Draft Administrative Order Specific Policies Governing Brand Names - PowerPoint PPT Presentation

Republic of the Philippines Department of Health Food and Drug Administration Draft Administrative Order Specific Policies Governing Brand Names of Pharmaceutical Products Food and Drug Administration 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

Republic of the Philippines Department of Health Food and Drug Administration BACKGROUND Center for Drug Regulation and Research 3

Background  Part of the registration process – evaluation and approval of brand names to implement misbranding provisions of RA 3720  However – issues have been raised Center for Drug Regulation and Research 4

Background Center for Drug Regulation and Research 5

Background Center for Drug Regulation and Research 6

Center for Drug Regulation and Research 7

Background AO No. 131 s. 1970: Regulation Part C-3.2: Drugs: Prohibition of Use of More Than One Name for a Given Formulation Center for Drug Regulation and Research 8

Background AO No. 131 s. 1970: Regulation Part C-3.2: Drugs: Prohibition of Use of More Than One Name for a Given Formulation Center for Drug Regulation and Research 9

Background AO No. 38 s. 1979: Restriction on the Use of Several Brand Names for a Formulation of a Drug or Pharmaceutical Specialty Center for Drug Regulation and Research 10

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 Center for Drug Regulation and Research 11

Background AO No. 42 s. 1979 Center for Drug Regulation and Research 12

Background AO No. 42 s. 1979 Center for Drug Regulation and Research 13

Background AO No. 76 s. 1984: Guidelines to be Observed by FDA in Clearance of Name Relative to Food, Drugs, and Cosmetics Center for Drug Regulation and Research 14

Background AO No. 76 s. 1984: Guidelines to be Observed by FDA in Clearance of Name Relative to Food, Drugs, and Cosmetics Center for Drug Regulation and Research 15

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 Center for Drug Regulation and Research 16

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 Center for Drug Regulation and Research 17

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 Center for Drug Regulation and Research 18

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 Center for Drug Regulation and Research 19

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 Center for Drug Regulation and Research 20

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 Center for Drug Regulation and Research 21

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 Center for Drug Regulation and Research 22

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 Center for Drug Regulation and Research 23

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 Center for Drug Regulation and Research 24

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 Center for Drug Regulation and Research 25

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 Center for Drug Regulation and Research 26

Background AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs Center for Drug Regulation and Research 27

Background AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs Center for Drug Regulation and Research 28

Background AO No. 2005-0016: General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs Center for Drug Regulation and Research 29

Background PSD Memo 07-2005: Procedure for the Submission of Proposed Brand Names Center for Drug Regulation and Research 30

Approach  Creation of a specific guideline/policy for brand name of drug products  Adopt previous guidelines/policies which may still be applicable Center for Drug Regulation and Research 31

Republic of the Philippines Department of Health Food and Drug Administration OBJECTIVES Center for Drug Regulation and Research 32

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 Center for Drug Regulation and Research 33

Republic of the Philippines Department of Health Food and Drug Administration SCOPE Center for Drug Regulation and Research 34

Scope all manufacturers, traders and distributors (e.g. exporters, importers and wholesalers) of pharmaceutical products Center for Drug Regulation and Research 35

Republic of the Philippines Department of Health Food and Drug Administration GENERAL GUIDELINES Center for Drug Regulation and Research 36

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 Center for Drug Regulation and Research 37

General Guidelines C. Any name may be accepted as the brand name – meets the requirements D. FDA reserves the right to disapprove brand names Center for Drug Regulation and Research 38

Republic of the Philippines Department of Health Food and Drug Administration REQUIREMENTS FOR A BRAND NAME Center for Drug Regulation and Research 39

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 Center for Drug Regulation and Research 40

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; Center for Drug Regulation and Research 41

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; Center for Drug Regulation and Research 42

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) Center for Drug Regulation and Research 43

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 Center for Drug Regulation and Research 44

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). Center for Drug Regulation and Research 45

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 Center for Drug Regulation and Research 46

Republic of the Philippines Department of Health Food and Drug Administration TRANSITORY PROVISIONS Center for Drug Regulation and Research 47