Law Summary: Republic Act No. 9711

Republic Act No. 9711, also known as the Food and Drug Administration (FDA) Act of 2009, was enacted to strengthen the regulatory capacity of the Bureau of Food and Drugs (BFAD) by renaming it to the Food and Drug Administration (FDA). The Act aims to protect and promote the right to health of the Filipino people by ensuring the safety, efficacy, and quality of health products available in the market.

The FDA Act of 2009 outlines several key objectives. First, it seeks to enhance the administrative and technical capacity of the FDA in regulating establishments and products under its jurisdiction. Second, it aims to ensure comprehensive monitoring and regulatory coverage over these establishments and products. Third, it intends to provide coherence in the FDA’s regulatory system, ensuring that all relevant establishments and products are systematically and consistently regulated.

The Act establishes several centers within the FDA, each responsible for a major product category: the Center for Drug Regulation and Research, the Center for Food Regulation and Research, the Center for Cosmetics Regulation and Research, and the Center for Device Regulation, Radiation Health, and Research. These centers are tasked with regulating the manufacture, importation, exportation, distribution, sale, and promotion of health products. They are also responsible for conducting research on the safety, efficacy, and quality of health products and establishing standards for the same.

The FDA Act also provides the Director-General with significant powers to ensure compliance with the law. These include the power to issue cease and desist orders, seize and hold products, call upon law enforcement agencies for assistance, and impose administrative sanctions such as fines and suspension or cancellation of licenses. The Director-General is also authorized to establish testing laboratories and field offices across the country to support the FDA’s regulatory functions.

Additionally, the Act includes provisions for the collection of fees and other income to fund FDA operations, the establishment of a Regulatory Enforcement Unit (REU), and the creation of a Congressional Oversight Committee to monitor the implementation of the Act. The FDA is also empowered to accept grants, donations, and other endowments, subject to relevant laws and regulations.

In summary, Republic Act No. 9711 is a comprehensive legislation aimed at ensuring the safety, efficacy, and quality of health products in the Philippines. By strengthening the regulatory capacity of the FDA, the Act seeks to protect public health and maintain an effective health products regulatory system responsive to the country’s needs.