Republic Act . No. 9711August 18, 2009

AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BFAD BY

ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT,

AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING

IT AS FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF RA No. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF”

Salient Features of the Law

• BFAD is renamed as Food and Drug Administration (FDA)

• FDA shall be under the office of the Secretary of Health

• Duties and responsibilities of the FDA was increased/ emphasized

• Definition of terms and punishable acts modified, penalties increased

Definition of Terms

Food

Drug

Device - Medical device, radiation device, health-related device

Cosmetics

Label

Distribute

Manufacture

Definition…

Veterinary drugs

Assay

Bioavailability

Bioequivalence (n)

Distributor/importer/exporter (n)

Distributor/wholesaler (n)

Establishment (n)

Definition…

Food/dietary supplement (n)

Health products (n)

Household/ urban hazardous substances (n)

In-vitro diagnostic reagents (n)

Licensing (n)

Misbranding

Salient…

• Headed by a director general having the rank of an undersecretary , aided by 2 deputy director generals

• Merging of BFAD and BHDT

• Current BFAD director to head the FDA

• Current BHDT director as one of the deputy DG.

Salient…

4 Centers , each to be headed by a director

• Center for DRUG regulation and research

• Center for FOOD regulation and research

• Center for COSMETICS regulations and research

• Center for DEVICE regulations, radiation health and research

Salient…

Each center will have the following divisions • Licensing and registration division• Product research and standards development

division• Laboratory support division• Administrative and finance office• Policy and planning office

Salient….

• Existing directors of BHDT & division chiefs of BFAD- given preference for appointment as directors & assistant directors of their respective centers (3 years to acquire 3rd level CS eligibility)

• FDA staffing pattern to be approved by the SOH

Salient…

• Definition of terms – revised, added terms

• Punishable acts (Sec. 11) amended

• Provision of funds for legal assistance to FDA personnel in the exercise of their duties

• Cebu & Davao Satellite laboratories + 1 in Subic, Zambales

Salient…

• Penalties – increased

1- 10 years imprisonment +

Fine- 50K to 500K

5-10 years imprisonment +

Fine of 500K to 5 M

Salient…

• Establishment of a Regulatory Enforcement Unit (REU) – for a period not exceeding 5 years from the effectivity of the Act

• Composed of at least 5 personnel per region

• Headed by a lawyer (rank of a Division Director) & an assistant (at least law graduate, w/ the rank of Assistant Division Director)

Salient…Under the Deputy DG for Field Regulatory

operations & administratively supported by the field offices• Bear arms, wear official uniforms & insignias

& shall be classified as law enforcement agents

• Serve & execute ruling, orders & decisions of the DG

• Execute & serve search warrants & arrest warrants

• Undergo appropriate training

Transitory Provisions

• Current officials & employees of BFAD- transferred as far as practicable to the appropriate unit in the FDA as determined by the DG

• Current BHDT officials & employees shall be transferred to the Center for Device Regulation, Radiation Health, and Research

Transitory…

• Current regional FDROs & regional health physicists shall be transferred to the appropriate unit in the FDA as determined by the DG

• No demotion in ranks & positions

• No diminution in salaries, benefits, allowances & emoluments

Transitory…

• All positions, powers, functions & duties together with the facilities, equipment, supplies, records , files, appropriations, and funds for these bureaus & the CHD personnel shall be transferred to the FDA.