclusive authority to commence or
defend, and supervise the litigation of, such action and any
appeal of such action in its own name by any of its attorneys
designated by it for such purpose, unless the Commission
authorizes the Attorney General to do so. The Commission shall
inform the Attorney General of the exercise of such authority
and such exercise shall not preclude the Attorney General from
intervening on behalf of the United States in such action and
any appeal of such action as may be otherwise provided by law.
(3)(A) If the Commission makes a written request to the
Attorney General, within the 10-day period which begins on the
date of the entry of the judgment in any civil action in which
the Commission represented itself pursuant to paragraph (1) or
(2), to represent itself through any of its attorneys
designated by it for such purpose before the Supreme Court in
such action, it may do so, if--
(i) the Attorney General concurs with such request;
or
(ii) the Attorney General, within the 60-day period
which begins on the date of the entry of such
judgment--
(a) refuses to appeal or file a petition for
writ of certiorari with respect to such civil
action, in which case he shall give written
notification to the Commission of the reasons
for such refusal within such 60-day period; or
(b) the Attorney General fails to take any
action with respect to the Commission's
request.
(B) In any case where the Attorney General represents the
Commission before the Supreme Court in any civil action in
which the Commission represented itself pursuant to paragraph
(1) or (2), the Attorney General may not agree to any
settlement, compromise, or dismissal of such action, or confess
error in the Supreme Court with respect to such action, unless
the Commission concurs.
(C) For purposes of this paragraph (with respect to
representation before the Supreme Court), the term ``Attorney
General'' includes the Solicitor General.
(4) If, prior to the expiration of the 45-day period
specified in paragraph (1) of this section or a 60-day period
specified in paragraph (3), any right of the Commission to
commence, defend, or intervene in, any such action or appeal
may be extinguished due to any procedural requirement of any
court with respect to the time in which any pleadings, notice
of appeal, or other acts pertaining to such action or appeal
may be taken, the Attorney General shall have one-half of the
time required to comply with any such procedural requirement of
the court (including any extension of such time granted by the
court) for the purpose of commencing, defending, or intervening
in the civil action pursuant to paragraph (1) or for the
purpose of refusing to appeal or file a petition for writ of
certiorari and the written notification or failing to take any
action pursuant to paragraph 3(A)(ii).
(5) The provisions of this subsection shall apply
notwithstanding chapter 31 of title 28, United States Code, or
any other provision of law.
(b) Whenever the Commission has reason to believe that any
person, partnership, or corporation is liable for a criminal
penalty under this Act, the Commission shall certify the facts
to the Attorney General, whose duty it shall be to cause
appropriate criminal proceedings to be brought.
(c) Foreign Litigation.--
(1) Commission attorneys.--With the concurrence of
the Attorney General, the Commission may designate
Commission attorneys to assist the Attorney General in
connection with litigation in foreign courts on
particular matters in which the Commission has an
interest.
(2) Reimbursement for foreign counsel.--The
Commission is authorized to expend appropriated funds,
upon agreement with the Attorney General, to reimburse
the Attorney General for the retention of foreign
counsel for litigation in foreign courts and for
expenses related to litigation in foreign courts in
which the Commission has an interest.
(3) Limitation on use of funds.--Nothing in this
subsection authorizes the payment of claims or
judgments from any source other than the permanent and
indefinite appropriation authorized by section 1304 of
title 31, United States Code.
(4) Other authority.--The authority provided by this
subsection is in addition to any other authority of the
Commission or the Attorney General.
* * * * * * *
SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS AND BIOSIMILARS.
(a) In General.--
(1) Enforcement proceeding.--The Commission may
initiate a proceeding to enforce the provisions of this
section against the parties to any agreement resolving
or settling, on a final or interim basis, a patent
claim, in connection with the sale of a drug product or
biological product.
(2) Presumption and violation.--
(A) In general.--Subject to subparagraph (B),
in such a proceeding, an agreement shall be
presumed to have anticompetitive effects and
shall be a violation of this section if--
(i) an ANDA filer or a biosimilar
biological product application filer
receives anything of value, including
an exclusive license; and
(ii) the ANDA filer or biosimilar
biological product application filer
agrees to limit or forgo research,
development, manufacturing, marketing,
or sales of the ANDA product or
biosimilar biological product, as
applicable, for any period of time.
(B) Exception.--Subparagraph (A) shall not
apply if the parties to such agreement
demonstrate by clear and convincing evidence
that--
(i) the value described in
subparagraph (A)(i) is compensation
solely for other goods or services that
the ANDA filer or biosimilar biological
product application filer has promised
to provide; or
(ii) the procompetitive benefits of
the agreement outweigh the
anticompetitive effects of the
agreement.
(b) Limitations.--In determining whether the settling parties
have met their burden under subsection (a)(2)(B), the fact
finder shall not presume--
(1) that entry would not have occurred until the
expiration of the relevant patent or statutory
exclusivity; or
(2) that the agreement's provision for entry of the
ANDA product or biosimilar biological product prior to
the expiration of the relevant patent or statutory
exclusivity means that the agreement is procompetitive.
(c) Exclusions.--Nothing in this section shall prohibit a
resolution or settlement of a patent infringement claim in
which the consideration that the ANDA filer or biosimilar
biological product application filer receives as part of the
resolution or settlement includes only one or more of the
following:
(1) The right to market and secure final regulatory
approval for the ANDA product or biosimilar biological
product at a date, whether certain or contingent, in
the United States prior to the expiration of--
(A) any patent that is the basis for the
patent infringement claim; or
(B) any patent right or other statutory
exclusivity that would prevent the marketing of
such ANDA product or biosimilar biological
product.
(2) A payment for reasonable litigation expenses not
to exceed--
(A) for calendar year 2019, $7,500,000; and
(B) for calendar year 2020 and each calendar
year thereafter, the amount determined for the
preceding calendar year adjusted to reflect the
percentage increase (if any) in the Producer
Price Index for Legal Services published by the
Bureau of Labor Statistics of the Department of
Labor for the then most recent 12-month period
ending December 31.
(3) A covenant not to sue on any claim that the ANDA
product or biosimilar biological product infringes a
United States patent.
(d) Enforcement.--
(1) Enforcement.--A violation of this section shall
be treated as an unfair method of competition under
section 5(a)(1) of the Federal Trade Commission Act (15
U.S.C. 45(a)(1)).
(2) Judicial review.--
(A) In general.--Any party that is subject to
a final order of the Commission, issued in an
administrative adjudicative proceeding under
the authority of subsection (a)(1), may, within
30 days of the issuance of such order, petition
for review of such order 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
successor thereto, of the NDA holder or
biological product license holder is
incorporated as of the date that the
NDA or biological product license
application, as applicable, is filed
with the Commissioner of Food and
Drugs; or
(iii) the United States Court of
Appeals for the circuit in which the
ultimate parent entity of the ANDA
filer or biosimilar biological product
application filer is incorporated as of
the date that the ANDA or biosimilar
biological product application is filed
with the Commissioner of Food and
Drugs.
(B) Treatment of findings.--In a proceeding
for judicial review of a final order of the
Commission, the findings of the Commission as
to the facts, if supported by evidence, shall
be conclusive.
(e) Antitrust Laws.--Nothing in this section shall modify,
impair, limit, or supersede the applicability of the antitrust
laws as defined in subsection (a) of the first section of the
Clayton Act (15 U.S.C. 12(a)), and of section 5 of this Act to
the extent that section 5 applies to unfair methods of
competition. Nothing in this section shall modify, impair,
limit, or supersede the right of an ANDA filer or biosimilar
biological product application filer to assert claims or
counterclaims against any person, under the antitrust laws or
other laws relating to unfair competition.
(f) Penalties.--
(1) Forfeiture.--Each party that violates or assists
in the violation of this section shall forfeit and pay
to the United States a civil penalty sufficient to
deter violations of this section, but in no event
greater than 3 times the value received by the party
that is reasonably attributable to the violation of
this section. If no such value has been received by the
NDA holder, biological product license holder, the ANDA
filer, or biosimilar biological product application
filer the penalty to the NDA holder, biological product
license holder, the ANDA filer, or biosimilar
biological product application filer shall be
sufficient to deter violations, but in no event greater
than 3 times the value given to an ANDA filer or
biosimilar biological product application filer
reasonably attributable to the violation of this
section. Such penalty shall accrue to the United States
and may be recovered in a civil action brought by the
Commission, in its own name by any of its attorneys
designated by it for such purpose, in a district court
of the United States against any party that violates
this section. In such actions, the United States
district courts are empowered to grant mandatory
injunctions and such other and further equitable relief
as they deem appropriate.
(2) Cease and desist.--
(A) In general.--If the Commission has issued
a cease and desist order with respect to a
party in an administrative adjudicative
proceeding under the authority of subsection
(a)(1), an action brought pursuant to paragraph
(1) may be commenced against such party at any
time before the expiration of 1 year after such
order becomes final pursuant to section 5(g).
(B) Exception.--In an action under
subparagraph (A), the findings of the
Commission as to the material facts in the
administrative adjudicative proceeding with
respect to the violation of this section by a
party shall be conclusive unless--
(i) the terms of such cease and
desist order expressly provide that the
Commission's findings shall not be
conclusive; or
(ii) the order became final by reason
of section 5(g)(1), in which case such
finding shall be conclusive if
supported by evidence.
(3) Civil penalty.--In determining the amount of the
civil penalty described in this section, the court
shall take into account--
(A) the nature, circumstances, extent, and
gravity of the violation;
(B) with respect to the violator, the degree
of culpability, any history of violations, the
ability to pay, any effect on the ability to
continue doing business, profits earned by the
NDA holder, biological product license holder,
the ANDA filer, or biosimilar biological
product application filer, compensation
received by the ANDA filer or biosimilar
biological product application filer, and the
amount of commerce affected; and
(C) other matters that justice requires.
(4) Remedies in addition.--Remedies provided in this
subsection are in addition to, and not in lieu of, any
other remedy provided by Federal law. Nothing in this
paragraph shall be construed to affect any authority of
the Commission under any other provision of law.
(g) Definitions.--In this section:
(1) Agreement.--The term ``agreement'' means anything
that would constitute an agreement under section 1 of
the Sherman Act (15 U.S.C. 1) or section 5 of this Act.
(2) Agreement resolving or settling a patent
infringement claim.--The term ``agreement resolving or
settling a patent infringement claim'' includes any
agreement that is entered into within 30 days of the
resolution or the settlement of the claim, or any other
agreement that is contingent upon, provides a
contingent condition for, or is otherwise related to
the resolution or settlement of the claim.
(3) ANDA.--The term ``ANDA'' means an abbreviated new
drug application filed under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
or a new drug application filed under section 505(b)(2)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)(2)).
(4) ANDA filer.--The term ``ANDA filer'' means a
party that owns or controls an ANDA filed with the Food
and Drug Administration or has the exclusive rights
under such ANDA to distribute the ANDA product.
(5) ANDA product.--The term ``ANDA product'' means
the product to be manufactured under the ANDA that is
the subject of the patent infringement claim.
(6) Biological product.--The term ``biological
product'' has the meaning given such term in section
351(i)(1) of the Public Health Service Act (42 U.S.C.
262(i)(1)).
(7) Biological product license application.--The term
``biological product license application'' means an
application under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)).
(8) Biological product license holder.--The term
``biological product license holder'' means--
(A) the holder of an approved biological
product license application for a biological
product;
(B) a person owning or controlling
enforcement of any patents that claim the
biological product that is the subject of such
approved application; or
(C) the predecessors, subsidiaries,
divisions, groups, and affiliates controlled
by, controlling, or under common control with
any of the entities described in subparagraphs
(A) and (B) (such control to be presumed by
direct or indirect share ownership of 50
percent or greater), as well as the licensees,
licensors, successors, and assigns of each of
the entities.
(9) Biosimilar biological product.--The term
``biosimilar biological product'' means the product to
be manufactured under the biosimilar biological product
application that is the subject of the patent
infringement claim.
