SEC. 13. Section 29-A of Republic Act No. 3720, as amended, is hereby further amended, and new subsections are added to read as follows:
“SEC. 29-A. Administrative Sanctions. Where there is finding of prohibited actions and determination of the persons liable thereto, after notice and hearing, the director-general is empowered to impose one or more of the following administrative penalties:
“(1) Cancellation of any authorization which may have been granted by the FDA, or suspension of the validity thereof for such period of time as the director-general may deem reasonable which shall not exceed one (1) year;
“(2) A fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00). An additional fme of not more than One thousand pesos (Pl,000.00) shall be imposed for each day of continuing violation; and
“(3) Destruction and/or appropriate disposition of the subject health product and/or closure of the establishment for any viollition of this Act, as determined by the director-general.”
SEC. 14. A new Sectio.n 30 and a new headnote “Additional Powers and Functions of the Director-General are hereby added to Republic Act No. 3720, which shall read as follows:
“SEC. 30. The Director-General shall also exercise the following powers:
“(1) To hold in direct or indirect contempt any person who disregards orders or writs he or she issues and impose the appropriate penalties following the same procedures and penalties provided in the Rules of Court;
“(2) To administer oaths and affirmations and issue subpoena duces tecum and subpoena ad testificandum requiring the production of such books, contracts, correspondence, records, statement of accounts and other documents and/or the attendance and testimony of parties and witnesses as may be material to the investigation conducted by the FDA;
“(3) To obtain information from any officer or office of the national or local governments, government agencies and its instrumentalities;
“(4) To iSime orders of seizure, to seize and hold in custody any article or articles of food, device, cosmetics. household hazardous substances and health products that is adulterated, counterfeited, misbranded or unregistered, or drug, in-vitro diagnostic reagent, biologicals, and vaccine that is adulterated or misbranded, when introduced into domestic commerce pending the authorized hearing under Republic Act No. 3720, as amended, Executive Order No. 175 (1987), and Republic Act No. 7394, otherwise known as the Consumers Act of the Philippines;
“(5) To call on the assistance of any departme-p-t, office or agency and deputize members of the Philippine National Police or any law enforcement agency for the effective implementation of this Act; and
“(6) To exercise such powers and functions as may be necessary for the effective implementation of this Act.”
SEC. 15. Two new sections shall be added, which shall be the new Sections 31 and 32 of Republic Act No. 3720, as amended, which shall read as follows:
“SEC. 31. The orders, rulings or decisions of the FDA shall become final and executory fifteen (15) days after the receipt of a copy thereof by the party adversely affected unless within that period, an administrative appeal has been perfected. One motion for reconsideration may be filed, which shall suspend the running of the said period.”
“SEC. 32. The orders, rulings or decisions of the FDA shall be appealable to the Secretary of Health. An appeal shall be deemed perfected upon filing of the notice of appeal and posting of the corresponding appeal bond.
“An appeal shall not stay the decision appealed from unless an order from the Secretary of Health is issued to stay the execution thereof.”
SEC. 16. SEC. 16. Section 30 of Republic Act No. 3720, as amended, shall be renumbered as Section 33 and the subsequent section shall also be renumbered accordingly.
SEC. 17. Section 31, Chapter XIII of Republic Act No. 3720, as amended,’ is hereby further amended to read as follows:
“SEC. 34. Fees and Other Income. –
“(a) Upon the sole approval of the Secretary, the authorization and other fees shall annually be determined and reviewed by the FDA and any proposed increase shall be published in two (2) leading newspapers of general circulation.
.”(b) There shall be determined and constituted additional fees such as sale of publications and services, assessment fees, fines, penalties, and other fee and charges outside the usual licensing and registration fees, to be ‘known as ‘other related regulatory fees’.
“(c) The Director-General of the FDA, upon approval of the Secretary, shall be authorized to promulgate rules and regulations governing the collection of the other related regulatory fees. Upon approval of the Secretary, these fees shall likewise be reviewed periodically and any proposed increase shall be published in two (2) leading newspapers of general circulation.”
