Include information about Hatch- waxmann act and amendments, this also include information about post marketing survillance

1. Presented by: Mrunal More
1st year M.pharm(Pharmaceutics)
AISSMS College of Pharmacy,Pune.
HATCH-WAXMAN ACT
&
AMENDMENTS
POST MARKETING SURVILLANCE

2. *INTRODUCTION
*OBJECTIVES OF THE ACT
*DRUG APPROVAL
*NEW BRANDED DRUG APPROVAL
*GENERIC DRUG APPROVAL
*CONCLUSION
*BONUS

3. Also known as “THE DRUG PRICE COMPETITION AND
PATENT TERM RESTORATION ACT” .
Enacted in 1984
Amended the patent laws
Before 1962- new drug approval based on safety alone
In 1962-proof of efficacy made compulsory for marketing
approval of a new drug
There was no provision for patent term extension prior to
enactment of the hatch-waxman act to make up for the
time lost out of the total patent term during the marketing
approval process

4. Generic companies were required to submit their own
comprehensive NDA which were costly & time consuming.
To overcome the above problems, an act was needed to
promote generic companies.

5. Reducing the cost associated with the approval of a
generic drug.
Allowing early-experimental use.
Compensating the branded drugs manufacturers for the
time lost from the patent term because of the regulatory
approval formality.
Motivating the generic drug manufacturers.

6. The FDA requires every new drug, including generic drugs,
to be safe and effective.
Before the adoption of the Hatch- Waxman Act, the FDA
required branded and generic drug companies alike to
demonstrate the safety and efficacy of their products in the
same manner through a New Drug Application (NDA) .

7. The Hatch-Waxman Act changed certain aspects of the
new drug application process and the new drug’s patent
term.
In addition, the Hatch-Waxman Act created an
abbreviated process to allow generic drug companies to
obtain FDA approval of generic drugs. Because of this,
today it is far easier for generic drug companies to
demonstrate the safety and efficacy of their generic drugs.

8. A branded drug company seeking FDA approval to market a
new drug must submit an NDA to the FDA. The information
provided in the NDA allows the FDA to determine whether:
1)The new drug is both safe and effective. 2)Certain other
regulatory requirements are met, such as those concerning
labeling and good manufacturing processes.
Obtaining and submitting this information frequently is a
time-consuming process requiring the branded drug company
to conduct many extensive and expensive clinical trials.

9. The FDA reviews generic drug applications for compliance
with the appropriate scientific and regulatory criteria. If an
application meets those criteria, the FDA may grant either: a)
Tentative approval b) Final approval
Under the Hatch-Waxman Act, generic drug companies can
typically file one of two different kinds of abbreviated
applications for approval of a generic drug:
a)An Abbreviated New Drug Application (ANDA)
b)A Section 505(b)(2) application, which is often called a
paper NDA.

10. Under an ANDA, a generic drug company must establish
that the generic drug is effectively a duplicate of the
branded, NDA drug, which is referred to as the Reference
Listed Drug (RLD). Specifically, the generic drug company
must show that the proposed generic drug:
a)Has the same active ingredient, route of administration,
dosage form, strength and intended use as the RLD.
b) Is bioequivalent with the RLD, so that it performs in the
same manner as the RLD in the body.

11. A proposed generic drug may differ in significant ways
from the RLD.
Under these circumstances, the proposed generic drug
must be approved through the Section 505(b)(2) paper NDA
application process, which is a hybrid of a full NDA and an
ANDA. This application includes less data than an NDA but
more data than an ANDA.

12. A)Non-patent Exclusivities
(1.) Orphan drug exclusivity, which is granted to drugs:
a)that treat a disease or condition that affects less than
200,000 people in the US; or
b)for which it is unlikely that US sales of the drug will
recoup its development costs.
This exclusivity period is seven years, but only applies to
use in treating the specific rare disease or condition.

13. (2) New chemical entity (NCE) exclusivity.
This is granted if the FDA has not previously approved
the “active drug moiety.”
NCE exclusivity bars a generic drug company from filing
an application for approval of a generic drug five years
from the first approval of the relevant NDA.
However, a generic drug company may file an ANDA with
a Paragraph IV certification four years after the first NDA
approval

14. (3)New clinical study exclusivity.
This applies when new clinical studies lead to new or
changed formulations, dosing regimens or patient
population.
The applicant is entitled to this exclusivity if an
application or supplement contains reports of new clinical
investigations conducted or sponsored by the applicant that
were essential for approval.
This exclusivity, sometimes called data exclusivity,
prohibits the FDA from approving a generic drug application
for the new dosage form or use for three years after the
first NDA approval.
However, it does not otherwise bar approval of generic
drug applications.

15. (4)Pediatric exclusivity
This applies if the FDA requested that the NDA holder
conduct studies with the drug in pediatric populations.
Pediatric exclusivity adds six months of exclusivity to any
marketing or patent exclusivity.

