AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES

Case Overview and Summary

Summary of Republic Act No. 9711 (FDA Act of 2009)

Establishment and Renaming
- The Bureau of Food and Drugs (BFAD) is renamed as the Food and Drug Administration (FDA). (Section 1)
- The FDA is an office under the Department of Health. (Section 5)

Policy and Objectives
- Declares the policy to protect public health and establish an effective regulatory system for health products. (Section 3)
- Objectives include enhancing FDA's regulatory capacity, monitoring coverage, and coherence in regulation. (Section 4)

Functions and Powers of FDA
- Administer implementation of the law and regulations. (Section 5(a))
- Assume jurisdiction over collection of health product samples. (Section 5(b))
- Analyze, inspect, and establish standards for health products. (Sections 5(c), 5(d), 5(h))
- Issue certificates of compliance and authorizations. (Section 5(e))
- Conduct tests on health products prior to authorization. (Section 5(h))
- Require reporting of adverse events related to health products. (Section 5(i))
- Issue cease and desist orders and order recalls of harmful products. (Sections 5(j), 5(k))
- Strengthen post-market surveillance. (Section 5(l))
- Develop standards and authorizations for establishments and products. (Section 5(m))
- Regulate advertising and promotion of health products. (Section 5(o))
- Maintain bonded warehouses for confiscated goods. (Section 5(p))

Centers and Offices within FDA
- Establish centers for drug, food, cosmetics, and device regulation. (Section 6(a))
- Each center to have divisions for licensing, research, and laboratory support. (Section 6(b))
- Establish Administration and Finance, Policy and Planning, Field Regulatory Operations, and Legal Services offices. (Sections 6(c), 6(d), 6(e), 6(f))

Leadership and Personnel
- FDA headed by a Director-General with the rank of Undersecretary. (Section 7(a))
- Two Deputy Directors-General for Administration/Finance and Field Operations. (Section 7(b))
- Qualifications and restrictions for Director-General and Deputies. (Sections 7(d), 7(e), 7(f), 7(g))
- Centers and field offices headed by Directors and Assistant Directors. (Section 7(h))
- FDA to review staffing pattern and position titles. (Section 8)

Prohibited Acts and Penalties
- Prohibits manufacture, import, sale, etc. of adulterated, unregistered, or misbranded health products. (Section 11(a), 11(b))
- Prohibits false guarantees, altering labels, operating without license, etc. (Sections 11(d), 11(g), 11(k))
- Penalties of 1-10 years imprisonment and/or P50,000-P500,000 fine. (Section 12(a))
- Higher penalties of 5-10 years and P500,000-P5,000,000 for manufacturers, importers, distributors. (Section 12(a))
- Additional 1% of product value per day of violation. (Section 12(a))
- Deportation for foreign nationals. (Section 12)

Administrative Sanctions
- FDA may cancel authorizations, impose fines of P50,000-P500,000, destroy products, or close establishments. (Section 29-A)

Additional Powers of Director-General
- Hold persons in contempt and impose penalties. (Section 30(1))
- Issue subpoenas and obtain information from government agencies. (Sections 30(2), 30(3))
- Seize adulterated or misbranded products. (Section 30(4))
- Call assistance from law enforcement agencies. (Section 30(5))

Appeals Process
- FDA orders become final after 15 days unless appealed. (Section 31)
- Appeals go to the Secretary of Health. (Section 32)

Fees and Income
- FDA to determine and review authorization fees annually. (Section 34(a))
- Establish "other related regulatory fees" for services, fines, etc. (Section 34(b))
- Retain income in a special regulatory fund for operations and improvements. (Section 18)

Testing Laboratories and Field Offices
- Establish testing labs in Luzon, Visayas, and Mindanao with state-of-the-art equipment. (Section 35)
- Upgrade existing labs in Cebu and Davao; establish new lab in Subic. (Section 35)
- Establish field offices in all regions for inspection and compliance. (Section 36)
- Create additional organizational units as needed. (Section 37)

Coverage and Exclusions
- Covers all health products: food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostics, and household hazardous substances. (Section 10)
- Does not modify jurisdiction of other specialized agencies under certain laws. (Section 25)

Definitions (Section 10)
- Defines "health products", "food", "drug", "device", "cosmetics", "label", and other key terms.
- Specifies types of devices: medical devices, radiation devices, health-related devices.
- Defines "manufacturer", "distributor", "importer", "exporter", "wholesaler", "retailer", "trader".
- Defines "assay", "authorization", "bioavailability", "bioequivalence", "establishment".