OTC DRUG REVIEW, DRUG AMENDENT, COPY RIGHT, PATENT AND TRADE

1. OTC DRUG REVIEW
DRUG AMENDENT
PATENTS
COPY RIGHT
TRADE
LS1154
M.THILAKAR
4’th M.Sc. LIFE SCIENCES,
BHARATHIDASAN
UNIVERSITY
TRUCHIRAPALLI
BIOPROSPECTING, DRUG DISCOVERY
AND PRODUCT DEVELOPMENT

2. OTC DRUG REVIEW

3. OTC vs PRESCRIPTION DRUG PRODUCT
OTC DRUG PRODUCT
 Over The Counter Drug.
 An OTC drug product is a drug product
marketed for use by the consumer without
the intervention of a health care
professional in order to obtain the product.
PRESCRIPTION DRUG
PRODUCT
 A prescription drug product is a
drug product approved for
marketing that can only be
obtained with a prescription
from an appropriate health care
practitioner
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5. OTC REGUALTORY PATHWAYS
 Two post-1938 regulatory pathways exist for the legal marketing of such products:
 Marketing in compliance with an OTC drug monograph
 Marketing under the authority of an approved product-specific new drug
application (NDA), or an abbreviated new drug application (ANDA).
 Two regulatory pathways :
 OTC New Drug Application (NDA) and
 OTC Drug Monograph or Review.
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6. WHAT ARE THE REQUIREMENTS FOR
ALL OTC DRUG PRODUCTS?
 Standards for safety and efficacy :
 Same standards as prescription drugs
 Also, consumers must be able to Self - diagnose, treat and manage
 Which can be assessed through Label comprehension studies and Actual use studies
 Good Manufacturing Practices and OTC Labeling & Advertising :
 FDA regulates OTC drug labeling by Acts.
 Labeling means all labels, and other written, printed, or graphic matter.
1. upon any article or any of its containers, or
2. accompanying such article“ Drug Facts” ”
 Standardized labeling format as Nutrition Facts
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7. OTC DRUG REVIEW
 The Over-the-Counter (OTC) Drug Review was established to evaluate the
safety and effectiveness of OTC drug products marketed in the United States
before May 11, 1972.
 It is a three-phase public rulemaking process resulting in the establishment of
standards (drug monographs) for an OTC therapeutic drug class.
 Consists of 3 phases :
1. Accomplished by advisory review panels
2. The agency’s review of active ingredients in each class of drugs
3. The publication of final regulations in the form of drug monographs
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8. 1. ACCOMPLISHED BY ADVISORY REVIEW PANELS
 The panels were charged with reviewing the active ingredients in OTC drug products to
determine whether these ingredients could be generally recognized as safe and
effective for use in self-treatment.
 They were also charged with reviewing claims and recommending appropriate labeling,
including therapeutic indications, dosage instructions, and warnings about side effects
and preventing misuse.
 The agency published the panel’s conclusions in the Federal Register in the form of an
Advanced Notice of Proposed Rulemaking (ANPR).
 After publication of the ANPR, a period of time was allotted for interested parties to submit
comments or data in response to the proposal.
 According to the terms of the review, the panels classified ingredients in three
categories as follows:
Category I: generally recognized as safe and effective for the claimed therapeutic
indication;
Category II: not generally recognized as safe and effective or unacceptable indications;
Category III: insufficient data available to permit final classification
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9. 2. THE AGENCY’S REVIEW OF ACTIVE
INGREDIENTS IN EACH CLASS OF DRUGS
 The second phase of the OTC Drug Review is the agency’s review of active
ingredients in each class of drugs, based on the panel’s review of ingredients,
on public comment, and on new data that may have become available.
 The agency, in turn, publishes its conclusions in the Federal Register in the
form of a Tentative Final Monograph (TFM).
 After publication of the TFM, a period of time is allotted for interested parties
to submit comments or data in response to the agency’s proposal.
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10. 3. THE PUBLICATION OF FINAL REGULATIONS
IN THE FORM OF DRUG MONOGRAPHS
 The publication of final regulations in the form of drug monographs is the
third and last phase of the review process.
 The monographs establish conditions under which certain OTC drug products
are generally recognized as safe and effective.
 Products containing active ingredients or indications that are non-monograph
require an approved New Drug Application for marketing.
 After publication, a final monograph may be amended by the Commissioner’s
own initiative or upon the petition of any interested person.
 OTC drug monographs are continually updated to add, change or remove
ingredients, labeling, or other pertinent information, as needed.
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11. HISTORICAL DEVELOPMENT OF
OTC DRUG REGULATION
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12. NDA PROCESS vs. OTC MONOGRAPH
PROCESS
S. NO NDA PROCESS OTC MONOGRAPH PROCESS
1 Pre-market approval No Pre-market approval
2 Confidential filing Public process
3 Drug product-specific Active ingredient :
Specific OTC drug category
4 May require a user fee No user fees
5 Potential for marketing exclusivity No marketing exclusivity
6 Mandated FDA review timelines No mandated timelines
7 May require clinical studies
label comprehension
actual use
May require clinical studies
label comprehension and
actual use studies not required
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13. OTC MONOGRAPH
 The OTC monographs represent regulatory standards for the marketing of non-prescription drug
products not covered by new drug applications.
 These standards provide the marketing conditions for some OTC drug products including the
active ingredients, labeling, and other general requirements.
 It is the Recipe book for marketing an OTC drug.
 A list and explanation of GRASE conditions
 GRASE = Generally Recognized As Safe and Effective
 OTC MONOGRAPH INCLUDES :
 GRASE active ingredients
 Dosage strength
 Dosage form
 Labeling requirements
 Indications
 Warning & Directions for use
 Final formulation testing
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14. Example of a Final OTC Drug Monograph:
Antacid
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15. How is an OTC Monograph established?
 Advisory review panels → expert recommendation
 Three-step rulemaking process
1. Advanced notice of proposed rule making
2. Tentative Final monograph
3. Final monograph
 17 advisory review panels created Antacid Panel, Antimicrobial Panel, Antiperspirant Panel,
Dental Panel, Cough/Cold Panel etc.
 9 member panels : Physicians, pharmacists, toxicologist, industry representative, consumer
representative
 Reviewed 14,000 volumes of data submitted by industry, healthcare professionals, and consumers
Held public meetings.
 Advisory panels will publish as categories. They are as follows
1. GRASE
2. NOT GRASE
3. CANNOT DETERMINE IF SAFE AND EFFECTIVE.
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17. DRUG AMENDENT

