Question & AnswerQ&A (Republic Act No. 9711)
The Bureau of Food and Drugs (BFAD) is renamed the Food and Drug Administration (FDA).
The State declares a policy 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 objectives are to enhance and strengthen the administrative and technical capacity of the FDA, ensure comprehensive regulatory coverage of establishments and products under its jurisdiction, and provide coherence in FDA's regulatory system.
Key functions include administering implementation of the Act, primary jurisdiction in sample collection, analyzing and inspecting health products, issuing certificates of compliance, conducting tests before authorizations, issuing cease and desist orders, banning or recalling harmful products, developing standards, and overseeing regulatory enforcement.
The four centers are: (1) Center for Drug Regulation and Research (includes veterinary medicine, vaccines, biologicals), (2) Center for Food Regulation and Research, (3) Center for Cosmetics Regulation and Research (includes household hazardous/urban substances), (4) Center for Device Regulation, Radiation Health, and Research.
The FDA is headed by a Director-General with the rank of Undersecretary, preferably possessing a degree in medicine or a relevant master's degree in pharmaceutical or allied sciences, or an equivalent executive course, with management experience in development, manufacturing, regulatory work, or quality assurance of products.
Prohibited acts include manufacturing, importing, selling, distributing, promoting any adulterated, unregistered, or misbranded health products; adulteration or misbranding of health products; false guaranties; removal or alteration of labeling leading to adulteration or misbranding; conducting operations without necessary licenses; and selling health products beyond their expiry dates.
Penalties include imprisonment from one to ten years, fines ranging from fifty thousand pesos to five million pesos depending on the offender's role, and additional daily fines. Juridical persons’ officials and foreign nationals face penalties and deportation.
The FDA can cancel or suspend authorizations, impose fines up to five hundred thousand pesos plus additional daily fines, order destruction or proper disposition of offending products, and close establishments.
The Director-General can hold persons in contempt, administer oaths, issue subpoenas, obtain information from government entities, order seizure of offending products, call on other agencies for assistance, and deputize law enforcement officers for effective enforcement.
FDA decisions become final after 15 days of receipt unless an administrative appeal is filed. One motion for reconsideration may be filed suspending the period. Appeals are made to the Secretary of Health and require posting an appeal bond. Appeals do not automatically stay execution unless ordered.
Health products include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, household/urban hazardous substances, and any related products or derivatives thereof requiring regulation as determined by the FDA.
Devices include medical devices (instruments, machines, apparatus for diagnosis, treatment, etc. not primarily acting by pharmacological means), radiation devices (electrical or electronic apparatus emitting radiation), and health-related devices that negatively affect health though not directly used in healthcare.
A 'drug' means articles recognized in official pharmacopeias, articles intended for diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals, articles meant to affect body structure or function, excluding devices or their parts.
The FDA must establish testing laboratories in Luzon, Visayas, and Mindanao with state-of-the-art equipment; maintain and upgrade existing labs; may accredit private labs; and establish field offices in all regions. Field offices manage licensing, inspection, satellite labs, and administrative functions to strengthen regulatory enforcement.
Yes, the FDA can retain income deposited in a special regulatory fund used primarily for office and laboratory expansions, equipment purchases, human resource development, and operations. The fund is subjected to COA rules but not to executive orders modifying purpose and may accept grants or donations.
The REU consists of qualified personnel who bear arms, wear uniforms, serve FDA orders, execute search and arrest warrants related to health product regulation violations, and are law enforcement agents with authority limited to FDA regulatory functions.