FEB.

17, 2012 DATE

NR # 2682
REF. NO.

Solon hits failure to create Food and Drug Administration

After more than two years since it was enacted into law, Republic Act 9711 or the law creating the Food and Drug Administration (FDA) is yet to be fully implemented. This prompted Rep. Ferjenel Biron (4th District, Iloilo) to file House Resolution 2074 calling for the House Committee on Health to conduct an investigation why the law was not implemented. It has been two years and four months since the passage of the law on August 10, 2009, no concrete actions, initiatives or mechanisms have been done for the agencys full mandate implementation, Biron said. Biron said the Implementing Rules and Regulations (IRR) of the law were promulgated by the Department of Health (DOH) in consultation with the FDA only on 22 March 2011. Biron said the law was enacted to enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction and ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction. Likewise, Biron said the law will also provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction. It is a declared Policy under Section 3 of RA 9711 and Section 2 of its Implementing Rules and Regulations to enhance the FDAs monitoring capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments and registration and monitoring of health products which should have been attained by the full implementation of the law, Biron said. Under the law a Congressional Oversight Committee (COC) will be created composed of the Chairpersons of the Committees on Health and Appropriations of the House of Representatives and two Members to be appointed by the Speaker, the Chairpersons of the Committees on Health and Finance of the Senate and two Members to he appointed by the President of the Senate, to oversee the implementation of this Act for a period of five years and to review the accomplishments and the utilization of income of the FDA. Under the law, the FDA shall have a Center for Drug Regulation and Research, Center for Food Regulation and Research, Center for Cosmetics Regulation, and Research and Center for Device Regulation, Radiation Health, and Research. These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products. (30) jsc