(10) Biosimilar biological product application.--The
term ``biosimilar biological product application''
means an application under section 351(k) of the Public
Health Service Act (42 U.S.C. 262(k)) for licensure of
a biological product as biosimilar to, or
interchangeable with, a reference product.
(11) Biosimilar biological product application
filer.--The term ``biosimilar biological product
application filer'' means a party that owns or controls
a biosimilar biological product application filed with
the Food and Drug Administration or has the exclusive
rights under such application to distribute the
biosimilar biological product.
(12) Drug product.--The term ``drug product'' has the
meaning given such term in section 314.3(b) of title
21, Code of Federal Regulations (or any successor
regulation).
(13) Market.--The term ``market'' means the promote,
offer for sale, sell, or distribute a drug product.
(14) NDA.--The term ``NDA'' means a new drug
application filed under section 505(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).
(15) NDA holder.--The term ``NDA holder'' means--
(A) the holder of an approved NDA application
for a drug product;
(B) a person owning or controlling
enforcement of the patent listed in the
Approved Drug Products With Therapeutic
Equivalence Evaluations (commonly known as the
``FDA Orange Book'') in connection with the
NDA; or
(C) the predecessors, subsidiaries,
divisions, groups, and affiliates controlled
by, controlling, or under common control with
any of the entities described in subparagraphs
(A) and (B) (such control to be presumed by
direct or indirect share ownership of 50
percent or greater), as well as the licensees,
licensors, successors, and assigns of each of
the entities.
(16) Party.--The term ``party'' means any person,
partnership, corporation, or other legal entity.
(17) Patent infringement.--The term ``patent
infringement'' means infringement of any patent or of
any filed patent application, including any extension,
reissue, renewal, division, continuation, continuation
in part, reexamination, patent term restoration,
patents of addition, and extensions thereof.
(18) Patent infringement claim.--The term ``patent
infringement claim'' means any allegation made to an
ANDA filer or biosimilar biological product application
filer, whether or not included in a complaint filed
with a court of law, that its ANDA or ANDA product, or
biological product license application or biological
product, may infringe any patent held by, or
exclusively licensed to, the NDA holder or biological
product license holder, biological product license
holder, the ANDA filer, or biosimilar biological
product application filer of the drug product or
biological product, as applicable.
(19) Statutory exclusivity.--The term ``statutory
exclusivity'' means those prohibitions on the approval
of drug applications under clauses (ii) through (iv) of
section 505(c)(3)(E) (5- and 3-year data exclusivity),
section 527 (orphan drug exclusivity), or section 505A
(pediatric exclusivity) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)(3)(E), 360cc, 355a), or
on the licensing of biological product applications
under section 351(k)(7) (12-year exclusivity) or
paragraph (2) or (3) of section 351(m) (pediatric
exclusivity) of the Public Health Service Act (42
U.S.C. 262) or under section 527 of the Federal Food,
Drug, and Cosmetic Act (orphan drug exclusivity).
* * * * * * *
----------
MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION ACT OF 2003
* * * * * * *
TITLE XI--ACCESS TO AFFORDABLE PHARMACEUTICALS
* * * * * * *
Subtitle B--Federal Trade Commission Review
SEC. 1111. DEFINITIONS.
In this subtitle:
(1) ANDA.--The term ``ANDA'' means an abbreviated
drug application, as defined under section 201(aa) of
the Federal Food, Drug, and Cosmetic Act.
(2) Assistant attorney general.--The term ``Assistant
Attorney General'' means the Assistant Attorney General
in charge of the Antitrust Division of the Department
of Justice.
(3) Biosimilar biological product.--The term
``biosimilar biological product'' means a biological
product for which a biosimilar biological product
application under section 351(k) of the Public Health
Service Act is approved.
(4) Biosimilar biological product applicant.--The
term ``biosimilar biological product applicant'' means
a person who has filed or received approval for a
biosimilar biological product application under section
351(k) of the Public Health Service Act.
(5) Biosimilar biological product application.--The
term ``biosimilar biological product application''
means an application under section 351(k) of the Public
Health Service Act for licensure of a biological
product as biosimilar to, or interchangeable with, a
reference product.
(6) Brand name drug.--The term ``brand name drug''
means a drug for which an application is approved under
section 505(c) of the Federal Food, Drug, and Cosmetic
Act, including an application referred to in section
505(b)(2) of such Act, or a biological product for
which an application is approved under section 351(a)
of the Public Health Service Act.
(7) Brand name drug company.--The term ``brand name
drug company'' means the party that holds the approved
application referred to in paragraph (6) for a brand
name drug that is a listed drug in an ANDA or a
reference product in a biosimilar biological product
application, or a party that is the owner of a patent
for which information is submitted for such drug under
subsection (b) or (c) of section 505 of the Federal
Food, Drug, and Cosmetic Act or the owner, or exclusive
licensee, of a patent included in a list provided under
section 351(l)(3) of the Public Health Service Act or
the owner of a patent for which a claim of infringement
could reasonably be asserted against any person for
making, using, offering to sell, selling, or importing
into the United States a biological product that is the
subject of a biosimilar biological product application.
(8) Commission.--The term ``Commission'' means the
Federal Trade Commission.
(9) Generic drug.--The term ``generic drug'' means a
drug for which an application under section 505(j) of
the Federal Food, Drug, and Cosmetic Act is approved.
(10) Generic drug applicant.--The term ``generic drug
applicant'' means a person who has filed or received
approval for an ANDA under section 505(j) of the
Federal Food, Drug, and Cosmetic Act.
(11) Listed drug.--The term ``listed drug'' means a
brand name drug that is listed under section 505(j)(7)
of the Federal Food, Drug, and Cosmetic Act.
(12) Reference product.--The term ``reference
product''has the meaning given such term in section
351(i) of the Public Health Service Act.
SEC. 1112. NOTIFICATION OF AGREEMENTS.
(a) Agreement With Brand Name Drug Company.--
(1) Requirement.--A generic drug applicant that has
submitted an ANDA containing a certification under
section 505(j)(2)(A)(vii)(IV) of the Federal Food,
Drug, and Cosmetic Act or a biosimilar biological
product applicant who has submitted a biosimilar
biological product application and a brand name drug
company that enter into an agreement described in
paragraph (2) shall each file the agreement in
accordance with subsection (c). The agreement shall be
filed prior to the date of the first commercial
marketing of the generic drug that is the subject of
the ANDA or the biosimilar biological product that is
the subject of the biosimilar biological product
application, as applicable.
(2) Subject matter of agreement.--An agreement
described in this paragraph between a generic drug
applicant or a biosimilar biological product applicant
and a brand name drug company is an agreement
regarding--
(A) the manufacture, marketing, or sale of
the brand name drug that is the listed drug in
the ANDA or the reference product in the
biosimilar biological product application
involved;
(B) the manufacture, marketing, or sale of
the generic drug for which the ANDA was
submitted or of the biosimilar biological
product for which the biosimilar biological
product application was submitted; or
(C) as applicable--
(i) the 180-day period referred to in
section 505(j)(5)(B)(iv) of the Federal
Food, Drug, and Cosmetic Act as it
applies to such ANDA or to any other
ANDA based on the same listed drug; or
(ii) any of the time periods referred
to in section 351(k)(6) of the Public
Health Service Act as such period
applies to such biosimilar biological
product application or to any other
biosimilar biological product
application based on the same reference
product.
(b) Agreement With Another Generic Drug Applicant Or
Biosimilar Biological Product Applicant.--
(1) Requirement.--
(A) Generic drugs.--A generic drug applicant
that has submitted an ANDA containing a
certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food,
Drug, and Cosmetic Act with respect to a listed
drug and another generic drug applicant that
has submitted an ANDA containing such a
certification for the same listed drug shall
each file the agreement in accordance with
subsection (c). The agreement shall be filed
prior to the date of the first commercial
marketing of either of the generic drugs for
which such ANDAs were submitted.
(B) Biosimilar biological products.--A
biosimilar biological product applicant that
has submitted a biosimilar biological product
application that references a reference product
and another biosimilar biological product
applicant that has submitted a biosimilar
biological product application that references
the same reference product shall each file the
agreement in accordance with subsection (c).
The agreement shall be filed prior to the date
of the first commercial marketing of either of
the biosimilar biological products for which
such biosimilar biological product applications
were submitted.
(2) Subject matter of agreement.--An agreement
described in this paragraph is, as applicable, an
agreement between 2 or more generic drug applicants
regarding the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and
Cosmetic Act as it applies to the ANDAs with which the
agreement is concerned,, an agreement between 2 or more
biosimilar biological product applicants regarding a
time period referred to in section 351(k)(6) of the
Public Health Service Act as it applies to the
biosimilar biological product, or an agreement between
2 or more biosimilar biological product applicants
regarding the manufacture, marketing, or sale of a
biosimilar biological product.
(c) Filing.--
(1) Agreement.--The parties that are required in
subsection (a) or (b) to file an agreement in
accordance with this subsection shall file with the
Assistant Attorney General and the Commission the text
of any such agreement, except that such parties are not
required to file an agreement that solely concerns--
(A) purchase orders for raw material
supplies;
(B) equipment and facility contracts;
(C) employment or consulting contracts; or
(D) packaging and labeling contracts.
(2) Other agreements.--The parties that are required
in subsection (a) or (b) to file an agreement in
accordance with this subsection shall file with the
Assistant Attorney General and the Commission the text
of any agreements between the parties that are not
described in such subsections and are contingent upon,
provide a contingent condition for, were entered into
within 30 days of, or are otherwise related to an
agreement that is required in subsection (a) or (b) to
be filed in accordance with this subsection.
(3) Description.--In the event that any agreement
required in subsection (a) or (b) to be filed in
accordance with this subsection has not been reduced to
text, each of the parties involved shall file written
descriptions of such agreement that are sufficient to
disclose all the terms and conditions of the agreement.
(d) Certification.--The Chief Executive Officer or the
company official responsible for negotiating any agreement
under subsection (a) or (b) that is required to be filed under
subsection (c), within 30 days after such filing, shall execute
and file with the Assistant Attorney General and the Commission
a certification as follows: ``I declare that the following is
true, correct, and complete to the best of my knowledge: The
materials filed with the Federal Trade Commission and the
Department of Justice under section 1112 of subtitle B of title
XI of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, with respect to the agreement
referenced in this certification--
``(1) represent the complete, final, and exclusive
agreement between the parties;
``(2) include any ancillary agreements that are
contingent upon, provide a contingent condition for, or
are otherwise related to, the referenced agreement; and
``(3) include written descriptions of any oral
agreements, representations, commitments, or promises
between the parties that are responsive to subsection
(a) or (b) of such section 1112 and have not been
reduced to writing.''.
(4) Rule of construction.--
(A) An agreement that is required in
subsection (a) or (b) shall include agreements
resolving any outstanding disputes, including
agreements resolving or settling a Patent Trial
and Appeal Board proceeding.
(B) For purposes of subparagraph (A), the
term ``Patent Trial and Appeal Board
proceeding'' means a proceeding conducted by
the United States Patent and Trademark Office
Patent Trial and Appeal Board, including but
not limited to inter parties review, post-grant
review, the transitional program for covered
business method patents, and derivation
proceedings.
* * * * * * *
----------
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
new drugs
Sec. 505. (a) No person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an
approval of an application filed pursuant to subsection (b) or
(j) is effective with respect to such drug.
(b)(1) Any person may file with the Secretary an application
with respect to any drug subject to the provisions of
subsection (a). Such persons shall submit to the Secretary as a
part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe
for use and whether such drug is effective in use; (B) a full
list of the articles used as components of such drug; (C) a
full statement of the composition of such drug; (D) a full
description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of
such drug; (E) such samples of such drug and of the articles
used as components thereof as the Secretary may require; (F)
specimens of the labeling proposed to be used for such drug,
and (G) any assessments required under section 505B. The
applicant shall file with the application the patent number and
the expiration date of any patent which claims the drug for
which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture use, or
sale of the drug. If a application is filed under this
subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the
Secretary shall publish information submitted under the two
preceding sentences. The Secretary shall, in consultation with
the Director of the National Institutes of Health and with
representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).
