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Republic of the Philippines Department of Health

Food and Drug Administration

Draft Administrative Order Specific Policies Governing Brand

Names of Pharmaceutical Products


Pharmaceutical Associations 22 May 2014

Conference Room, 2nd Flr FDA Main Building 1

Discussion Flow I. Background II. Objectives III. Scope IV. General Guidelines V. Requirements for a Brand

Name VI. Transitory Provisions VII. Discussion

Center for Drug Regulation and Research

2



Center for Drug Regulation and Research 3

BACKGROUND

Background Part of the registration process – evaluation

and approval of brand names to implement misbranding provisions of RA 3720

However – issues have been raised


Background


Background AO No. 131 s. 1970: Regulation Part C-3.2: Drugs: Prohibition of Use of More Than One Name for a Given Formulation


Background AO No. 38 s. 1979: Restriction on the Use of Several Brand Names for a Formulation of a Drug or Pharmaceutical Specialty


Background AO No. 38 s. 1979: Restriction on the Use of Several Brand Names for a Formulation of a Drug or Pharmaceutical Specialty


Amended by AO 42 s. 1979

Background AO No. 42 s. 1979


Background AO No. 76 s. 1984: Guidelines to be Observed by FDA in Clearance of Name Relative to Food, Drugs, and Cosmetics




Revoked by AO No. 2006-0016

Background MC No. 10-a s. 1992: Registration of Branded Version of Registered Unbranded Generic Drug Product, and Generic Version of Unregistered Branded Drug Products


Background MC No. 16-A s. 1994: Limiting the Number of Proposed Brand Name for Brand Name Clearance for a Single Drug Product or Pharmaceutical Specialty


Background BC No. 21 s. 1999: Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs




Revoked by AO No. 2006-0016

Background BC No. 22 s. 1999: Deletion of the Requirement for a Certificate of Brand Name Clearance in Filing an Application for Registration of Branded Products


Background AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs


Background PSD Memo 07-2005: Procedure for the Submission of Proposed Brand Names


Approach Creation of a specific guideline/policy for

brand name of drug products

Adopt previous guidelines/policies which may still be applicable





OBJECTIVES

Objectives promote the rational use of drugs

prevent medication errors and potential harm to the public by setting specific policies and guidelines for the evaluation and approval of brand names





SCOPE

Scope all manufacturers, traders and distributors (e.g. exporters, importers and wholesalers) of pharmaceutical products





GENERAL GUIDELINES

General Guidelines A. specific pharmaceutical product

formulation may be marketed by its MAH under its generic name or together with its brand name

B. a MAH shall be allowed to register an unbranded counterpart – both subject to initial registration


General Guidelines C. Any name may be accepted as the brand

name – meets the requirements

D. FDA reserves the right to disapprove brand names





REQUIREMENTS FOR A BRAND NAME

AO No. 2005-0016 Not allowed:

1) identical to those already registered with FDA

2) offensive, obscene, scandalous, or otherwise contrary to public morals and policy


Additional Requirements

A. Deceptively descriptive brand names;

B. Refer to a specific person, place, or event that which may give false impressions about the product;


Additional Requirements C. Confusing:

1) In speech, in rhyme or in writing (sound alike, look alike names);

2) Similar or identical with the first and/or last syllables of another brand name, unless other syllables create a distinctive appearance or sound; they must be different either in prefix, middle or suffix syllables if applied to different generic class of drug or where the drugs have different indications;


Additional Requirements C. Confusing:

3) Use of a single brand name for a wide range of pharmaceutical formulation by a single MAH. This is allowed if a qualifier (e.g., XY-100, XY-300; XY, XY-Forte;)is included

4) a brand name similar to an INN that is not its generic name (e.g., Mefen for Ibuprofen)


Additional Requirements

identical nor similar to the World Health Organization (WHO) List of Recommended and Proposed INN, United States Approved Name (USAN), Compendial Name, or any other well established chemical names


Similarity to INNs

Changing or dropping a single letter or syllable from the INN (e.g., Paracetam for Paracetamol);

Inclusion of INN stems, as provided under WHO List of Common Stems (e.g., Laracillin, -cillin is an INN stem); and

Combining INN elements for a multi-component product (e.g., Sulfaprim for Sulfadoxine and trimethoprim).


Similarity to INNs

Any revisions and supplements to the WHO List of Recommended and Proposed INN, and List of Common Stems shall be automatically adopted





TRANSITORY PROVISIONS

Transitory Provisions shall apply 1 year after effectivity

all previously cleared brand names that may be contrary to the provisions of this AO, clearance for the respective brand names shall be secured upon submission of MAHs of their applications for renewal registration





DISCUSSION

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