otc drug review, drug amendent, copy right, patent and trade

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

OTC DRUG REVIEW

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

07-Jan-15LS1154 M.THILAKAR 3

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.


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


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


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


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.


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.


HISTORICAL DEVELOPMENT OF

OTC DRUG REGULATION


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


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


Example of a Final OTC Drug Monograph:

Antacid


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.


DRUG AMENDENT

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.


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.


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.


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.


PATENTS

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.07-Jan-15LS1154 M.THILAKAR 24

COPY RIGHT

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


DESIGN RIGHTS

Designs may be subject to both copyright and design rights. They may also be

registered in a similar way to patents.


TRADE MARK or SERVICE MARK

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".


REFERENCES

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







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

16-SEPT-14LS 1154 - M.THILAKAR 33

Thank you dudes…!!!!

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