President Arroyo Tuesday signed a new law strengthening the regulatory capacity of the Bureau of Food and Drugs (BFAD) to ensure the safety, quality, and efficacy of medicines and other health products in the country.

Republic Act No. 9711 also renames BFAD as Food and Drug Administration (FDA) with improved administrative and technical capacity in the regulation of food, drugs, cosmetic, and device establishments and products.

The new law, otherwise known as the Food and Drug Administration Act of 2009, was signed in simple rites in Malacañang. Present in the signing ceremony were House Speaker Prospero Nograles, Sen. Juan Miguel Zubiri, Health Secretary Francisco Duque III, several lawmakers and
representatives from the medical field.

The new law also provides for the establishment of adequate testing laboratories, upgrading the agency’s equipment, augmentation of its human resources complement, and gives it authority to retain its income for its operations.

“The health sector has long been waiting for a stronger FDA. This is a dream come true. This has been the missing link in so far as the delivery and provision of quality medicines and health products is concerned,” Duque told reporters after the signing of the new law.

Duque said the FDA will also have four new centers on the regulation and research of drugs, food, cosmetics and devices to ensure their safety, efficacy, and quality. These products will be regulated by the FDA in terms of importation, export, manufacturing, distribution, advertising, and marketing.

He said FDA, an agency under the Department of Health, will have expanded powers, including the ability to ban, recall, and withdraw any health product that have caused death, serious illness or injury to a consumer.

He said the agency will also have the authority to conduct spot checks on establishments for compliance and issue cease-and-desist orders of products that fail safety standards. The agency will continue to assume the primary jurisdiction in the collection and inspection of samples of health products prior to the issuance of appropriate certificates.

The law also allowed the FDA to establish a Regulatory Enforcement Unit to serve executive rulings of the FDA as well as executive and serve search warrants and arrests. The law enforcement unit will run for a period of not exceeding five years upon the implementation of RA 9711.

Another salient feature of RA 9711 is allowing the FDA to keep its income from testing of products to upgrade their laboratories and other equipment, according to Duque.

Duque said a testing laboratory for health products will also established in Luzon, the Visayas and Mindanao to reduce processing time from the usual six to nine months to only three months or less.

The main testing laboratories at the central office will be maintained and will serve as support unit to the centers for product research and evaluation and standards development. The existing laboratories in Cebu and Davao will also be upgraded and transformed as quality assurance laboratories while another one will be established in Subic, Zambales.

The annual budget of FDA will be included in the budget of the DoH. For the smooth transition, the BFAD Director and Deputy Director shall serve as FDA Director General and Deputy Director General for Field Regulatory Operations, respectively.

The law takes effect 15 days after its publication in the Office Gazette or in two national newspapers.

Sen. Pilar Juliana “Pia” Cayetano welcomed the signing of RA 7911, saying this will enhance government’s efforts to make medicines not only affordable and accessible to the public but also guarantee their high quality, efficacy and safety.

The measure is also meant to complement Republic Act 9052 or the “Universally Accessible Cheaper and Quality Medicines Act of 2008.”

“Recently, we’ve had reports of counterfeit medicines and even fake flu vaccines being seized by authorities as well as incidents of imported milk, peanut butter and other food products tainted with chemicals unfit for human consumption. We hope to strengthen our first line of defense against fake drugs and unsafe products with the creation of the FDA,” Cayetano said.

With the signing of the law, former BFAD chief Leticia Barbara Gutierrez will be placed under the office of Department of Health (DoH) undersecretary Alexander Padilla as Special Assistant to the office of policy standards for regulatory cluster while former BFAD officer Nazarita Tacandong was appointed Acting Director of the agency.

In a phone interview, Gutierrez said, "We can serve better in terms of protecting public health. With more people, we can process more drug evaluation. Then there would be more registered products in the market and there is a possibility of better competition and drug prices will be lower.”

She said the Regulatory Enforcement Unit will be headed by a lawyer and personnel with experience in law enforcement.

"This will be headed by a lawyer and people probably with some experience in regulatory functions such as policemen and military personnel...(because) they will be armed," she said.

She said the regulatory enforcement unit will support the market monitoring surveillance unit that inspects outlets and facilities nationwide. She said the regulatory enforcement unit will protect the FDA inspectors against all forms of harassment.