Law Summary
Policy Declaration
- The State declares its policy to protect and promote public health through effective regulation of health products.
- Emphasizes enhancing regulatory capacity for inspection, licensing, and monitoring of establishments and health products.
Objectives of the Act
- Enhance and strengthen the FDA's administrative and technical capacities.
- Ensure comprehensive monitoring and regulation of establishments and products.
- Provide coherence in regulatory systems covering establishments and products.
Functions, Powers, and Duties of the FDA
- Administer and enforce the Act and its rules.
- Primary jurisdiction over sampling health products.
- Analyze and inspect health products.
- Establish standards for health product identity, purity, safety, efficacy, quality, and packaging.
- Issue certificates of technical compliance and conduct spot-check inspections.
- Conduct product testing before authorization to ensure safety and efficacy.
- Require reporting of incidents indicating harm caused by health products.
- Issue cease and desist orders; ban, recall, or withdraw harmful products after due process.
- Strengthen post-market surveillance and monitor adverse events.
- Develop standards and authorize establishments and products.
- Oversee research studies related to health product safety.
- Regulate advertising and marketing related to health products.
- Maintain bonded warehouses for confiscated goods.
- Exercise additional powers as necessary to fulfill its mandate.
Organizational Structure of the FDA
- Establishment of four major Centers categorized by product: Drug, Food, Cosmetics, Device/Radiation Health.
- Each Center includes divisions for Licensing and Registration, Product Research and Standards Development, and Laboratory Support.
- Additional offices: Administration and Finance Office, Policy and Planning Office, Field Regulatory Operations Office, and Legal Services Support Center.
Leadership and Appointment
- FDA headed by a Director-General (undersecretary rank) appointed by the President.
- Assisted by two Deputy Directors-General for Administration/Finance and Field Regulatory Operations.
- Qualifications for leadership roles include relevant degrees, management experience, and disclosures to prevent conflicts of interest.
- Directors of Centers and Field Offices appointed by the Secretary of Health.
Staffing and Staffing Pattern
- FDA reviews staffing and position titles subject to Secretary of Health approval.
Key Definitions
- Comprehensive definitions covering terms like FDA, food, drug, device (medical, radiation, health-related), cosmetics, labeling, manufacturer, distributor, retailer, veterinary drugs, household hazardous substances, licensing, registration, misbranding, and health products in general.
Prohibited Acts
- Manufacture, import, export, sale, distribution, or promotion of adulterated, unregistered, or misbranded health products.
- Prohibiting false guarantees and alterations affecting product labeling.
- Operating without the required FDA license.
- Selling health products beyond expiry.
Penalties for Violations
- Imprisonment from 1 to 10 years and fines ranging from P50,000 to P500,000, increased for manufacturers/importers/distributors.
- Additional fines for continuing violations.
- Penalties extend to responsible corporate officers.
- Deportation for foreign nationals who violate the Act.
Administrative Procedures
- FDA conducts hearings on violations.
- Opportunities for parties to be heard before FDA decisions.
- Both criminal and administrative actions may be pursued independently.
Administrative Sanctions
- Cancellation or suspension of FDA authorizations.
- Fines from P50,000 to P500,000 with additional fines for ongoing violations.
- Product destruction and establishment closure.
Additional Powers of the Director-General
- Hold persons in contempt for disregarding FDA orders.
- Administer oaths, issue subpoenas for investigations.
- Acquire information from government units.
- Issue seizure orders for violative articles pending hearings.
- Deputize law enforcement agencies for implementation.
Appeal Processes
- FDA decisions are final and executory after 15 days unless an administrative appeal is filed.
- Appeals may be made to the Secretary of Health upon filing notice and bond.
- Appeals do not automatically stay FDA decisions unless ordered.
Fee Structure and Income Retention
- Annual fees determined and reviewed by the FDA with Secretary approval.
- Extra regulatory fees include fines, penalties, and service charges.
- FDA authorized to retain income as a special regulatory fund used primarily for infrastructure, human resources, equipment, and maintenance.
- Fund can accept grants and donations; cannot be reallocated without COA rules.
- Legal fund established from interest for defending FDA officials/employees.
Regulatory Enforcement Unit (REU)
- Established for five years to enforce FDA regulations at the regional level with armed, uniformed personnel.
- REU officers serve and execute FDA orders and warrants.
- Unit led by lawyer Division Director and assistant.
- Law enforcement authority limited to FDA regulatory functions.
Testing Laboratories and Field Offices
- Establish at least one testing laboratory each in Luzon, Visayas, and Mindanao with state-of-the-art equipment.
- Existing labs in Cebu and Davao upgraded; new lab in Subic established.
- Authority to accredit and call on other government/private labs for testing.
- FDA field offices established nationwide, bringing regional food and drug officers under the FDA.
- Field offices composed of licensing/inspection, satellite labs, and administrative divisions.
Expansion and Organizational Units
- FDA may create new units as necessary to meet emerging health concerns and international standards.
- Additional plantilla positions may be created subject to existing rules.
Appropriations and Budget
- Existing DOH budget for BFAD and BHDT used for implementation.
- FDA income may augment appropriations.
- Subsequent funding included in General Appropriations Act.
Implementing Rules and Regulations
- DOH to promulgate implementing rules within 120 days after enactment.
Congressional Oversight
- Oversight Committee formed with members from relevant Congressional committees to monitor FDA implementation and income use for five years.
Transitory Provisions
- Current BFAD and BHDT officials and employees transferred to FDA with no loss of rank or benefits.
- All assets, powers, functions, and funds transferred accordingly.
Coverage and Exclusive Jurisdiction
- Act governs all health products but does not affect exclusive jurisdiction of other specialized agencies and laws in specific areas.
Separability Clause
- Invalidity of any provision does not affect the remainder of the Act.
Repealing and Effectivity Clauses
- Laws and issuances inconsistent with the Act are repealed or amended.
- Act takes effect 15 days after publication in the Official Gazette or two newspapers of general circulation.