(2) An application submitted under paragraph (1) for a drug
for which the investigations described in clause (A) of such
paragraph and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted shall also include--
(A) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the drug for which such
investigations were conducted or which claims a use for
such drug for which the applicant is seeking approval
under this subsection and for which information is
required to be filed under paragraph (1) or subsection
(c)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which
investigations described in paragraph (1)(A) were
conducted information was filed under paragraph (1) or
subsection (c) for a method of use patent which does
not claim a use for which the applicant is seeking
approval under this subsection, a statement that the
method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that
makes a certification described in paragraph (2)(A)(iv)
shall include in the application a statement that the
applicant will give notice as required by this
paragraph.
(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall
give notice as required under this paragraph--
(i) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(ii) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(C) Recipients of notice.--An applicant required
under this paragraph to give notice shall give notice
to--
(i) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application
under this subsection for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(D) Contents of notice.--A notice required under this
paragraph shall--
(i) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(ii) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(4)(A) An applicant may not amend or supplement an
application referred to in paragraph (2) to seek approval of a
drug that is a different drug than the drug identified in the
application as submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3)
prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1) or under
section 351 of the Public Health Service Act, which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size--
(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or
(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated
clinical trials which, in combination, are intended to
form the primary basis of an effectiveness claim; or
(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public
Health Service Act, of any necessary clinical study or
studies.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the
clinical trials. Minutes of any such meeting shall be prepared
by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and
size of clinical trials of a new drug under this paragraph that
is reached between the Secretary and a sponsor or applicant
shall be reduced to writing and made part of the administrative
record by the Secretary. Such agreement shall not be changed
after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection or section 351 of the
Public Health Service Act (including all scientific and medical
matters, chemistry, manufacturing, and controls).
(6) An application submitted under this subsection
shall be accompanied by the certification required
under section 402(j)(5)(B) of the Public Health Service
Act. Such certification shall not be considered an
element of such application.
(c)(1) Within one hundred and eighty days after the filing of
an application under subsection (b), or such additional period
as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that
none of the grounds for denying approval specified in
subsection (d) applies, or
(B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) on
the question whether such application is approvable. If
the applicant elects to accept the opportunity for
hearing by written request within thirty days after
such notice, such hearing shall commence not more than
ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an
expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by
the Secretary for filing final briefs.
(2) If the patent information described in subsection (b)
could not be filed with the submission of an application under
subsection (b) because the application was filed before the
patent information was required under subsection (b) or a
patent was issued after the application was approved under such
subsection, the holder of an approved application shall file
with the Secretary, the patent number and the expiration date
of any patent which claims the drug for which the application
was submitted or which claims a method of using such drug and
with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug. If the
holder of an approved application could not file patent
information under subsection (b) because it was not required at
the time the application was approved, the holder shall file
such information under this subsection not later than thirty
days after the date of the enactment of this sentence, and if
the holder of an approved application could not file patent
information under subsection (b) because no patent had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than thirty days after after the date the patent involved is
issued. Upon the submission of patent information under this
subsection, the Secretary shall publish it.
(3) The approval of an application filed under subsection (b)
which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable
date determined by applying the following to each certification
made under subsection (b)(2)(A):
(A) If the applicant only made a certification
described in clause (i) or (ii) of subsection (b)(2)(A)
or in both such clauses, the approval may be made
effective immediately.
(B) If the applicant made a certification described
in clause (iii) of subsection (b)(2)(A), the approval
may be made effective on the date certified under
clause (iii).
(C) If the applicant made a certification described
in clause (iv) of subsection (b)(2)(A), the approval
shall be made effective immediately unless, before the
expiration of 45 days after the date on which the
notice described in subsection (b)(3) is received, an
action is brought for infringement of the patent that
is the subject of the certification and for which
information was submitted to the Secretary under
paragraph (2) or subsection (b)(1) before the date on
which the application (excluding an amendment or
supplement to the application) was submitted. If such
an action is brought before the expiration of such
days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under
subsection (b)(3) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(i) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(I) the date on which the court
enters judgment reflecting the
decision; or
(II) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(ii) if before the expiration of such period
the district court decides that the patent has
been infringed--
(I) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(aa) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(bb) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(II) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(iii) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in clause (ii).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
referred to in subsection (b)(2) for a
declaratory judgment with respect to a
patent which is the subject of the
certification referred to in
subparagraph (C) unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant referred to in subsection
(b)(2) for the purpose of determining
whether an action referred to in
subparagraph (C) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under subsection
(b)(2)(A)(iv) and for no other purpose,
and may not disclose information of no
relevance to any issue of patent
infringement to any person other than a
person provided an offer of
confidential access. Further, the
application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or this subsection
on the ground that the patent does not
claim either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(E)(i) If an application (other than an abbreviated
new drug application) submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
subsection, the Secretary may not make the approval of
another application for a drug for which the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and for which the applicant has not obtained
a right of reference or use from the person by or for
whom the investigations were conducted effective before
the expiration of ten years from the date of the
approval of the application previously approved under
subsection (b).
(ii) If an application submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
is approved after the date of the enactment of this
clause, no application which refers to the drug for
which the subsection (b) application was submitted and
for which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted may be
submitted under subsection (b) before the expiration of
five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under subsection (b) after
the expiration of four years from the date of the
approval of the subsection (b) application if it
contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection
(b)(2)(A). The approval of such an application shall be
made effective in accordance with this paragraph except
that, if an action for patent infringement is commenced
during the one-year period beginning forty-eight months
after the date of the approval of the subsection (b)
application, the thirty-month period referred to in
subparagraph (C) shall be extended by such amount of
time (if any) which is required for seven and one-half
years to have elapsed from the date of approval of the
subsection (b) application.
(iii) If an application submitted under subsection
(b) for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient)
that has been approved in another application approved
under subsection (b), is approved after the date of the
enactment of this clause and if such application
contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of
an application submitted under subsection (b) for the
conditions of approval of such drug in the approved
subsection (b) application effective before the
expiration of three years from the date of the approval
of the application under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of
new clinical investigations (other than bioavailabilty
studies) essential to the approval of the supplement
and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of
an application submitted under subsection (b) for a
change approved in the supplement effective before the
expiration of three years from the date of the approval
of the supplement under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an
application) submitted under subsection (b) for a drug,
which includes an active ingredient (including any
ester or salt of the active ingredient) that has been
approved in another application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
clause, the Secretary may not make the approval of an
application submitted under this subsection and for
which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted and which
refers to the drug for which the subsection (b)
application was submitted effective before the
expiration of two years from the date of enactment of
this clause.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(5)(A) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with
respect to a qualified indication for a drug, submitted under
subsection (b), if such supplemental application complies with
subparagraph (B).
(B) A supplemental application is eligible for review as
described in subparagraph (A) only if--
(i) there is existing data available and acceptable
to the Secretary demonstrating the safety of the drug;
and
(ii) all data used to develop the qualified data
summaries are submitted to the Secretary as part of the
supplemental application.
(C) The Secretary shall post on the Internet website of the
Food and Drug Administration and update annually--
(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(iii) the average time for review of supplemental
applications where the Secretary did not use review
flexibility under subparagraph (A) or section
351(a)(2)(E) of the Public Health Service Act; and
(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act for which the Secretary made use of
full data sets in addition to the qualified data
summary.
(D) In this paragraph--
(i) the term ``qualified indication'' means an
indication for a drug that the Secretary determines to
be appropriate for summary level review under this
paragraph; and
(ii) the term ``qualified data summary'' means a
summary of clinical data that demonstrates the safety
and effectiveness of a drug with respect to a qualified
indication.
(d) If the Secretary finds, after due notice to the applicant
in accordance with subsection (c) and giving him an opportunity
for a hearing, in accordance with said subsection, that (1) the
investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b), do not include
adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions; (3) the methods
used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity; (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe
for use under such conditions; or (5) evaluated on the basis of
the information submitted to him as part of the application and
any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall
issue an order refusing to approve the application. If, after
such notice and opportunity for hearing, the Secretary finds
that clauses (1) through (6) do not apply, he shall issue an
order approving the application. As used in this subsection and
subsection (e), the term ``substantial evidence'' means
evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
The Secretary shall implement a structured risk-benefit
assessment framework in the new drug approval process to
facilitate the balanced consideration of benefits and risks, a
consistent and systematic approach to the discussion and
regulatory decisionmaking, and the communication of the
benefits and risks of new drugs. Nothing in the preceding
sentence shall alter the criteria for evaluating an application
for marketing approval of a drug.
(e) The Secretary shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of an application
with respect to any drug under this section if the Secretary
finds (1) that clinical or other experience, tests, or other
scientific data show that such drug is unsafe for use under the
conditions of use upon the basis of which the application was
approved; (2) that new evidence of clinical experience, not
contained in such application or not available to the Secretary
until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was approved, evaluated together with the
evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the
application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the
application was approved, that there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof; or (4) the
patent information prescribed by subsection (c) was not filed
within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
(5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his
absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the
approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant
the opportunity for an expedited hearing under this subsection;
but the authority conferred by this proviso to suspend the
approval of an application shall not be delegated. The
Secretary may also, after due notice and opportunity for
hearing to the applicant, withdraw the approval of an
application submitted under subsection (b) or (j) with respect
to any drug under this section if the Secretary finds (1) that
the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in
accordance with a regulation or order under subsection (k) or
to comply with the notice requirements of section 510(k)(2), or
the applicant has refused to permit access to, or copying or
verification of, such records as required by paragraph (2) of
such subsection; or (2) that on the basis of new information
before him, evaluated together with the evidence before him
when the application was approved, the methods used in, or the
facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve
its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a
fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based. The
Secretary may withdraw the approval of an application submitted
under this section, or suspend the approval of such an
application, as provided under this subsection, without first
ordering the applicant to submit an assessment of the approved
risk evaluation and mitigation strategy for the drug under
section 505-1(g)(2)(D).
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d) or (e)
refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval,
as may be appropriate.
(g) Orders of the Secretary issued under this section shall
be served (1) in person by any officer or employee of the
Department designated by the Secretary or (2) by mailing the
order by registered mail or by certified mail addressed to the
applicant or respondent at his last-known address in the
records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application under this section. Such appeal shall be taken by
filing in the United States court of appeals for the circuit
wherein such applicant resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the
Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court
the record upon which the order complained of was entered, as
provided in section 2112 of title 28, United States Code. Upon
the filing of such petition such court shall have exclusive
jurisdiction to affirm or set aside such order, except that
until the filing of the record the Secretary may modify or set
aside his order. No objection to the order of the Secretary
shall be considered by the court unless such objection shall
have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show
to the satisfaction of the court that such additional evidence
is material and that there were reasonable grounds for failure
to adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence to be taken before
the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts
by reason of the additional evidence so taken, and he shall
file with the court such modified findings which, if supported
by substantial evidence, shall be conclusive, and his
recommendation, if any, for the setting aside of the original
order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court
to the contrary, operate as a stay of the Secretary's order.
(i)(1) The Secretary shall promulgate regulations for
exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, within the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any
clinical testing of a new drug is undertaken, of
reports, by the manufacturer or the sponsor of the
investigation of such drug, or preclinical tests
(including tests on animals) of such drug adequate to
justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed
to investigators for clinical testing obtaining a
signed agreement from each of such investigators that
patients to whom the drug is administered will be under
his personal supervision, or under the supervision of
investigators responsible to him, and that he will not
supply such drug to any other investigator, or to
clinics, for administration to human beings;
(C) the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not
limited to analytical reports by investigators)
obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such drug in
the event of the filing of an application pursuant to
subsection (b); and
(D) the submission to the Secretary by the
manufacturer or the sponsor of the
investigation of a new drug of a statement of
intent regarding whether the manufacturer or
sponsor has plans for assessing pediatric
safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a
new drug may begin 30 days after the Secretary has received
from the manufacturer or sponsor of the investigation a
submission containing such information about the drug and the
clinical investigation, including--
(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess
the safety of the drug for use in clinical
investigation; and
(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the
drug, and primary data tabulations from animal or human
studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is that--
(i) the drug involved represents an unreasonable risk
to the safety of the persons who are the subjects of
the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the drug, the design of the clinical
investigation, the condition for which the drug is to
be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish (including reasons established by regulation
before the date of the enactment of the Food and Drug
Administration Modernization Act of 1997).
