No. 65 s. 1989
SUBJECT: Guidelines on Advertisement and Promotions to Implement The Generics Act Of 1988
SUMMARY: Pursuant to the “Generic’s Act of 1988”, the “Food, Drugs and Devices and Cosmetics Act” and the Executive Order No. 119, all advertising and promotional materials shall feature prominently the product’s generic name. In the case of branded products, the prominence of the generic name shall be insured in all print, visual or auditory materials that feature the brand name. Self regulation is encouraged and no prior BFAD clearance is required.
Pursuant to Section 6 (c) of R.A. 6675 known as “Generics Act of 1988”. Section 3 (c) of R.A. 3720 known as “Food, Drugs and Devices and Cosmetics Act, and Executive Order No. 119 dated January 30, 1987, the following rules and regulations on the advertisement and promotions of pharmaceutical products are hereby promulgated:
Section 1.0 Definition of Terms
1.1 “Advertisement” includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any pharmaceutical product.
1.2 “Promotion” means the practice of giving temporary additional value to a brand, product, or service to achieve specific marketing objectives. “Promotion” includes the distribution of free/sample pharmaceutical products.
1.3 “Pharmaceutical product” means any pharmaceutical or biological product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man or animals.
1.4 “Prescription or Ethical Drugs” are pharmaceutical products or drug preparations that are to be dispensed only upon written order of a dulylicensed physician, dentist, or veterinarian for the treatment of a condition or a diagnosed disease of man or animals.
1.5 “Non-prescription Drugs” or “Over-the-Counter Drugs” are pharmaceutical products or drug preparations that can be dispensed even without the written order of a duly-licensed physician, dentist, or veterinarian, for the use of consumers for the prevention of symptomatic relief of minor or self-limiting ailments.
1.6 “Mass Media” means any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print media, radio, television, cinema, mobile audiovisual units or any other widespread medium of information directed to the lay public.
Section 2.0 Guidelines On Advertisement And Promotion Based On Prior Laws
2.1 No person shall advertise or promote a pharmaceutical product unless such product is duly-registered by Bureau of Food and Drugs (BFAD).
2.2 All therapeutic claims for drugs, medicines or any pharmaceutical product made in advertising or promotional materials must be based on adequate scientific pharmacological, and clinical evidence, responsible medical opinion or long experience demonstrating their safety, efficacy and therapeutic value, and must be within their therapeutic indications approved by the BFAD.
2.3 No pharmaceutical product classified by BFAD as a Prescription or Ethical Drug shall be advertised or promoted in any form of mass media except through medical journals, publications and/or literature solely intended for medical and allied professions.
2.4 The pharmaceutical company which owns the pharmaceutical product, and its Medical Director shall be responsible and accountable for the content and form of its advertisement and promotional materials.
Section 3.0 Guidelines On Advertisement And Promotion To Implement Section 6 (C) Of The Generics Act Of 1988 (R.A. 6675)
3.1 General Principle
Consistent with Section 6 (c) of RA 6675, all advertising and promotional materials, whether print, visual or auditory, shall feature prominently the generic name of the drug product designated by BFAD. In the case of branded products, the prominence of the generic name shall be insured in all print, visual or auditory materials that feature the brand name.
3.2 Print and Static Visual Materials, (e.g. Posters, Billboards)
The pertinent provisions of A.O. 55 s. 1988 on Requirements for Labelling Materials of Pharmaceutical Products quoted hereunder shall apply with the exception that the word “label” will be substituted by “advertising and other promotional material.”
3.1.1 In all cases, the generic name shall be prominently printed element on the [label] ‘advertising and other promotional material’ defined as the one with the highest point size among the various printed elements on the [label] ‘advertising and other promotional material.’ It shall be enclosed exclusively by an outlined box rendered in the same color as the generic name. The background color inside the box, against which the generic name is rendered, should be the same color as the background color outside the box, against which the brand name is rendered.”
3.1.2 In all cases, the generic name shall be printed in full, not abbreviated and in accordance with the International Non- Proprietary Name (INN). In case the salt or the specific chemical form of the drug needs to be indicated, this must be included inside the box but in smaller point size.”
3.1.3 If a product is identified by a brand name together with its generic name, the following shall be required in addition to 3.1.1 and 3.1.2.”
188.8.131.52 The generic name and brand name shall be rendered using the same typeface, font and color with the generic name appearing immediately above the brand name and rendered in a point size bigger that the brand name.”
184.108.40.206 If the brand name is presented using a special typeface exclusively designed and used for it, the generic name shall be rendered in Helvetica Medium or Univers Medium while complying with the other pertinent provisions above.”
3.3 Other Visual Materials
For other forms of visual materials, such as television, cinema or movies, etc. the general principle in 3.1 will be applied, and consistent with A.O. 55 s. 1988 as amended, the generic name designated by BFAD shall appear prominently within the outlined box, immediately above and in larger point-size that the brand name, if any.
3.4 Auditory Materials
For auditory materials used in radio or other media, the general principle in 3.1 will be adopted according to the convention of medium.
Section 4.0 Monitoring and Enforcement
4.1 The drug establishment under whose name the drug product is registered shall be responsible for ensuring that its advertisement and other promotional materials comply with guidelines. It shall establish suitable mechanism for internally reviewing such materials, specifically with the participation of its medical directors.
4.2 In addition, the drug establishment may participate in other industry-wide mechanism for self-or voluntary regulation. Such participation, however, shall not in anyway diminish the fundamental responsibility and accountability of the drug establishment with respect to compliance with these regulations.
4.3 No prior clearance from BFAD is required for initial printing and broadcast or dissemination of advertisement and other promotional materials for drug products.
4.4 BFAD shall monitor advertisement and promotion of drug products as well as receive complaints regarding these. On the basis of its monitored finding or complaints, BFAD shall determine if any advertising or promotional material violates these guidelines.
4.5 Any advertising or promotional material found to be violative of these guidelines will be identified and the drug establishment responsible shall be notified. BFAD shall issue a cease and desist order stopping the further release, printing, broadcast or dissemination of the violative advertising or promotional material.
4.6 If the drug establishment wishes to contest BFAD’s findings, a formal hearing shall be conducted. From the finding after the hearing, BFAD shall decide along the following possibilities:
4.6.1 The initial finding was found untenable and the cease and desist order is then lifted.
4.6.2 The initial finding was found valid so the cease and desist order remains.
4.7 Repeated or serious violations of these guidelines may be regarded by BFAD as indicative of the subject drug establishment’s inability to perform adequately in a manner that assures the proper use of its drug product. Under such condition and after due hearing, BFAD may impose the following sanctions:
4.7.1 Withdrawal by BFAD of accreditation of the establishment’s medical director.
4.7.2 Suspension of the license to operate of the drug establishments.
4.7.3 Cancellation of the certification of product registration.
4.7.4 Revocation of the license to operate of the drug establishment.
SECTION 5.0 Separability Clause
In case any provision of this A.O. is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect.
SECTION 6.0 Repealing Clause
All administrative orders, rules and regulations and other administrative issuances or parts thereof inconsistent with the provisions of this A.O. are hereby repealed or modified accordingly.
SECTION 7.0 Effectivity
This A.O. shall take effect fifteen days after its publication in two newspapers of general circulation.
(Sgd) ALFREDO R.A. BENGZON