18. DRUG AMENDENT
 The U.S. Kefauver Harris Amendment or "Drug
Efficacy Amendment" is a 1962 amendment to the
Federal Food, Drug, and Cosmetic Act.
 It introduced a requirement for drug manufacturers
to provide proof of the effectiveness and safety of
their drugs before the approval, required drug
advertising to disclose accurate information about
side effects, and stopped cheap generic drugs being
marketed as expensive drugs under new trade
names as new "breakthrough" medications.
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20. BACKGROUND SOURCE
 The amendment was a response to the Thalidomide tragedy, in which thousands
of children were born with birth defects as a result of their mothers taking
thalidomide for morning sickness during pregnancy in Europe.
 It should be noted that Thalidomide had not been approved for use in the United
States and that the tragic birth defects that occurred were in other countries.
 FRANCES OLDHAM KELSEY was the FDA reviewer who refused to approve
Thalidomide for use.
 It introduced a "proof-of-efficacy" requirement, that was not present before.
 In addition, the Amendment required drug advertising to disclose accurate
information about side effects and efficacy of treatments.
 Finally, cheap generic drugs could no longer be marketed as expensive drugs
under new trade names as new "breakthrough" medications as they were prior to
the amendment.
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21. EFFECT
 The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's
control of experimentation on humans and changed the way new drugs are approved and
regulated.
 Before the Thalidomide scandal in Europe, U.S. drug companies only had to show their
new products were safe.
 After the passage of the Amendment, an FDA New Drug Application (NDA) would have
to show that a new drug was both safe and effective (previously the 1938 Food, Drug
and Cosmetic Act was the main law that regulated drug safety).
 The Drug Efficacy Study Implementation was begun to classify all pre-1962 drugs
that were already on the market as either effective, ineffective, or needing
further study.
 Estes Kefauver considered the Amendment his "finest achievement" in consumer
protection.
 The law also exempted from the "Delaney clause" (a 1958 amendment to the Food, Drugs,
and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce
cancer, but which left no detectable levels of residue in the human food supply.
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22. THE MAJOR CHANGES
 The new authorities given to FDA by the Kefauver-Harris Amendments:
 Required that manufacturers prove the effectiveness of drug products before they go on
the market, and afterwards report any serious side effects.
 Required that evidence of effectiveness be based on adequate and well-controlled
clinical studies conducted by qualified experts.
 It gave FDA 180 days to approve a new drug application, and required FDA approval
before the drug could be marketed in the United States.
 Allowed FDA to set good manufacturing practices for industry and mandated
regular inspections of production facilities.
 Transferred to FDA control of prescription drug advertising, which would have to
include accurate information about side effects.
 Controlled the marketing of generic drugs to keep them from being sold as
expensive medications under new trade names.
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23. PATENTS