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer
or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except
where it is not feasible, it is contrary to the best interests
of such human beings, or the proposed clinical testing poses no
more than minimal risk to such human beings and includes
appropriate safeguards as prescribed to protect the rights,
safety, and welfare of such human beings. Nothing in this
subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the
investigational use of drugs. The Secretary shall update such
regulations to require inclusion in the informed consent
documents and process a statement that clinical trial
information for such clinical investigation has been or will be
submitted for inclusion in the registry data bank pursuant to
subsection (j) of section 402 of the Public Health Service Act.
(j)(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall
contain--
(i) information to show that the conditions of use
prescribed, recommended, or suggested in the labeling
proposed for the new drug have been previously approved
for a drug listed under paragraph (7) (hereinafter in
this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i)
has only one active ingredient, information to show
that the active ingredient of the new drug is the same
as that of the listed drug;
(II) if the listed drug referred to in clause (i) has
more than one active ingredient, information to show
that the active ingredients of the new drug are the
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i)
has more than one active ingredient and if one of the
active ingredients of the new drug is different and the
application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug
are the same as the active ingredients of the listed
drug, information to show that the different active
ingredient is an active ingredient of a listed drug or
of a drug which does not meet the requirements of
section 201(p), and such other information respecting
the different active ingredient with respect to which
the petition was filed as the Secretary may require;
(iii) information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the
new drug is different and the application is filed
pursuant to the approval of a petition filed under
subparagraph (C), such information respecting the route
of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is
bioequivalent to the listed drug referred to in clause
(i), except that if the application is filed pursuant
to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of
the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred
to in clause (i) and the new drug can be expected to
have the same therapeutic effect as the listed drug
when administered to patients for a condition of use
referred to in clause (i);
(v) information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to in clause (i) except
for changes required because of differences approved
under a petition filed under subparagraph (C) or
because the new drug and the listed drug are produced
or distributed by different manufacturers;
(vi) the items specified in clauses (B) through (F)
of subsection (b)(1);
(vii) a certification, in the opinion of the
applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug
referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking
approval under this subsection and for which
information is required to be filed under subsection
(b) or (c)--
(I) that such patent information has not been
filed,
(II) that such patent has expired,
(III) of the date on which such patent will
expire, or
(IV) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to
in clause (i) information was filed under subsection
(b) or (c) for a method of use patent which does not
claim a use for which the applicant is seeking approval
under this subsection, a statement that the method of
use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that
makes a certification described in subparagraph
(A)(vii)(IV) shall include in the application a
statement that the applicant will give notice as
required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV)
shall give notice as required under this subparagraph--
(I) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(II) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(iii) Recipients of notice.--An applicant required
under this subparagraph to give notice shall give
notice to--
(I) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(iv) Contents of notice.--A notice required under
this subparagraph shall--
(I) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(II) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(C) If a person wants to submit an abbreviated application
for a new drug which has a different active ingredient or whose
route of administration, dosage form, or strength differ from
that of a listed drug, such person shall submit a petition to
the Secretary seeking permission to file such an application.
The Secretary shall approve or disapprove a petition submitted
under this subparagraph within ninety days of the date the
petition is submitted. The Secretary shall approve such a
petition unless the Secretary finds--
(i) that investigations must be conducted to show the
safety and effectiveness of the drug or of any of its
active ingredients, the route of administration, the
dosage form, or strength which differ from the listed
drug; or
(ii) that any drug with a different active ingredient
may not be adequately evaluated for approval as safe
and effective on the basis of the information required
to be submitted in an abbreviated application.
(D)(i) An applicant may not amend or supplement an
application to seek approval of a drug referring to a different
listed drug from the listed drug identified in the application
as submitted to the Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant
from amending or supplementing the application to seek approval
of a different strength.
(iii) Within 60 days after the date of the enactment of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, the Secretary shall issue guidance defining the term
``listed drug'' for purposes of this subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1), which
shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection if the sponsor or applicant makes a reasonable
written request for a meeting for the purpose of reaching
agreement on the design and size of bioavailability and
bioequivalence studies needed for approval of such application.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size
of bioavailability and bioequivalence studies of a drug under
this paragraph that is reached between the Secretary and a
sponsor or applicant shall be reduced to writing and made part
of the administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection (including scientific
matters, chemistry, manufacturing, and controls).
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(B) information submitted with the application is
insufficient show that each of the proposed conditions
of use have been previously approved for the listed
drug referred to in the application;
(C)(i) if the listed drug has only one active
ingredient, information submitted with the application
is insufficient to show that the active ingredient is
the same as that of the listed drug;
(ii) if the listed drug has more than one active
ingredient, information submitted with the application
is insufficient to show that the active ingredients are
the same as the active ingredients of the listed drug,
or
(iii) if the listed drug has more than one active
ingredient and if the application is for a drug which
has an active ingredient different from the listed
drug, information submitted with the application is
insufficient to show--
(I) that the other active ingredients are the
same as the active ingredients of the listed
drug, or
(II) that the different active ingredient is
an active ingredient of a listed drug or a drug
which does not meet the requirements of section
201(p),
or no petition to file an application for the drug with
the different ingredient was approved under paragraph
(2)(C);
(D)(i) if the application is for a drug whose route
of administration, dosage form, or strength of the drug
is the same as the route of administration, dosage
form, or strength of the listed drug referred to in the
application, information submitted in the application
is insufficient to show that the route of
administration, dosage form, or strength is the same as
that of the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is
different from that of the listed drug referred to in
the application, no petition to file an application for
the drug with the different route of administration,
dosage form, or strength was approved under paragraph
(2)(C);
(E) if the application was filed pursuant to the
approval of a petition under paragraph (2)(C), the
application did not contain the information required by
the Secretary respecting the active ingredient, route
of administration, dosage form, or strength which is
not the same;
(F) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the listed drug referred to in the application or, if
the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted
in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the
listed drug referred to in paragraph (2)(A)(i) and that
the new drug can be expected to have the same
therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in such
paragraph;
(G) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
listed drug referred to in the application except for
changes required because of differences approved under
a petition filed under paragraph (2)(C) or because the
drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any
other information available to the Secretary shows that
(i) the inactive ingredients of the drug are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the drug, or
(ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive
ingredients included or the manner in which the
inactive ingredients are included;
(I) the approval under subsection (c) of the listed
drug referred to in the application under this
subsection has been withdrawn or suspended for grounds
described in the first sentence of subsection (e), the
Secretary has published a notice of opportunity for
hearing to withdraw approval of the listed drug under
subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this
subsection of the listed drug referred to in the
application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has
determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other
requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of
material fact.
(5)(A) Within one hundred and eighty days of the initial
receipt of an application under paragraph (2) or within such
additional period as may be agreed upon by the Secretary and
the applicant, the Secretary shall approve or disapprove the
application.
(B) The approval of an application submitted under paragraph
(2) shall be made effective on the last applicable date
determined by applying the following to each certification made
under paragraph (2)(A)(vii):
(i) If the applicant only made a certification
described in subclause (I) or (II) of paragraph
(2)(A)(vii) or in both such subclauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described
in subclause (III) of paragraph (2)(A)(vii), the
approval may be made effective on the date certified
under subclause (III).
(iii) If the applicant made a certification described
in subclause (IV) of paragraph (2)(A)(vii), the
approval shall be made effective immediately unless,
before the expiration of 45 days after the date on
which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the
patent that is the subject of the certification and for
which information was submitted to the Secretary under
subsection (b)(1) or (c)(2) before the date on which
the application (excluding an amendment or supplement
to the application), which the Secretary later
determines to be substantially complete, was submitted.
If such an action is brought before the expiration of
such days, the approval shall be made effective upon
the expiration of the thirty-month period beginning on
the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(I) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(aa) the date on which the court
enters judgment reflecting the
decision; or
(bb) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(II) if before the expiration of such period
the district court decides that the patent has
been infringed--
(aa) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(AA) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(BB) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(bb) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(III) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in subclause (II).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a
certification described in paragraph
(2)(A)(vii)(IV) and is for a drug for which a
first applicant has submitted an application
containing such a certification, the
application shall be made effective on the date
that is 180 days after the date of the first
commercial marketing of the drug (including the
commercial marketing of the listed drug) by any
first applicant.
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--
The term ``180-day exclusivity period''
means the 180-day period ending on the
day before the date on which an
application submitted by an applicant
other than a first applicant could
become effective under this clause.
(bb) First applicant.--As used in
this subsection, the term ``first
applicant'' means an applicant that, on
the first day on which a substantially
complete application containing a
certification described in paragraph
(2)(A)(vii)(IV) is submitted for
approval of a drug, submits a
substantially complete application that
contains and lawfully maintains a
certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete
application.--As used in this
subsection, the term ``substantially
complete application'' means an
application under this subsection that
on its face is sufficiently complete to
permit a substantive review and
contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term
``tentative approval'' means
notification to an applicant by
the Secretary that an
application under this
subsection meets the
requirements of paragraph
(2)(A), but cannot receive
effective approval because the
application does not meet the
requirements of this
subparagraph, there is a period
of exclusivity for the listed
drug under subparagraph (F) or
section 505A, or there is a 7-
year period of exclusivity for
the listed drug under section
527.
(BB) Limitation.--A drug that
is granted tentative approval
by the Secretary is not an
approved drug and shall not
have an effective approval
until the Secretary issues an
approval after any necessary
additional review of the
application.
(v) 180-day exclusivity period for competitive
generic therapies.--
(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for
a drug that is the same as a competitive
generic therapy for which any first approved
applicant has commenced commercial marketing,
the application shall be made effective on the
date that is 180 days after the date of the
first commercial marketing of the competitive
generic therapy (including the commercial
marketing of the listed drug) by any first
approved applicant.
(II) Limitation.--The exclusivity period
under subclause (I) shall not apply with
respect to a competitive generic therapy that
has previously received an exclusivity period
under subclause (I).
(III) Definitions.--In this clause and
subparagraph (D)(iv):
(aa) The term ``competitive generic
therapy'' means a drug--
(AA) that is designated as a
competitive generic therapy
under section 506H; and
(BB) for which there are no
unexpired patents or
exclusivities on the list of
products described in section
505(j)(7)(A) at the time of
submission.
(bb) The term ``first approved
applicant'' means any applicant that
has submitted an application that--
(AA) is for a competitive
generic therapy that is
approved on the first day on
which any application for such
competitive generic therapy is
approved;
(BB) is not eligible for a
180-day exclusivity period
under clause (iv) for the drug
that is the subject of the
application for the competitive
generic therapy; and
(CC) is not for a drug for
which all drug versions have
forfeited eligibility for a
180-day exclusivity period
under clause (iv) pursuant to
subparagraph (D).
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
under paragraph (2) for a declaratory
judgment with respect to a patent which
is the subject of the certification
referred to in subparagraph (B)(iii)
unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant under paragraph (2) for
the purpose of determining whether an
action referred to in subparagraph
(B)(iii) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV) and for no other
purpose, and may not disclose
information of no relevance to any
issue of patent infringement to any
person other than a person provided an
offer of confidential access. Further,
the application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or (c) on the
ground that the patent does not claim
either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this
subparagraph, the term ``forfeiture event'',
with respect to an application under this
subsection, means the occurrence of any of the
following:
(I) Failure to market.--The first
applicant fails to market the drug by
the later of--
(aa) the earlier of the date
that is--
(AA) 75 days after
the date on which the
approval of the
application of the
first applicant is made
effective under
subparagraph (B)(iii);
or
(BB) 30 months after
the date of submission
of the application of
the first applicant; or
(bb) with respect to the
first applicant or any other
applicant (which other
applicant has received
tentative approval), the date
that is 75 days after the date
as of which, as to each of the
patents with respect to which
the first applicant submitted
and lawfully maintained a
certification qualifying the
first applicant for the 180-day
exclusivity period under
subparagraph (B)(iv), at least
1 of the following has
occurred:
(AA) In an
infringement action
brought against that
applicant with respect
to the patent or in a
declaratory judgment
action brought by that
applicant with respect
to the patent, a court
enters a final decision
from which no appeal
(other than a petition
to the Supreme Court
for a writ of
certiorari) has been or
can be taken that the
patent is invalid or
not infringed.