16. NON PATENT EXCLUSIVITY
TYPES TERM
NEW CHEMICAL ENTITY EXCLUSIVITY 5 YEARS
NEW CLINICAL STUDY EXCLUSIVITY 3 YEARS
ORPHAN DRUG EXCLUSIVITY 7 YEARS
PEDIATRIC EXCLUSIVITY 6 MONTHS
180 DAYS GENERIC MARKET
EXCLUSIVITY
180 DAYS

17. B) Patent exclusivity & the orange book
An NDA holder must provide the FDA with the patent number
and expiration date of any patent that claims either:
a)The drug, including the active ingredient and the
formulation for the active ingredient.
b)A method of using the drug, but not other inventions such
as:
;-metabolites;
;-synthetic intermediates; or
;-methods of making the drug.
When the FDA approves the NDA, the FDA publishes the
patent information in the FDA’s Approved Drug Products with
Therapeutic Equivalence Determinations publication (also
called the Orange book)

18. PATENT TERM EXTENSION
The Hatch-Waxman Act provides a patent term extension for
patents covering certain products and methods, including
human drug products, that are subject to FDA approval. Only
one extension can be granted in connection with a particular
product, and it must be for a patent that claims either a:
a)Drug product, which means the active ingredient and any
approved drug using that active ingredient.
b)Method of using a drug product.
c)Method of manufacturing a drug product

19. Various time periods concerning aspects of the litigation
that may affect the FDA’s approval process
Certain defenses and counterclaims that drug companies
may raise
Specific remedies the parties tend to seek
Unique challenges in entering into settlement agreements

20. The hatch-waxman act provides an expedited USFDA
program for speedy generic entry and market exclusivity
The hatch-waxman act allows for a patent term extension
of a maximum of 5 years for the branded drug manufacturer
to compensate for the time lost during the NDA approval by
the USFDA.

21. *https://www.fda.gov/drugs/abbreviated-new-drug-
application-anda/hatch-waxman-letters
*https://www.fda.gov/drugs/drug-and-biologic-
approval-and-ind-activity-reports/first-generic-drug-
approvals
*https://www.fda.gov/drugs/types-applications/new-
drug-application-nda

23. *Introduction
*Advantages
*Source of the information
*Need of it
*Method of PMS
*Reference

25. To market a drug, the manufacturer must provide evidence
of its efficacy and safety to the U.S food and drug
administration and specified regulatory authorities.
In premarketing testing, the numbers and types of patients
used to demonstrate a drug's efficacy and safety are limited
compared with the numbers and types of patients who will
eventually be prescribed the drug after it is marketed.
Post-marketing surveillance of drug therefore play an
important role to discover an undesirable effect that might
present at RISK.
It provides additional information on the benefits and risk of
the drugs.

26. No fixed Duration / patient population.
Starts immediately after marketing .
Report all ADRs
Helps to detect :
Rare ADR’s Drug Interaction’s .
Also new uses for drugs {Sometimes called Phase V}

27. The following maybe considered as sources of information,
Some sources are pro active and some are reactive
* Expert users groups ("focus groups').
* Customer surveys.
* Customer complaints and warranty claims.
* Post CE(clinical evaluation)-market clinical trials.
* Literature reviews.
* Device tracking/implant registries.
* User reactions during training programmers.
* The media.

28. The primary objective of post-marketing studies is to
develop information about drug effects under customary
conditions of the drug use.
Access to more patients and better data.
Given diversity of data sources, innovative approaches to
retrieval of key data may have great potential vs. single
unified system.
Better background rates, comparable "control" populations.
Increase in "non-medical' data sources e.g., pharmacy,
supermarket, employer vaccination.
All patients vaccinations and health outcomes are
immediately and continuously accessible in automated
database allowing optimal detection and analysis are
applicable to safety initiatives for other medical products.

29. Thus, four types of studies are generally used to
identify drug effects: (3c’s)
Controlled clinical trials,
Spontaneous or voluntary reporting
Cohort studies, and
Case-control studies

30. Controlled clinical trials:
PMS studies conducted after the launch of a product is part
of Phase IV development of the drug. Some of these studies
may be retrospective case-control evaluations. These are
done to evaluate rare suspected side effects.
Cohort studies:
These studies are a type of medical research used to
investigate the cause of disease, establishing links between
risk factors and health out comes. Cohort studies are usually
forward looking that is , they are “prospective” studies
planned in advance and carried out over a future period of
time.

31. Spontaneous or voluntary
reporting:
Spontaneous reports are, by definition, submitted
voluntarily although under certain circumstances these
reports may be encouraged, or "stimulated", by media
reports or articles published in medical or scientific
publications, or by product lawsuits.
In many parts of the world adverse event reports are
submitted electronically using a defined message standard
by physicians and other health providers & hospitals which
may act to alert FDA and pharmaceutical firms to possible
adverse effects of drugs.

32. Case-control studies :
Case-control studies identify patients
with the adverse effects to be studied
(the cases), and compare them with a
sample (the controls), drawn from the
same cohort that gave rise to the cases.

33. THANK YOU
FOR YOUR
ATTENTION
ANY QUESTIONS?