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REPUBLIC v. DRUGMAKER’S LABORATORIES

FACTS:

The case involves a petition for review on certiorari filed by the Republic of the Philippines, represented by the Bureau of Food and Drugs (BFAD), against the Order of the Regional Trial Court (RTC) declaring BFAD Circular Nos. 1 and 8, series of 1997 null and void.

The petitioner challenges the authority of the FDA to issue and implement the circulars. The FDA was created to establish safety and quality standards for foods, drugs, and cosmetic products.

The circulars in question pertain to the bioavailability/bioequivalence (BA/BE) testing requirement for drug registration.

The respondents, Drugmaker's Laboratories, Inc. and Terramedic, Inc., manufacture a drug called Refam and applied for a Certificate of Product Registration (CPR) for the drug.

At the time of the CPR's issuance, the BA/BE testing requirement was put on hold due to the absence of local facilities capable of conducting such tests.

In 2001, when the BA/BE testing facilities were established, the FDA required the submission of satisfactory BA/BE test results for the renewal of the CPR.

Instead of submitting the test results, the respondents filed a petition before the RTC, arguing that the FDA's issuance of the circulars exceeded its authority.

The RTC ruled in favor of the respondents, declaring the circulars null and void and ordering the issuance of CPRs for the respondents' products.

The FDA appealed the RTC's decision to the Court, raising the issue of whether the FDA had the authority to issue and implement the circulars.

ISSUES:

  1. Whether the FDA may validly issue and implement Circular Nos. 1 and 8, s. 1997.

  2. Whether the assailed circulars complied with the requirements of a valid administrative rule.

RULING:

  1. The FDA has the authority to issue and implement Circular Nos. 1 and 8, s. 1997. The FDA is the agency mandated by law to administer and enforce rules and regulations pertaining to the registration of pharmaceutical products.

  2. The assailed circulars are valid administrative rules. While they were issued by the FDA and not the Secretary of Health, the power to make rules to implement RA 3720 is still within the authority of the FDA. Moreover, the circulars complied with the requirements of administrative rule-making as they were issued after consultation and publication.

PRINCIPLES:

  • The FDA has the authority to issue and implement rules and regulations concerning the registration of pharmaceutical products (citing RA 3720).

  • Administrative rules and regulations must comply with the requirements of law before they can be considered valid and enforceable.

  • The power to make rules to implement a law may be delegated to an agency or department granted such authority by law.