SEC. 18. All income that the FDA is allowed to retain under Section 31 of the Universally Accessible Cheaper and Quality Medicines Act of 2008 shall, any provision of law to the contrary notwithstanding, be deposited in an authorized government depository bank as a special regulatory fund. Any interest earned by such fund shall form part of the retained income. Such fund shall be used primarily for the acquisition of office. and laboratory space, human resource development and expanSIOn, purchase of laboratory equipment and motor vehicles, the upgrading of its current facilities and equipment and maintenance, other operating expenses of the’ central office laboratory divisions and satellite laboratories in Davao, Cebu and other testing laboratories, in case the above laboratories will be increased, and other activities or services of the agency in the performance of its mandate.
The fund shall be allowed to accept grants, donations and all other endowments from lo’cal and external sources in accordance with pertinent laws, rules and regulations.
The retention, use and application of this fund shall not be delayed, amended, altered or modified, or affected in any way by an order or directive from any executive office, but will be subject only to the general accounting rules and guidelines by the Commission on Audit (COA). The primary purpose of the fund as herein stated shall prevail over any other purpose that may be pursued by the FDA on its own initiative or through an order or directive by any higher office. The FDA shall submit to the Secretary of Health, the Secretary of Budget and Management and the Congressional Oversight Committee, created under Section 23 of this Act, a report on how the funds were utilized, including its accomplishments.
There shall also be established a legal fund out of the interest earned from the retained income for use in case of legal actions against the officials and employees of the FDA in the course of the exercise of their official functions and duties.
SEC. 19. The FDA shall establish a Regulatory Enforcement Unit (RED) for a period not exceeding five (5) years from the effectivity of this Act. It shall be composed of at least five (5) qualified personnel in every region who shall bemectly under the control and supervision of the Deputy Director-General for Field Regulatory Operations and shall be administratively supported by the field offices. They shall:
(a) Bear arms, wear official uniforms and insignias and shall be classified as law enforcement agents;
(b) Serve and execute rulings, orders, and decisions of the Director-General of the FDA; and
(c) Execute and serve search warrants and arrest warrants issued by the courts in connection with violations under this Act and related laws concerning the regulation of health products.
All law enforcement agents shall undergo the appropriate training to equip them with the necessary skills needed for this purpose. Their authority and functions shall be strictly limited to the Implementation of the FDA’s regulatory functions.
All regional regulatory enforcement units shall be headed by a lawyer who is at least thirty (30) years old but not older than fifty (50), an Integrated Bar of the Philippines (IBP) member of good standing, and shall have a rank of a Division Director; and an assistant who must be at the very least a law graduate who shall have a rank of an Assistant Division Director.
SEC. 20. A new chapter XIV and three new sections Sections 35, 36, and 37 shall be introduced, which shall read as follows:
CHAPTER XIV
TESTING LABORATORIES AND FIELD OFFICES
“SEC. 35. The FDA is hereby mandated to lillprove, upgrade and. increase the capability of the agency, to test, calibrate, assay and examine samples of health products. For the purpose of achieving the above mandate, there shall be established at least one (1) testing laboratory each in Luzon, Vlsayas and Mindanao, which shall have the necessary and appropriate state-of-the-art laboratory equipment and personnel complement. The main testing laboratories at the central office shall be maintained and shall serve as a support unit to the centers for product research and evaluation and standards development and shall serve as testrng centers that would include assay and the conduct, supervision, oversight and/or audit of bioequivalence and bioavailability test/researches, among others. The existing laboratories in Cebu and Davao will be upgraded and transformed as quality assurance laboratories, while another one will be established in Subic, Zambales.
“The testing laboratoties may be increased by the -director-general, lipan approval of the Secretary. Moreover, the director-general, upon approval of the Secretary, may call upon other government and private testing laboratories to conduct testing, calibration, assay and examination of samples of health products: Provided, That the private testing laboratories are accredited by the Philippine Accreditation Office (PAO) of the Department of rrrade and industry (DTI) and the DOH.”
