History

In the light of the tremendous progress in the food and pharmaceutical industry, the late Department of Health (DOH) Secretary Francisco Duque Sr. created a subcommittee on Food and Drugs in the year 1961-62 to initiate an administration bill to Congress to enact a law that would ensure the safety, purity and quality of foods, drugs and cosmetics being made available to the public. The Subcommittee on Food and Drug was chaired by the then Undersecretary for Special Health Services, Dr. Rodolfo Caños, with members Dr. Trinidad Pesigan, Director of the Bureau of Research and Laboratories, Mr. Emilio Espinosa of the Bureau of Health Services, Ms. Amor Cita M. Pallera, Pharmacy Adviser, Office of the Secretary of Health, also as Secretary and Liaison to Congress. Thus, on June 22, 1963 Republic Act No. 3720 was passed into law known as the “Food, Drug and Cosmetic Act”.

Mandate

As a regulatory agency under the Department of Health, the Food and Drug Administration, created under Republic Act No. 3720, series of 1963, as amended by Executive Order 175, series of 1987, otherwise known as the “Food, Drugs and Devices, and Cosmetics Act”, and subsequently Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”, is mandated to ensure the safety, efficacy or quality of health products as defined by RA No. 97111, which include means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health which require regulations as determined by the FDA.

Among others, the FDA is also mandated to enforce the provisions of the following laws:

  • RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008, 
  • RA 6675, or  The Generics Act Of 1988, 
  • RA 5921, or The Pharmacy Law,
  • RA 9211, or The Tobacco Regulation Act of 2003
  • RA 7394, or The Consumer Act of the Philippines
  • RA 7581/10623, or The Price Act
  • RA 10611, or The Food Safety Act of 2013
  • RA  8172, or The ASIN Law,
  • RA 8203, or The Special Law on Counterfeit Drug
  • RA 8976, or The Food Fortification Law
  • RA 9165, or The Comprehensive Dangerous Drugs Act
  • RA 9257, or The Expanded Senior Citizens Act of 2003
  • PD No. 881, or The Household Hazardous Act
  • EO No. 51, or The Milk Code of the Philippines
  • RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 2012
  • PD 856, or The Code of Sanitation of the Philippines

Functions

In order to protect and promote the right to health of the Filipino people and to establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems, the FDA shall perform the following functions as provided by existing laws:

  • To establish safety or efficacy standards and quality measures for foods, drugs and devices and cosmetics and other health product;
  • To undertake appropriate health manpower development and research, responsive to the country's health needs and problems;
  • To assume primary jurisdiction in the collection of samples of health products;
  • To analyze and inspect health products;
  • To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;
  • To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA
  • To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality;
  • To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person;
  • To issue cease and desist orders motu propio or upon verified complaint for health produts, whether or not registered with the FDA Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed;
  • To order the ban, recall, and/or withdrawal of any health product, after due process, found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization;
  • To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products;
  • To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products;
  • To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA;
  • To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products
  • To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and
  • To exercise such other powers and perform such other functions as may be necessary to carry out its duties and responsibilities.

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