(BB) In an
infringement action or
a declaratory judgment
action described in
subitem (AA), a court
signs a settlement
order or consent decree
that enters a final
judgment that includes
a finding that the
patent is invalid or
not infringed.
(CC) The patent
information submitted
under subsection (b) or
(c) is withdrawn by the
holder of the
application approved
under subsection (b).
(II) Withdrawal of application.--The
first applicant withdraws the
application or the Secretary considers
the application to have been withdrawn
as a result of a determination by the
Secretary that the application does not
meet the requirements for approval
under paragraph (4).
(III) Amendment of certification.--
The first applicant amends or withdraws
the certification for all of the
patents with respect to which that
applicant submitted a certification
qualifying the applicant for the 180-
day exclusivity period.
(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 30 months after the
date on which the application is filed,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is filed.
(V) Agreement with another applicant,
the listed drug application holder, or
a patent owner.--The first applicant
enters into an agreement with another
applicant under this subsection for the
drug, the holder of the application for
the listed drug, or an owner of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV), the Federal Trade
Commission or the Attorney General
files a complaint, and there is a final
decision of the Federal Trade
Commission or the court with regard to
the complaint from which no appeal
(other than a petition to the Supreme
Court for a writ of certiorari) has
been or can be taken that the agreement
has violated section 27 of the Federal
Trade Commission Act or the antitrust
laws (as defined in section 1 of the
Clayton Act (15 U.S.C. 12), except that
the term includes section 5 of the
Federal Trade Commission Act (15 U.S.C.
45) to the extent that that section
applies to unfair methods of
competition).
(VI) Expiration of all patents.--All
of the patents as to which the
applicant submitted a certification
qualifying it for the 180-day
exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by a first applicant if a
forfeiture event occurs with respect to that
first applicant.
(iii) Subsequent applicant.--If all first
applicants forfeit the 180-day exclusivity
period under clause (ii)--
(I) approval of any application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall be made
effective in accordance with
subparagraph (B)(iii); and
(II) no applicant shall be eligible
for a 180-day exclusivity period.
(iv) Special forfeiture rule for competitive
generic therapy.--The 180-day exclusivity
period described in subparagraph (B)(v) shall
be forfeited by a first approved applicant if
the applicant fails to market the competitive
generic therapy within 75 days after the date
on which the approval of the first approved
applicant's application for the competitive
generic therapy is made effective.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within
thirty days after such notice, such hearing shall commence not
more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing
final briefs.
(F)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) for a drug, no
active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application
under subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted
effective before the expiration of ten years from the date of
the approval of the application under subsection (b).
(ii) If an application submitted under subsection (b) for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this subsection, no application may be
submitted under this subsection which refers to the drug for
which the subsection (b) application was submitted before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under this subsection after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of
patent invalidity or noninfringement described in subclause
(IV) of paragraph (2)(A)(vii). The approval of such an
application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to
in subparagraph (B)(iii) shall be extended by such amount of
time (if any) which is required for seven and one-half years to
have elapsed from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection (b) for a
drug, which includes an active ingredient (including any ester
or salt of the active ingredient) that has been approved in
another application approved under subsection (b), is approved
after the date of enactment of this subsection and if such
application contains reports of new clinical investigations
(other than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the applicant,
the Secretary may not make the approval of an application
submitted under this subsection for the conditions of approval
of such drug in the subsection (b) application effective before
the expiration of three years from the date of the approval of
the application under subsection (b) for such drug.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment of this
subsection and the supplement contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not
make the approval of an application submitted under this
subsection for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b).
(v) If an application (or supplement to an application)
submitted under subsection (b) for a drug, which includes an
active ingredient (including any ester or salt of the active
ingredient) that has been approved in another application under
subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the
subsection (b) application effective before the expiration of
two years from the date of enactment of this subsection.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was
withdrawn or suspended for grounds described in the first
sentence of subsection (e) or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons,
the approval of the drug under this subsection shall be
withdrawn or suspended--
(A) for the same period as the withdrawal or
suspension under subsection (e) or this paragraph, or
(B) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
(7)(A)(i) Within sixty days of the date of the enactment of
this subsection, the Secretary shall publish and make available
to the public--
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved
for safety and effectiveness under subsection (c)
before the date of the enactment of this subsection;
(II) the date of approval if the drug is approved
after 1981 and the number of the application which was
approved; and
(III) whether in vitro or in vivo bioequivalence
studies, or both such studies, are required for
applications filed under this subsection which will
refer to the drug published.
(ii) Every thirty days after the publication of the first
list under clause (i) the Secretary shall revise the list to
include each drug which has been approved for safety and
effectiveness under subsection (c) or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (b)
or (c) respecting a drug included on the list is to be
published by the Secretary, the Secretary shall, in revisions
made under clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under
subsection (c) or approved under this subsection shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or
was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in
the list under subparagraph (A) or, if the withdrawal or
suspension occurred after its publication in such list, it
shall be immediately removed from such list--
(i) for the same period as the withdrawal or
suspension under subsection (e) or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate
and extent to which the active ingredient or
therapeutic ingredient is absorbed from a drug and
becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may assess
bioavailability by scientifically valid measurements
intended to reflect the rate and extent to which the
active ingredient or therapeutic ingredient becomes
available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to
a listed drug if--
(i) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the listed
drug when administered at the same molar dose
of the therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the listed drug when
administered at the same molar dose of the
therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses and the difference from the
listed drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective body drug
concentrations on chronic use, and is
considered medically insignificant for the
drug.
(C) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may establish
alternative, scientifically valid methods to show
bioequivalence if the alternative methods are expected
to detect a significant difference between the drug and
the listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the
chemistry of the application was assigned and the date
of such assignment, and
(D) the name of each person to whom the
bioequivalence review for such application was assigned
and the date of such assignment.
The information the Secretary is required to maintain under
this paragraph with respect to an application submitted under
this subsection shall be made available to the public after the
approval of such application.
(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
(i) the application is otherwise eligible for
approval under this subsection but for expiration of
patent, an exclusivity period, or of a delay in
approval described in paragraph (5)(B)(iii), and a
revision to the labeling of the listed drug has been
approved by the Secretary within 60 days of such
expiration;
(ii) the labeling revision described under clause (i)
does not include a change to the ``Warnings'' section
of the labeling;
(iii) the sponsor of the application under this
subsection agrees to submit revised labeling of the
drug that is the subject of such application not later
than 60 days after the notification of any changes to
such labeling required by the Secretary; and
(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
(B) If, after a labeling revision described in subparagraph
(A)(i), the Secretary determines that the continued presence in
interstate commerce of the labeling of the listed drug (as in
effect before the revision described in subparagraph (A)(i))
adversely impacts the safe use of the drug, no application
under this subsection shall be eligible for approval with such
labeling.
(11)(A) Subject to subparagraph (B), the Secretary shall
prioritize the review of, and act within 8 months of the date
of the submission of, an original abbreviated new drug
application submitted for review under this subsection that is
for a drug--
(i) for which there are not more than 3 approved drug
products listed under paragraph (7) and for which there
are no blocking patents and exclusivities; or
(ii) that has been included on the list under section
506E.
(B) To qualify for priority review under this paragraph, not
later than 60 days prior to the submission of an application
described in subparagraph (A) or that the Secretary may
prioritize pursuant to subparagraph (D), the applicant shall
provide complete, accurate information regarding facilities
involved in manufacturing processes and testing of the drug
that is the subject of the application, including facilities in
corresponding Type II active pharmaceutical ingredients drug
master files referenced in an application and sites or
organizations involved in bioequivalence and clinical studies
used to support the application, to enable the Secretary to
make a determination regarding whether an inspection of a
facility is necessary. Such information shall include the
relevant (as determined by the Secretary) sections of such
application, which shall be unchanged relative to the date of
the submission of such application, except to the extent that a
change is made to such information to exclude a facility that
was not used to generate data to meet any application
requirements for such submission and that is not the only
facility intended to conduct one or more unit operations in
commercial production. Information provided by an applicant
under this subparagraph shall not be considered the submission
of an application under this subsection.
(C) The Secretary may expedite an inspection or reinspection
under section 704 of an establishment that proposes to
manufacture a drug described in subparagraph (A).
(D) Nothing in this paragraph shall prevent the Secretary
from prioritizing the review of other applications as the
Secretary determines appropriate.
(12) The Secretary shall publish on the internet website of
the Food and Drug Administration, and update at least once
every 6 months, a list of all drugs approved under subsection
(c) for which all patents and periods of exclusivity under this
Act have expired and for which no application has been approved
under this subsection.
(13) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the
Secretary shall, as appropriate, provide review status updates
indicating the categorical status of the applications by each
relevant review discipline.
(k)(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) is in effect, the
applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise
obtained by such applicant with respect to such drug, as the
Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) of this
section. Regulations and orders issued under this subsection
and under subsection (i) shall have due regard for the
professional ethics of the medical profession and the interests
of patients and shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(3) Active postmarket risk identification.--
(A) Definition.--In this paragraph, the term
``data'' refers to information with respect to
a drug approved under this section or under
section 351 of the Public Health Service Act,
including claims data, patient survey data,
standardized analytic files that allow for the
pooling and analysis of data from disparate
data environments, and any other data deemed
appropriate by the Secretary.
(B) Development of postmarket risk
identification and analysis methods.--The
Secretary shall, not later than 2 years after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, in
collaboration with public, academic, and
private entities--
(i) develop methods to obtain access
to disparate data sources including the
data sources specified in subparagraph
(C);
(ii) develop validated methods for
the establishment of a postmarket risk
identification and analysis system to
link and analyze safety data from
multiple sources, with the goals of
including, in aggregate--
(I) at least 25,000,000
patients by July 1, 2010; and
(II) at least 100,000,000
patients by July 1, 2012; and
(iii) convene a committee of experts,
including individuals who are
recognized in the field of protecting
data privacy and security, to make
recommendations to the Secretary on the
development of tools and methods for
the ethical and scientific uses for,
and communication of, postmarketing
data specified under subparagraph (C),
including recommendations on the
development of effective research
methods for the study of drug safety
questions.
(C) Establishment of the postmarket risk
identification and analysis system.--
(i) In general.--The Secretary shall,
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), establish and maintain
procedures--
(I) for risk identification
and analysis based on
electronic health data, in
compliance with the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996, and in a manner
that does not disclose
individually identifiable
health information in violation
of paragraph (4)(B);
(II) for the reporting (in a
standardized form) of data on
all serious adverse drug
experiences (as defined in
section 505-1(b)) submitted to
the Secretary under paragraph
(1), and those adverse events
submitted by patients,
providers, and drug sponsors,
when appropriate;
(III) to provide for active
adverse event surveillance
using the following data
sources, as available:
(aa) Federal health-
related electronic data
(such as data from the
Medicare program and
the health systems of
the Department of
Veterans Affairs);
(bb) private sector
health-related
electronic data (such
as pharmaceutical
purchase data and
health insurance claims
data); and
(cc) other data as
the Secretary deems
necessary to create a
robust system to
identify adverse events
and potential drug
safety signals;
(IV) to identify certain
trends and patterns with
respect to data accessed by the
system;
(V) to provide regular
reports to the Secretary
concerning adverse event
trends, adverse event patterns,
incidence and prevalence of
adverse events, and other
information the Secretary
determines appropriate, which
may include data on comparative
national adverse event trends;
and
(VI) to enable the program to
export data in a form
appropriate for further
aggregation, statistical
analysis, and reporting.
