The document provides an overview of the Waxman-Hatch Act of 1984, which established the modern generic drug approval pathway in the United States. It discusses the reasons for its creation, key provisions such as bioequivalence standards and patent certification requirements, and subsequent amendments. The Act sought to balance increased availability of low-cost generic drugs with incentives for continued pharmaceutical innovation.

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The Basics of The Waxman-Hatch Act
Center for Professional Advancement
Generic Drug Approvals Course – August 2013
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice

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Why The 1984 Law Was Created
• Difficulty in obtaining an ANDA for post-1962
drugs
• Erosion of patent protection for pioneer drugs
due to lengthy FDA approval process
• Increased pressure for competitive pricing
• Federal government’s role as major drug
purchaser

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Statutory Sections - NDAs
FDCA § 505(b)(1)
“Any person may file with the Secretary [FDA] an application with
respect to any [new] drug . . .” {21 U.S.C. § 355(b)(1)}
FDCA § 505(b)(2)
“An application . . . for a [new] drug for which the [safety and
effectiveness] investigations . . . 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
. . .” {21 U.S.C. § 355(b)(2)}

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Waxman-Hatch Basics
• Any person could file an ANDA for a drug approved
under § 505(b) of the Federal Food, Drug, and
Cosmetic Act
• Requirements
– Same active ingredient
– Same conditions of use (labeling)
– Same dosage form
– Same strength
– Same route of admin.
– Bioequivalent
– Patent Certification

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Basics …
• ANDA Suitability Petitions – for some changes
• Listing of patents and approved drugs – the
“Orange Book”
• Patent term restoration –
– On new chemical entities – maximum is five years
– Formula = 50% development time + 100% review time (less
any non-diligent time) up to 5 years with a maximum length
after extension of 14 years

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Basics …
• Exclusivity
– 5-year – NCE
– 3-year – new uses for previously approved drugs
 New clinical investigations
 Conducted or sponsored
 By applicant
 Essential to approval

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Basics …
• Patent listings
– 30 days of new approval
– 30 days of issuance if drug already approved
• Patent Certifications
– I – no information filed
– II – filed patent has expired
– III – will await patent expire
– IV – won’t infringe or patent invalid – requires notice to patent
holder with detailed statement of law and fact for why patent
should not block ANDA

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Another Waxman-Hatch Creation –
The 505(b)(2) NDA
• Not a completely new product (usually)
• Not a generic
• A product with some differences from a previously
approved product
• Approval requires (usually) clinical data, but the
studies may have been conducted by others.

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How is 505(b)(2) Different?
• The applicant and FDA may rely on prior FDA
safety and efficacy determinations, based on
studies conducted by someone else even though
the applicant does not have a right of reference to
the data. 21 U.S.C. § 355(b)(2)
• Safety and efficacy can also be supported by
published reports

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Types of 505(b)(2) NDAs
• New Chemical Entity (rarely)
• Changes to a Previously Approved Drug
– New dosage form, dosing regimen, strength, or route of
administration
– New indication
– New active ingredient
– New inactive ingredient that requires studies beyond
limited confirmatory studies
– Rx  OTC switch (Claritin)
• Duplicates of approved drugs that cannot be
approved under an ANDA

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Patent and Exclusivity Issues of
505(b)(2) Applications
• 505(b)(2) NDA must include patent
certification(s).
• 505(b)(2) NDA must also list any relevant
patent(s).
• Same Paragraph IV challenge system as ANDAs,
EXCEPT, no 180-day exclusivity period.
• A 505(b)(2) product may itself qualify for 3 or 5
years of new drug exclusivity

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Safe Harbor for ANDA R&D on Patent-
Protected RLD
• History: Court held “patent infringement” includes
precommercial testing of product
(flurazepam/Dalmane®)
(Roche v. Bolar, Federal Circuit, 1984)
• Waxman Hatch Act -- Overturned Roche v. Bolar –
– may make, use or sell a patented drug during the patent life
if solely for uses reasonably related to the development and
submission of information under a federal law which
regulates the manufacture, use or sale of drugs

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Safe Harbor for ANDA R&D on Patent-
Protected RLD
• Safe Harbor -- applies to innovator and generic firms
(Bristol-Myers Squibb v. Rhone-Poulenc Rorer, S.D.N.Y. 2001, aff’d, 3rd
Circuit, 2003)
• “Reasonably Related” -- means having a decent prospect that the
“use” would generate the kind of information relevant to FDA
approval requirements
– Construed:
 Intermedics v. Ventritex, N.D.Ca. 1991, aff’d, Federal Circuit, 1993 – clinical
trials on intermediates, yes
 Medtronic v. Lohr, U.S. Supreme Court, 1996 – applies to medical devices
 Integra Life Sciences v. Merck, U.S. Supreme Court, 2005 – preclinical
research to identify future candidate, yes

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The Concept of the Listed Drug
• Required for ANDA Approval
• Generic must be the same as the RLD
• Before 1984 – Federal Register Notices Declared
DESI Drugs to be “Effective”
• Now Appear in FDA’s Orange Book, updated
monthly

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Electronic Orange Book
Source: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