“SEC. 36. The FDA shall establish field offices in all regions of the country to effectively implement its regulatory functions. The CUI’rent regional food and drug regulatory officers and regional health physicists in every regional office of the DOH shall now be put under the FDA’s sale control and supervision. The regional field office shall also assume primary jurisdiction in the collection of sample food, drugs, devices and cosmetics being imported or offered for import at a port of entry other than Manila in hislher assigned region and where it appears that said items or products satisfy any of the conditions as provided for in Section 33(a) of R~public Act No. 3720, as amended, without prejudice to the exercise of the powers of the direetor”general provided under Sections 13 and 14 ofthis Act in the exercise of the agency’s regulatory functions. The field offices shall be comprised of the following: (a) licensing, inspection and compliance diyision, which shall have charge of the inspection of food, drugs and cosmetic establishments engaged intheil’p1artmacture, importation, distribution, and sale; (b) satellite laboratory division; and (c) administrative division.”
“SEC. 37. The FDA, with the approval of the Secretary, shall create organizational units which are deemed necessary to address emerging concerns and to be abreast with internationally acceptable standards. There shall be created additional plantilla positions to augment the human resource complement of the FDA, subject to existing rules and regulations.”
SEC. 21. Appropriations. – The appropriations for the BFAD and the BHDT included in the budget of the DOH under the current General Appropriations Act shall be used to carry out the implementation of this Act. The appropriation may be augmented by the income which the agency is authorized to use under this Act. Thereafter, such sums as may be necessary for its. continued implementation shall be included in the annual General Appropriations Act.
SEC. 22. Implementing Rules and Regulations. – The DOH shall promulgate, in consultation with the FDA, the implementing rules and :regUlations of this Act within one hundred twenty (120) dayt! after the passage of this Act.
SEC. 23. Congressional Oversight Committee. – A Congressional Oversight Committee (COC) is hereby created composed of the Chairpersons of the Committees on Health and Appropriations of the House of Representatives and two (2) Members to be appointed by the Speaker, the Chairpersons of the Committees on Health and Finance of the Senate and two (2) Members to be appointed by the President of the Senate, to oversee the implementation of this Act for a period of five (5) years and to review the accomplishments and the utilization of income of the FDA. The secretariat of the COC shall be drawn from the existing personnel of the committees comprising the COC.
SEC. 24. Transitory Provisions. – The BFAD Director and Deputy Director shall serve as FDA Director-General and Deputy Director-General for Field Regulatory Operations, respectively. The current officials and employees of the BFAD shall be transferred as far as practicable to the appropriate unit in the FDA as determined by the Director-General. The current officials and employees of the BHDT shall be transferred to the Center for Device Regulation, Radiation Health, and Research. The current regional food and drug regulatory officers and regional health physicists under the Centers for Health Development of the DOH shall be transferred as far as practicable to the appropriate unit in the FDA as determined by the Director-General. There shall be no demotion in ranks and positions and no diminution in salaries, benefits, allowances and emoluments of all BFAD, BHDT and indicated Center for Health and Development (CHD) personnel transferred to the FDA. All positions, powers, functions and duties together with the facilitieS, equipment, supplies, records, files, appropriations, and funds for these bureaus and the indicated CHD personnel shall be transferred to the FDA.
SEC. 25. Coverage. – This Act shall govern all health products: Provided, That nothing in this Act shall be deemed to modify the sole and exclusive jurisdiction of other specialized agencies and special laws only insofar as the acts covered by these specialized agencies and laws, including, but not limIted to those .covered by Republic Act No. 9211, Executive Order No, 245, Executive Order No. 18, and Presidential Decree No. 1468.
SEC. 26. Separability Clause. – If any part, section or provision of this Act shall be declared invalid or unconstitutional, other provisions or parts thereof which are not affected thereby shall remain in full force and effect.
SEC. 27. Repealing Cause. – Laws or part of laws executive orders, circulars, regulations and memoranda inconsistent with this Act are hereby repealed or amended accordingly.
SEC. 28. Effectivity Clause. – This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in two (2) newspapers of general circulation.