(ii) Timeliness of reporting.--The
procedures established under clause (i)
shall ensure that such data are
accessed, analyzed, and reported in a
timely, routine, and systematic manner,
taking into consideration the need for
data completeness, coding, cleansing,
and standardized analysis and
transmission.
(iii) Private sector resources.--To
ensure the establishment of the active
postmarket risk identification and
analysis system under this subsection
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), as required under clause (i), the
Secretary may, on a temporary or
permanent basis, implement systems or
products developed by private entities.
(iv) Complementary approaches.--To
the extent the active postmarket risk
identification and analysis system
under this subsection is not sufficient
to gather data and information relevant
to a priority drug safety question, the
Secretary shall develop, support, and
participate in complementary approaches
to gather and analyze such data and
information, including--
(I) approaches that are
complementary with respect to
assessing the safety of use of
a drug in domestic populations
not included, or
underrepresented, in the trials
used to approve the drug (such
as older people, people with
comorbidities, pregnant women,
or children); and
(II) existing approaches such
as the Vaccine Adverse Event
Reporting System and the
Vaccine Safety Datalink or
successor databases.
(v) Authority for contracts.--The
Secretary may enter into contracts with
public and private entities to fulfill
the requirements of this subparagraph.
(4) Advanced analysis of drug safety data.--
(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and
private entities, which may include the Centers
for Education and Research on Therapeutics
under section 912 of the Public Health Service
Act, to provide for advanced analysis of drug
safety data described in paragraph (3)(C) and
other information that is publicly available or
is provided by the Secretary, in order to--
(i) improve the quality and
efficiency of postmarket drug safety
risk-benefit analysis;
(ii) provide the Secretary with
routine access to outside expertise to
study advanced drug safety questions;
and
(iii) enhance the ability of the
Secretary to make timely assessments
based on drug safety data.
(B) Privacy.--Such analysis shall not
disclose individually identifiable health
information when presenting such drug safety
signals and trends or when responding to
inquiries regarding such drug safety signals
and trends.
(C) Public process for priority questions.--
At least biannually, the Secretary shall seek
recommendations from the Drug Safety and Risk
Management Advisory Committee (or any successor
committee) and from other advisory committees,
as appropriate, to the Food and Drug
Administration on--
(i) priority drug safety questions;
and
(ii) mechanisms for answering such
questions, including through--
(I) active risk
identification under paragraph
(3); and
(II) when such risk
identification is not
sufficient, postapproval
studies and clinical trials
under subsection (o)(3).
(D) Procedures for the development of drug
safety collaborations.--
(i) In general.--Not later than 180
days after the date of the
establishment of the active postmarket
risk identification and analysis system
under this subsection, the Secretary
shall establish and implement
procedures under which the Secretary
may routinely contract with one or more
qualified entities to--
(I) classify, analyze, or
aggregate data described in
paragraph (3)(C) and
information that is publicly
available or is provided by the
Secretary;
(II) allow for prompt
investigation of priority drug
safety questions, including--
(aa) unresolved
safety questions for
drugs or classes of
drugs; and
(bb) for a newly-
approved drugs, safety
signals from clinical
trials used to approve
the drug and other
preapproval trials;
rare, serious drug side
effects; and the safety
of use in domestic
populations not
included, or
underrepresented, in
the trials used to
approve the drug (such
as older people, people
with comorbidities,
pregnant women, or
children);
(III) perform advanced
research and analysis on
identified drug safety risks;
(IV) focus postapproval
studies and clinical trials
under subsection (o)(3) more
effectively on cases for which
reports under paragraph (1) and
other safety signal detection
is not sufficient to resolve
whether there is an elevated
risk of a serious adverse event
associated with the use of a
drug; and
(V) carry out other
activities as the Secretary
deems necessary to carry out
the purposes of this paragraph.
(ii) Request for specific
methodology.--The procedures described
in clause (i) shall permit the
Secretary to request that a specific
methodology be used by the qualified
entity. The qualified entity shall work
with the Secretary to finalize the
methodology to be used.
(E) Use of analyses.--The Secretary shall
provide the analyses described in this
paragraph, including the methods and results of
such analyses, about a drug to the sponsor or
sponsors of such drug.
(F) Qualified entities.--
(i) In general.--The Secretary shall
enter into contracts with a sufficient
number of qualified entities to develop
and provide information to the
Secretary in a timely manner.
(ii) Qualification.--The Secretary
shall enter into a contract with an
entity under clause (i) only if the
Secretary determines that the entity
has a significant presence in the
United States and has one or more of
the following qualifications:
(I) The research,
statistical, epidemiologic, or
clinical capability and
expertise to conduct and
complete the activities under
this paragraph, including the
capability and expertise to
provide the Secretary de-
identified data consistent with
the requirements of this
subsection.
(II) An information
technology infrastructure in
place to support electronic
data and operational standards
to provide security for such
data.
(III) Experience with, and
expertise on, the development
of drug safety and
effectiveness research using
electronic population data.
(IV) An understanding of drug
development or risk/benefit
balancing in a clinical
setting.
(V) Other expertise which the
Secretary deems necessary to
fulfill the activities under
this paragraph.
(G) Contract requirements.--Each contract
with a qualified entity under subparagraph
(F)(i) shall contain the following
requirements:
(i) Ensuring privacy.--The qualified
entity shall ensure that the entity
will not use data under this subsection
in a manner that--
(I) violates the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996;
(II) violates sections 552 or
552a of title 5, United States
Code, with regard to the
privacy of individually-
identifiable beneficiary health
information; or
(III) discloses individually
identifiable health information
when presenting drug safety
signals and trends or when
responding to inquiries
regarding drug safety signals
and trends.
Nothing in this clause prohibits lawful
disclosure for other purposes.
(ii) Component of another
organization.--If a qualified entity is
a component of another organization--
(I) the qualified entity
shall establish appropriate
security measures to maintain
the confidentiality and privacy
of such data; and
(II) the entity shall not
make an unauthorized disclosure
of such data to the other
components of the organization
in breach of such
confidentiality and privacy
requirement.
(iii) Termination or nonrenewal.--If
a contract with a qualified entity
under this subparagraph is terminated
or not renewed, the following
requirements shall apply:
(I) Confidentiality and
privacy protections.--The
entity shall continue to comply
with the confidentiality and
privacy requirements under this
paragraph with respect to all
data disclosed to the entity.
(II) Disposition of data.--
The entity shall return any
data disclosed to such entity
under this subsection to which
it would not otherwise have
access or, if returning the
data is not practicable,
destroy the data.
(H) Competitive procedures.--The Secretary
shall use competitive procedures (as defined in
section 4(5) of the Federal Procurement Policy
Act) to enter into contracts under subparagraph
(G).
(I) Review of contract in the event of a
merger or acquisition.--The Secretary shall
review the contract with a qualified entity
under this paragraph in the event of a merger
or acquisition of the entity in order to ensure
that the requirements under this paragraph will
continue to be met.
(J) Coordination.--In carrying out this
paragraph, the Secretary shall provide for
appropriate communications to the public,
scientific, public health, and medical
communities, and other key stakeholders, and to
the extent practicable shall coordinate with
the activities of private entities,
professional associations, or other entities
that may have sources of drug safety data.
(5) The Secretary shall--
(A) conduct regular screenings of the Adverse
Event Reporting System database and post a
quarterly report on the Adverse Event Reporting
System Web site of any new safety information
or potential signal of a serious risk
identified by Adverse Event Reporting System
within the last quarter; and
(B) on an annual basis, review the entire
backlog of postmarket safety commitments to
determine which commitments require revision or
should be eliminated, report to the Congress on
these determinations, and assign start dates
and estimated completion dates for such
commitments; and
(C) make available on the Internet website of the
Food and Drug Administration--
(i) guidelines, developed with input from
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs, that detail best
practices for drug safety surveillance using
the Adverse Event Reporting System; and
(ii) criteria for public posting of adverse
event signals.
(l)(1) Safety and effectiveness data and information which
has been submitted in an application under subsection (b) for a
drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless
extraordinary circumstances are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application under subsection (j) which refers to
such drug or upon the date upon which the approval of
an application under subsection (j) which refers to
such drug could be made effective if such an
application had been submitted.
(2) Action Package for Approval.--
(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health
Service Act on the Internet Web site of the Food and
Drug Administration--
(i) not later than 30 days after the date of
approval of such application for a drug no
active ingredient (including any ester or salt
of the active ingredient) of which has been
approved in any other application under this
section or section 351 of the Public Health
Service Act; and
(ii) not later than 30 days after the third
request for such action package for approval
received under section 552 of title 5, United
States Code, for any other drug.
(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet Web site of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of
approval of the drug, except where such materials
require redaction by the Secretary.
(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and
shall include the following:
(i) Documents generated by the Food and Drug
Administration related to review of the
application.
(ii) Documents pertaining to the format and
content of the application generated during
drug development.
(iii) Labeling submitted by the applicant.
(iv) A summary review that documents
conclusions from all reviewing disciplines
about the drug, noting any critical issues and
disagreements with the applicant and within the
review team and how they were resolved,
recommendations for action, and an explanation
of any nonconcurrence with review conclusions.
(v) The Division Director and Office
Director's decision document which includes--
(I) a brief statement of concurrence
with the summary review;
(II) a separate review or addendum to
the review if disagreeing with the
summary review; and
(III) a separate review or addendum
to the review to add further analysis.
(vi) Identification by name of each officer
or employee of the Food and Drug Administration
who--
(I) participated in the decision to
approve the application; and
(II) consents to have his or her name
included in the package.
(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be
altered by management or the reviewer once final.
(E) Confidential information.--This paragraph does
not authorize the disclosure of any trade secret,
confidential commercial or financial information, or
other matter listed in section 552(b) of title 5,
United States Code.
(m) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(n)(1) For the purpose of providing expert scientific advice
and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug
under section 505 or section 351 of the Public Health Service
Act, the Secretary shall establish panels of experts or use
panels of experts established before the date of enactment of
the Food and Drug Administration Modernization Act of 1997, or
both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 1004 to a director of a center
or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall
consist of--
(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and
(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
Scientific, trade, and consumer organizations shall be afforded
an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of
the United States and engaged in the administration of this Act
may be a voting member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman
thereof.
(4) The Secretary shall, as appropriate, provide education
and training to each new panel member before such member
participates in a panel's activities, including education
regarding requirements under this Act and related regulations
of the Secretary, and the administrative processes and
procedures related to panel meetings.
(5) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation for each day so engaged, including
traveltime, at rates to be fixed by the Secretary, but not to
exceed the daily equivalent of the rate in effect for positions
classified above grade GS-15 of the General Schedule. While
serving away from their homes or regular places of business,
panel members may be allowed travel expenses (including per
diem in lieu of subsistence) as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(6) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that any
matter to be reviewed by such a panel can be presented to the
panel not more than 60 days after the matter is ready for such
review. Meetings of the panel may be held using electronic
communication to convene the meetings.
(7) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and
Drug Administration official responsible for the matter shall
review the conclusions and recommendations of the panel, and
notify the affected persons of the final decision on the
matter, or of the reasons that no such decision has been
reached. Each such final decision shall be documented including
the rationale for the decision.
(o) Postmarket Studies and Clinical Trials; Labeling.--
(1) In general.--A responsible person may not
introduce or deliver for introduction into interstate
commerce the new drug involved if the person is in
violation of a requirement established under paragraph
(3) or (4) with respect to the drug.
(2) Definitions.--For purposes of this subsection:
(A) Responsible person.--The term
``responsible person'' means a person who--
(i) has submitted to the Secretary a
covered application that is pending; or
(ii) is the holder of an approved
covered application.
(B) Covered application.--The term ``covered
application'' means--
(i) an application under subsection
(b) for a drug that is subject to
section 503(b); and
(ii) an application under section 351
of the Public Health Service Act.
(C) New safety information; serious risk.--
The terms ``new safety information'', ``serious
risk'', and ``signal of a serious risk'' have
the meanings given such terms in section 505-
1(b).