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Electronic Orange Book
• Search in 3 Databases
– Rx
– OTC
– Discontinued
 Request FDA Determination that RLD Was Not Withdrawn
from the Market for Reasons of Safety or Efficacy
 FDA Answers: Approved Discontinued Drug Products
Safety and Effectiveness Determinations

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Bioequivalence
• Clinical Comparison of Generic and RLD
• No Significant Difference in the Rate and Extent
to which the Active Ingredient Becomes Available
at the Site of Drug Action
• Details in Next Lecture

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Statutory Exclusivities Under
Waxman-Hatch
• New Chemical Entity (NCE) Exclusivity
– Prohibits the filing of an ANDA (or 505(b)(2) NDA) for
a product that contains the NCE for 5 years after
approval of the first NDA.
 (4 years if ANDA includes a Paragraph IV challenge to
listed patent)
– NCE: "a drug that contains no active moiety that has
been approved by FDA in any other [NDA]."

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Statutory Exclusivities …
• 3-Year Exclusivity
– Available for NDAs which contain:
 Reports of "new" "clinical trials"
 That were "essential to approval" of the NDA
 Conducted or sponsored by the applicant
– FDA may not approve an ANDA or 505(b)(2) NDA for 3
years after approval
– Applies for new indications, Rx  OTC switch, new
dosing regimen, and some other labeling changes.

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Statutory Exclusivities -- Other
• Orphan Drug Exclusivity
– 7 year exclusivity
– Drugs for rare conditions (<200,000 people in U.S.)
• Pediatric Exclusivity
– 6-month extension of existing patent or Waxman-Hatch
exclusivity
• 180-day generic (ANDA) exclusivity

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“180-Day” or “ANDA” Exclusivity
• Basics:
– First person to file an ANDA with a Paragraph IV
certification gets 180 days during which no other ANDA
can be approved for that drug
– Must either (a) not be sued by brand co. in 45-day period or
(b) prevail in litigation (or get favorable settlement)
– 180 days starts from earlier of:
 Date of first commercial marketing (changed in 2003;
used to peg to a court decision as well)

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FDA Amendments Act of 2007 (FDAAA)
• Post Labeling of RLD 21 days after approval
• Post Approval Package 30 days after approval
• Database For Authorized Generic Drugs
– FDA must publish a complete list on its Internet site of all
authorized generic drugs, updated quarterly
– Drug trade name, brand manufacturer, and date the
authorized generic drug entered the market
– Drugs marketed, sold, or distributed directly or indirectly to
retail class of trade with either labeling, packaging, product
code, labeler code, trade name, or trade mark that differs
from that of the RLD

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FDA Amendments Act of 2007 (FDAAA)
• Clinical Trial Registry Databank
– Not required for blood-level bio studies
– May be required for clinical bio studies (e.g., topical dosage
forms) - controversial
• Citizen Petitions
– Shall not delay ANDA approvals unless necessary for
public health
– If delay, 30-day notice to ANDA applicant
– Denial permitted based on Petitioner’s intent to delay
– Certify that Info became known on XX date

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OGD Statistics
25
Source: “Update on the Office of Generic Drugs,” by Robert Pollock,
Senior Advisor and Outside Director, Lachman Consultants, at Orange
County Regulatory Affairs Annual Conference, June 13, 2013.
2013 315 194 (5/31)
TOTAL 4,803 2,556

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Backlog – Pending ANDAs
Source: “Generic Drug Submissions,” by Michael Swit, in Fundamentals of US
Regulatory Affairs, 8th Ed., Chapter 13, Regulatory Affairs Professionals
Society. 2013.26

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Backlog – Median Approval Times
Source: “Generic Drug Submissions,” by Michael Swit, in Fundamentals of US
Regulatory Affairs, 8th Ed., Chapter 13, Regulatory Affairs Professionals
Society. 2013.27

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Backlog – DMF Filings
28
Source: “Overview of GDUFA and Applications Under GDUFA,” by
Thomas Hinchliffe, Pharm.D., Special Assistant to Director, Office of
Generic Drugs, at FDA GDUFA and You Conference, June 12-13, 2013.

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Inspections – Finished Dosage Form
29
Source: “Overview of GDUFA and Applications Under GDUFA,” by
Thomas Hinchliffe, Pharm.D., Special Assistant to Director, Office of
Generic Drugs, at FDA GDUFA and You Conference, June 12-13, 2013.

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Inspections -- API
30
Source: “Overview of GDUFA and Applications Under GDUFA,” by
Thomas Hinchliffe, Pharm.D., Special Assistant to Director, Office of
Generic Drugs, at FDA GDUFA and You Conference, June 12-13, 2013.

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What’s in a Name?
• Drug Price Competition and Patent Term
Restoration Act of 1984
• “Waxman-Hatch Act” – universally called that until
1994
• 1994 – Republicans take control of Congress – “Hatch-
Waxman Act”
• 2006 – Democrats take control of Congress
• So what do you call it now? – well, the first part of the
statutory name – Drug Price Competition – relates to
Waxman’s role; and the second part – Patent Term
Restoration – refers to Hatch’s role in pushing the 1984
compromise.