24. PATENTS
 A patent for an invention is the grant of a property right to the inventor, issued by the Patent and
Trademark Office.
 The term of a new patent is 20 years from the date on which the application for the patent was
filed in the United States or in special cases, from the date an earlier related application was
filed subject to the payment of maintenance fees.
 The right conferred by the patent grant is, in the language of the statute and of the grant itself,
"the right to exclude others from making, using, offering for sale, or selling" the invention in the
United States or "importing" the invention into the United States.
 What is granted is not the right to make, use, offer for sale, sell or import, but the right to
exclude others from making, using, offering for sale, selling or importing the invention.
 Patents works a bit differently from copyrights, but you can think of them as copyrights for
inventions.
 All a patent really does is give the patent-holder the right to stop others from producing, selling
or using his or her invention.
 Unlike copyrights, patents protect the idea or design of the invention, rather than any
tangible form of the invention, and so patenting something is a much trickier procedure than
copyrighting something.
 Patents provide protection for 20 years. After that, the invention is public property.
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25. COPY RIGHT

26. ©
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27. COPY RIGHT
 Copyright is a form of protection provided to the authors of "original works of authorship" including
literary, dramatic, musical, artistic and certain other intellectual works, both published and
unpublished.
 The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the
copyrighted work, to prepare derivative works, to distribute copies or photorecords of the copyrighted
work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
 The copyright protects the form of expression rather than the subject matter of the writing.
 For example, a description of a machine could be copyrighted, but this would only prevent others
from copying the description;
 It would not prevent others from writing a description of their own or from making and using the
machine.
 Copyrights are registered by the Copyright Office of the Library of Congress.
 A copyright notice includes three basic elements:
 The word "Copyright," the abbreviation "Copr.," or the symbol "©"
 The year of first publication
 The name of the copyright holder
 EX : © 2011 PARTHA SARATHY
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28. DESIGN RIGHTS
 Designs may be subject to both copyright and design rights. They may also be
registered in a similar way to patents.
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29. TRADE MARK or
SERVICE MARK

30. TRADE MARK or SERVICE MARK
 A trademark is a word, name, symbol or device which is used in trade with
goods to indicate the source of the goods and to distinguish them from the
goods of others.
 A service mark is the same as a trademark except that it identifies and
distinguishes the source of a service rather than a product.
 The terms "trademark" and "mark" are commonly used to refer to both
trademarks and servicemarks.
 Trademark rights may be used to prevent others from using a confusingly
similar mark, but not to prevent others from making the same goods or from
selling the same goods or services under a clearly different mark.
 Trademarks which are used in interstate or foreign commerce may be
registered with the Patent and Trademark Office.
 The registration procedure for trademarks and general information
concerning trademarks is described in a separate pamphlet entitled "Basic
Facts about Trademarks".
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31. REFERENCES

32. REFERENCES
 Over-the-Counter (OTC) Drug Products. Introduction to Drug Law and
Regulation: OTC Monograph System by Debra S. Dunne, R.Ph., Esq.
 http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm
 http://www.fda.gov/drugs/developmentapproval.htm
 http://www.fda.gov/Drugs/DevelopmentApprovalProcess.htm
 http://en.wikipedia.org/wiki/Over-the-counter_drug
 http://en.wikipedia.org/wiki/Kefauver_Harris_Amendment
 http://www.fda.gov/ForConsumers/ConsumerUpdate
 http://www.lawmart.com/forms/difference.htm
 http://money.howstuffworks.com/question492.htm
 http://www.copyrightservice.co.uk/copyright/inteleucatal.htm
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Thank you dudes…!!!!