(3) Studies and clinical trials.--
(A) In general.--For any or all of the
purposes specified in subparagraph (B), the
Secretary may, subject to subparagraph (D),
require a responsible person for a drug to
conduct a postapproval study or studies of the
drug, or a postapproval clinical trial or
trials of the drug, on the basis of scientific
data deemed appropriate by the Secretary,
including information regarding chemically-
related or pharmacologically-related drugs.
(B) Purposes of study or clinical trial.--The
purposes referred to in this subparagraph with
respect to a postapproval study or postapproval
clinical trial are the following:
(i) To assess a known serious risk
related to the use of the drug
involved.
(ii) To assess signals of serious
risk related to the use of the drug.
(iii) To identify an unexpected
serious risk when available data
indicates the potential for a serious
risk.
(C) Establishment of requirement after
approval of covered application.--The Secretary
may require a postapproval study or studies or
postapproval clinical trial or trials for a
drug for which an approved covered application
is in effect as of the date on which the
Secretary seeks to establish such requirement
only if the Secretary becomes aware of new
safety information.
(D) Determination by secretary.--
(i) Postapproval studies.--The
Secretary may not require the
responsible person to conduct a study
under this paragraph, unless the
Secretary makes a determination that
the reports under subsection (k)(1) and
the active postmarket risk
identification and analysis system as
available under subsection (k)(3) will
not be sufficient to meet the purposes
set forth in subparagraph (B).
(ii) Postapproval clinical trials.--
The Secretary may not require the
responsible person to conduct a
clinical trial under this paragraph,
unless the Secretary makes a
determination that a postapproval study
or studies will not be sufficient to
meet the purposes set forth in
subparagraph (B).
(E) Notification; timetables; periodic
reports.--
(i) Notification.--The Secretary
shall notify the responsible person
regarding a requirement under this
paragraph to conduct a postapproval
study or clinical trial by the target
dates for communication of feedback
from the review team to the responsible
person regarding proposed labeling and
postmarketing study commitments as set
forth in the letters described in
section 101(c) of the Food and Drug
Administration Amendments Act of 2007.
(ii) Timetable; periodic reports.--
For each study or clinical trial
required to be conducted under this
paragraph, the Secretary shall require
that the responsible person submit a
timetable for completion of the study
or clinical trial. With respect to each
study required to be conducted under
this paragraph or otherwise undertaken
by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such study
including whether any difficulties in
completing the study have been
encountered. With respect to each
clinical trial required to be conducted
under this paragraph or otherwise
undertaken by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such
clinical trial including whether
enrollment has begun, the number of
participants enrolled, the expected
completion date, whether any
difficulties completing the clinical
trial have been encountered, and
registration information with respect
to the requirements under section
402(j) of the Public Health Service
Act. If the responsible person fails to
comply with such timetable or violates
any other requirement of this
subparagraph, the responsible person
shall be considered in violation of
this subsection, unless the responsible
person demonstrates good cause for such
noncompliance or such other violation.
The Secretary shall determine what
constitutes good cause under the
preceding sentence.
(F) Dispute resolution.--The responsible
person may appeal a requirement to conduct a
study or clinical trial under this paragraph
using dispute resolution procedures established
by the Secretary in regulation and guidance.
(4) Safety labeling changes requested by secretary.--
(A) New safety or new effectiveness
information.--If the Secretary becomes aware of
new information, including any new safety
information or information related to reduced
effectiveness, that the Secretary determines
should be included in the labeling of the drug,
the Secretary shall promptly notify the
responsible person or, if the same drug
approved under section 505(b) is not currently
marketed, the holder of an approved application
under 505(j).
(B) Response to notification.--Following
notification pursuant to subparagraph (A), the
responsible person or the holder of the
approved application under section 505(j) shall
within 30 days--
(i) submit a supplement proposing
changes to the approved labeling to
reflect the new safety information,
including changes to boxed warnings,
contraindications, warnings,
precautions, or adverse reactions, or
new effectiveness information; or
(ii) notify the Secretary that the
responsible person or the holder of the
approved application under section
505(j) does not believe a labeling
change is warranted and submit a
statement detailing the reasons why
such a change is not warranted.
(C) Review.--Upon receipt of such supplement,
the Secretary shall promptly review and act
upon such supplement. If the Secretary
disagrees with the proposed changes in the
supplement or with the statement setting forth
the reasons why no labeling change is
necessary, the Secretary shall initiate
discussions to reach agreement on whether the
labeling for the drug should be modified to
reflect the new safety or new effectiveness
information, and if so, the contents of such
labeling changes.
(D) Discussions.--Such discussions shall not
extend for more than 30 days after the response
to the notification under subparagraph (B),
unless the Secretary determines an extension of
such discussion period is warranted.
(E) Order.--Within 15 days of the conclusion
of the discussions under subparagraph (D), the
Secretary may issue an order directing the
responsible person or the holder of the
approved application under section 505(j) to
make such a labeling change as the Secretary
deems appropriate to address the new safety or
new effectiveness information. Within 15 days
of such an order, the responsible person or the
holder of the approved application under
section 505(j) shall submit a supplement
containing the labeling change.
(F) Dispute resolution.--Within 5 days of
receiving an order under subparagraph (E), the
responsible person or the holder of the
approved application under section 505(j) may
appeal using dispute resolution procedures
established by the Secretary in regulation and
guidance.
(G) Violation.--If the responsible person or
the holder of the approved application under
section 505(j) has not submitted a supplement
within 15 days of the date of such order under
subparagraph (E), and there is no appeal or
dispute resolution proceeding pending, the
responsible person or holder shall be
considered to be in violation of this
subsection. If at the conclusion of any dispute
resolution procedures the Secretary determines
that a supplement must be submitted and such a
supplement is not submitted within 15 days of
the date of that determination, the responsible
person or holder shall be in violation of this
subsection.
(H) Public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary
concludes that such a labeling change is
necessary to protect the public health, the
Secretary may accelerate the timelines in such
subparagraphs.
(I) Rule of construction.--This paragraph
shall not be construed to affect the
responsibility of the responsible person or the
holder of the approved application under
section 505(j) to maintain its label in
accordance with existing requirements,
including subpart B of part 201 and sections
314.70 and 601.12 of title 21, Code of Federal
Regulations (or any successor regulations).
(5) Non-delegation.--Determinations by the Secretary
under this subsection for a drug shall be made by
individuals at or above the level of individuals
empowered to approve a drug (such as division directors
within the Center for Drug Evaluation and Research).
(p) Risk Evaluation and Mitigation Strategy.--
(1) In general.--A person may not introduce or
deliver for introduction into interstate commerce a new
drug if--
(A)(i) the application for such drug is
approved under subsection (b) or (j) and is
subject to section 503(b); or
(ii) the application for such drug is
approved under section 351 of the Public Health
Service Act; and
(B) a risk evaluation and mitigation strategy
is required under section 505-1 with respect to
the drug and the person fails to maintain
compliance with the requirements of the
approved strategy or with other requirements
under section 505-1, including requirements
regarding assessments of approved strategies.
(2) Certain postmarket studies.--The failure to
conduct a postmarket study under section 506, subpart H
of part 314, or subpart E of part 601 of title 21, Code
of Federal Regulations (or any successor regulations),
is deemed to be a violation of paragraph (1).
(q) Petitions and Civil Actions Regarding Approval of Certain
Applications.--
(1) In general.--
(A) Determination.--The Secretary shall not
delay approval of a pending application
submitted under subsection (b)(2) or (j) of
this section or section 351(k) of the Public
Health Service Act because of any request to
take any form of action relating to the
application, either before or during
consideration of the request, unless--
(i) the request is in writing and is
a petition submitted to the Secretary
pursuant to section 10.30 or 10.35 of
title 21, Code of Federal Regulations
(or any successor regulations); and
(ii) the Secretary determines, upon
reviewing the petition, that a delay is
necessary to protect the public health.
Consideration of the petition shall be separate
and apart from review and approval of any
application.
(B) Notification.--If the Secretary
determines under subparagraph (A) that a delay
is necessary with respect to an application,
the Secretary shall provide to the applicant,
not later than 30 days after making such
determination, the following information:
(i) Notification of the fact that a
determination under subparagraph (A)
has been made.
(ii) If applicable, any clarification
or additional data that the applicant
should submit to the docket on the
petition to allow the Secretary to
review the petition promptly.
(iii) A brief summary of the specific
substantive issues raised in the
petition which form the basis of the
determination.
(C) Format.--The information described in
subparagraph (B) shall be conveyed via either,
at the discretion of the Secretary--
(i) a document; or
(ii) a meeting with the applicant
involved.
(D) Public disclosure.--Any information
conveyed by the Secretary under subparagraph
(C) shall be considered part of the application
and shall be subject to the disclosure
requirements applicable to information in such
application.
(E) Denial based on intent to delay.--If the
Secretary determines that a petition or a
supplement to the petition was submitted with
the primary purpose of delaying the approval of
an application and the petition does not on its
face raise valid scientific or regulatory
issues, the Secretary may deny the petition at
any point based on such determination. The
Secretary may issue guidance to describe the
factors that will be used to determine under
this subparagraph whether a petition is
submitted with the primary purpose of delaying
the approval of an application.
(F) Final agency action.--The Secretary shall
take final agency action on a petition not
later than 150 days after the date on which the
petition is submitted. The Secretary shall not
extend such period for any reason, including--
(i) any determination made under
subparagraph (A);
(ii) the submission of comments
relating to the petition or
supplemental information supplied by
the petitioner; or
(iii) the consent of the petitioner.
(G) Extension of 30-month period.--If the
filing of an application resulted in first-
applicant status under subsection
(j)(5)(D)(i)(IV) and approval of the
application was delayed because of a petition,
the 30-month period under such subsection is
deemed to be extended by a period of time equal
to the period beginning on the date on which
the Secretary received the petition and ending
on the date of final agency action on the
petition (inclusive of such beginning and
ending dates), without regard to whether the
Secretary grants, in whole or in part, or
denies, in whole or in part, the petition.
(H) Certification.--The Secretary shall not
consider a petition for review unless the party
submitting such petition does so in written
form and the subject document is signed and
contains the following certification: ``I
certify that, to my best knowledge and belief:
(a) this petition includes all information and
views upon which the petition relies; (b) this
petition includes representative data and/or
information known to the petitioner which are
unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any
representative data and/or information which
are unfavorable to the petition were disclosed
to me. I further certify that the information
upon which I have based the action requested
herein first became known to the party on whose
behalf this petition is submitted on or about
the following date: __________. If I received
or expect to receive payments, including cash
and other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations:
_____________. I verify under penalty of
perjury that the foregoing is true and correct
as of the date of the submission of this
petition.'', with the date on which such
information first became known to such party
and the names of such persons or organizations
inserted in the first and second blank space,
respectively.
(I) Verification.--The Secretary shall not
accept for review any supplemental information
or comments on a petition unless the party
submitting such information or comments does so
in written form and the subject document is
signed and contains the following verification:
``I certify that, to my best knowledge and
belief: (a) I have not intentionally delayed
submission of this document or its contents;
and (b) the information upon which I have based
the action requested herein first became known
to me on or about __________. If I received or
expect to receive payments, including cash and
other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations: _____. I
verify under penalty of perjury that the
foregoing is true and correct as of the date of
the submission of this petition.'', with the
date on which such information first became
known to the party and the names of such
persons or organizations inserted in the first
and second blank space, respectively.
(2) Exhaustion of administrative remedies.--
(A) Final agency action within 150 days.--The
Secretary shall be considered to have taken
final agency action on a petition if--
(i) during the 150-day period
referred to in paragraph (1)(F), the
Secretary makes a final decision within
the meaning of section 10.45(d) of
title 21, Code of Federal Regulations
(or any successor regulation); or
(ii) such period expires without the
Secretary having made such a final
decision.
(B) Dismissal of certain civil actions.--If a
civil action is filed against the Secretary
with respect to any issue raised in the
petition before the Secretary has taken final
agency action on the petition within the
meaning of subparagraph (A), the court shall
dismiss without prejudice the action for
failure to exhaust administrative remedies.
(C) Administrative record.--For purposes of
judicial review related to the approval of an
application for which a petition under
paragraph (1) was submitted, the administrative
record regarding any issue raised by the
petition shall include--
(i) the petition filed under
paragraph (1) and any supplements and
comments thereto;
(ii) the Secretary's response to such
petition, if issued; and
(iii) other information, as
designated by the Secretary, related to
the Secretary's determinations
regarding the issues raised in such
petition, as long as the information
was considered by the agency no later
than the date of final agency action as
defined under subparagraph (2)(A), and
regardless of whether the Secretary
responded to the petition at or before
the approval of the application at
issue in the petition.
(3) Annual report on delays in approvals per
petitions.--The Secretary shall annually submit to the
Congress a report that specifies--
(A) the number of applications that were
approved during the preceding 12-month period;
(B) the number of such applications whose
effective dates were delayed by petitions
referred to in paragraph (1) during such
period;
(C) the number of days by which such
applications were so delayed; and
(D) the number of such petitions that were
submitted during such period.
(4) Exceptions.--
(A) This subsection does not apply to--
(i) a petition that relates solely to
the timing of the approval of an
application pursuant to subsection
(j)(5)(B)(iv); or
(ii) a petition that is made by the
sponsor of an application and that
seeks only to have the Secretary take
or refrain from taking any form of
action with respect to that
application.
(B) Paragraph (2) does not apply to a
petition addressing issues concerning an
application submitted pursuant to section
351(k) of the Public Health Service Act.
(5) Definitions.--
(A) Application.--For purposes of this
subsection, the term ``application'' means an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act.
(B) Petition.--For purposes of this
subsection, other than paragraph (1)(A)(i), the
term ``petition'' means a request described in
paragraph (1)(A)(i).
(r) Postmarket Drug Safety Information for Patients and
Providers.--
(1) Establishment.--Not later than 1 year after the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary
shall improve the transparency of information about
drugs and allow patients and health care providers
better access to information about drugs by developing
and maintaining an Internet Web site that--
(A) provides links to drug safety information
listed in paragraph (2) for prescription drugs
that are approved under this section or
licensed under section 351 of the Public Health
Service Act; and
(B) improves communication of drug safety
information to patients and providers.
(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
(A) developing and maintaining an accessible,
consolidated Internet Web site with easily
searchable drug safety information, including
the information found on United States
Government Internet Web sites, such as the
United States National Library of Medicine's
Daily Med and Medline Plus Web sites, in
addition to other such Web sites maintained by
the Secretary;
(B) ensuring that the information provided on
the Internet Web site is comprehensive and
includes, when available and appropriate--
(i) patient labeling and patient
packaging inserts;
(ii) a link to a list of each drug,
whether approved under this section or
licensed under such section 351, for
which a Medication Guide, as provided
for under part 208 of title 21, Code of
Federal Regulations (or any successor
regulations), is required;
(iii) a link to the registry and
results data bank provided for under
subsections (i) and (j) of section 402
of the Public Health Service Act;
(iv) the most recent safety
information and alerts issued by the
Food and Drug Administration for drugs
approved by the Secretary under this
section, such as product recalls,
warning letters, and import alerts;
(v) publicly available information
about implemented RiskMAPs and risk
evaluation and mitigation strategies
under subsection (o);
(vi) guidance documents and
regulations related to drug safety; and
(vii) other material determined
appropriate by the Secretary;
(C) providing access to summaries of the
assessed and aggregated data collected from the
active surveillance infrastructure under
subsection (k)(3) to provide information of
known and serious side-effects for drugs
approved under this section or licensed under
such section 351;
(D) preparing and making publicly available
on the Internet website established under
paragraph (1) best practices for drug safety
surveillance activities for drugs approved
under this section or section 351 of the Public
Health Service Act;
(E) enabling patients, providers, and drug
sponsors to submit adverse event reports
through the Internet Web site;
(F) providing educational materials for
patients and providers about the appropriate
means of disposing of expired, damaged, or
unusable medications; and
(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes
of the Internet Web site.
(3) Posting of drug labeling.--The Secretary shall
post on the Internet Web site established under
paragraph (1) the approved professional labeling and
any required patient labeling of a drug approved under
this section or licensed under such section 351 not
later than 21 days after the date the drug is approved
or licensed, including in a supplemental application
with respect to a labeling change.
(4) Private sector resources.--To ensure development
of the Internet Web site by the date described in
paragraph (1), the Secretary may, on a temporary or
permanent basis, implement systems or products
developed by private entities.
(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to
fulfill the requirements of this subsection.
(6) Review.--The Advisory Committee on Risk
Communication under section 567 shall, on a regular
basis, perform a comprehensive review and evaluation of
the types of risk communication information provided on
the Internet Web site established under paragraph (1)
and, through other means, shall identify, clarify, and
define the purposes and types of information available
to facilitate the efficient flow of information to
patients and providers, and shall recommend ways for
the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk
communication information to patients and providers.
(s) Referral to Advisory Committee.--Prior to the approval of
a drug no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under this section or section 351 of the Public
Health Service Act, the Secretary shall--
(1) refer such drug to a Food and Drug Administration
advisory committee for review at a meeting of such
advisory committee; or
(2) if the Secretary does not refer such a drug to a
Food and Drug Administration advisory committee prior
to the approval of the drug, provide in the action
letter on the application for the drug a summary of the
reasons why the Secretary did not refer the drug to an
advisory committee prior to approval.
(t) Database for Authorized Generic Drugs.--
(1) In general.--
(A) Publication.--The Commissioner shall--
(i) not later than 9 months after the
date of the enactment of the Food and
Drug Administration Amendments Act of
2007, publish a complete list on the
Internet Web site of the Food and Drug
Administration of all authorized
generic drugs (including drug trade
name, brand company manufacturer, and
the date the authorized generic drug
entered the market); and
(ii) update the list quarterly to
include each authorized generic drug
included in an annual report submitted
to the Secretary by the sponsor of a
listed drug during the preceding 3-
month period.
(B) Notification.--The Commissioner shall
notify relevant Federal agencies, including the
Centers for Medicare & Medicaid Services and
the Federal Trade Commission, when the
Commissioner first publishes the information
described in subparagraph (A) that the
information has been published and that the
information will be updated quarterly.
(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic
drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug after January
1, 1999.
(3) Authorized generic drug.--In this section, the
term ``authorized generic drug'' means a listed drug
(as that term is used in subsection (j)) that--
(A) has been approved under subsection (c);
and
(B) is marketed, sold, or distributed
directly or indirectly to retail class of trade
under a different labeling, packaging (other
than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use
in institutions), product code, labeler code,
trade name, or trade mark than the listed drug.
(u) Certain Drugs Containing Single Enantiomers.--
(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
submitted under subsection (b) for a non-racemic drug
containing as an active ingredient (including any ester
or salt of the active ingredient) a single enantiomer
that is contained in a racemic drug approved in another
application under subsection (b), the applicant may, in
the application for such non-racemic drug, elect to
have the single enantiomer not be considered the same
active ingredient as that contained in the approved
racemic drug, if--
(A)(i) the single enantiomer has not been
previously approved except in the approved
racemic drug; and
(ii) the application submitted under
subsection (b) for such non-racemic drug--
(I) includes full reports of new
clinical investigations (other than
bioavailability studies)--
(aa) necessary for the
approval of the application
under subsections (c) and (d);
and
(bb) conducted or sponsored
by the applicant; and
(II) does not rely on any clinical
investigations that are part of an
application submitted under subsection
(b) for approval of the approved
racemic drug; and
(B) the application submitted under
subsection (b) for such non-racemic drug is not
submitted for approval of a condition of use--
(i) in a therapeutic category in
which the approved racemic drug has
been approved; or
(ii) for which any other enantiomer
of the racemic drug has been approved.
(2) Limitation.--
(A) No approval in certain therapeutic
categories.--Until the date that is 10 years
after the date of approval of a non-racemic
drug described in paragraph (1) and with
respect to which the applicant has made the
election provided for by such paragraph, the
Secretary shall not approve such non-racemic
drug for any condition of use in the
therapeutic category in which the racemic drug
has been approved.
(B) Labeling.--If applicable, the labeling of
a non-racemic drug described in paragraph (1)
and with respect to which the applicant has
made the election provided for by such
paragraph shall include a statement that the
non-racemic drug is not approved, and has not
been shown to be safe and effective, for any
condition of use of the racemic drug.
(3) Definition.--
(A) In general.--For purposes of this
subsection, the term ``therapeutic category''
means a therapeutic category identified in the
list developed by the United States
Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and
as in effect on the date of the enactment of
this subsection.
(B) Publication by secretary.--The Secretary
shall publish the list described in
subparagraph (A) and may amend such list by
regulation.
(4) Availability.--The election referred to in
paragraph (1) may be made only in an application that
is submitted to the Secretary after the date of the
enactment of this subsection and before October 1,
2022.
(v) Antibiotic Drugs Submitted Before November 21, 1997.--
(1) Antibiotic drugs approved before november 21,
1997.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) shall be eligible for, with
respect to the drug, the 3-year exclusivity
period referred to under clauses (iii) and (iv)
of subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
an application approved by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997).
(2) Antibiotic drugs submitted before november 21,
1997, but not approved.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) may elect to be eligible
for, with respect to the drug--
(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and
(iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements
of such clauses, as applicable; and
(II) the 5-year exclusivity period
referred to under clause (ii) of
subsection (c)(3)(E) and under clause
(ii) of subsection (j)(5)(F), subject
to the requirements of such clauses, as
applicable; or
(ii) a patent term extension under
section 156 of title 35, United States
Code, subject to the requirements of
such section.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
1 or more applications received by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997), none of which was approved by
the Secretary under such section.
(3) Limitations.--
(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to
entitle a drug that is the subject of an
approved application described in subparagraphs
(1)(B)(i) or (2)(B)(i), as applicable, to any
market exclusivities or patent extensions other
than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of
use for which the drug referred to in
subparagraph (1)(B)(i) or (2)(B)(i), as
applicable, was approved before the date of the
enactment of this subsection.
(4) Application of certain provisions.--
Notwithstanding section 125, or any other provision, of
the Food and Drug Administration Modernization Act of
1997, or any other provision of law, and subject to the
limitations in paragraphs (1), (2), and (3), the
provisions of the Drug Price Competition and Patent
Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to
which an election is made under paragraph (2)(A).
(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.
(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to issue a scientific and medical
evaluation and recommend controls under the Controlled
Substances Act, approval of such application shall not
take effect until the interim final rule controlling
the drug is issued in accordance with section 201(j) of
the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
(1) In general.--The sponsor of a contrast agent for
which an application has been approved under this
section may submit a supplement to the application
seeking approval for a new use following the
authorization of a premarket submission for an
applicable medical imaging device for that use with the
contrast agent pursuant to section 520(p)(1).
(2) Review of supplement.--In reviewing a supplement
submitted under this subsection, the agency center
charged with the premarket review of drugs may--
(A) consult with the center charged with the
premarket review of devices; and
(B) review information and data submitted to
the Secretary by the sponsor of an applicable
medical imaging device pursuant to section 515,
510(k), or 513(f)(2) so long as the sponsor of
such applicable medical imaging device has
provided to the sponsor of the contrast agent a
right of reference.
(3) Definitions.--For purposes of this subsection--
(A) the term ``new use'' means a use of a
contrast agent that is described in the
approved labeling of an applicable medical
imaging device described in section 520(p), but
that is not described in the approved labeling
of the contrast agent; and
(B) the terms ``applicable medical imaging
device'' and ``contrast agent'' have the
meanings given such terms in section 520(p).
* * * * * * *
Additional Views
During the Committee's consideration of this bill, concerns
arose about the bill's approach and possible unintended
consequences of enacting it as drafted. This legislation
accordingly warranted further deliberation by this Committee
before any additional legislative action.
Guy Reschenthaler,
Member.
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