CASE DIGEST: Republic vs. Bureau of Food (now FDA)

G.R. No. 190837 March 5, 2014




The FDA was created pursuant to Republic Act No. (RA) 3720, otherwise known as the "Food, Drug, and Cosmetic Act," primarily in order to establish safety or efficacy standards and quality measures for foods, drugs and devices, and cosmetic products. On March 15, 1989, DOH issued Administrative Order No. 67 entitled Revised Rules and Regulations of Pharmaceutical Products. It required drug manufacturers to register certain drug and medicine with the FDA before they may be released to the market for sale. It also required a bioavailability/ bioequivalence (BA/BE) test for a manufacturer to secure a Certificate of Product Registration (CPR) for its products. The implementation of the BA/BE test however was put on hold because there was no facility capable of conducting the same. FDA then issued Circular 1 which resumed the implementation of the BA/BE test. Thereafter, FDA issued Circular 8 which provided for additional details concerning the test requirement.

Respondent is a drug manufacturer of a drug brand named Refam for the treatment of persons suffering from pulmonary and extra- pulmonary tuberculosis. When Refam was subjected to the required test, it resulted that the product was not a bioequivalent with the reference drug. FDA warned respondent that is CPR will never be renewed unless it submit satisfactory results of BA/BE test.

Instead of submitting satisfactory BA/BE test results for Refam, respondents filed a petition for prohibition and annulment of Circular Nos. 1 and 8, s. 1997 before the RTC, alleging that it is the DOH, and not the FDA, which was granted the authority to issue and implement rules concerning RA 3720. As such, the issuance of the aforesaid circulars and the manner of their promulgation contravened the law and the Constitution. They further averred that that the non-renewal of the CPR due to failure to submit satisfactory BA/BE test results would not only affect Refam, but their other products as well.

ISSUE: Whether or not the FDA may validly issue and implement Circular Nos. 1 and 8, s. 1997


Political Law- An administrative regulation that is merely an interpretative rule needs nothing further than its issuance

An administrative regulation may be classified as a legislative rule, an interpretative rule, or a contingent rule. Legislative rules are in the nature of subordinate legislation and designed to implement a primary legislation by providing the details thereof. They usually implement existing law, imposing general, extra-statutory obligations pursuant to authority properly delegated by Congressand effect a change in existing law or policy which affects individual rights and obligations.

Meanwhile, interpretative rules are intended to interpret, clarify or explain existing statutory regulations under which the administrative body operates. Their purpose or objective is merely to construe the statute being administered and purport to do no more than interpret the statute. Simply, they try to say what the statute means and refer to no single person or party in particular but concern all those belonging to the same class which may be covered by the said rules.Finally, contingent rules are those issued by an administrative authority based on the existence of certain facts or things upon which the enforcement of the law depends.

In general, an administrative regulation needs to comply with the requirements laid down by Executive Order No. 292, s. 1987, otherwise known as the "Administrative Code of 1987," on prior notice, hearing, and publication in order to be valid and binding, except when the same is merely an interpretative rule. This is because when an administrative rule is merely interpretative in nature, its applicability needs nothing further than its bare issuance, for it gives no real consequence more than what the law itself has already prescribed.

A careful scrutiny of the foregoing issuances would reveal that AO 67, s. 1989 is actually the rule that originally introduced the BA/BE testing requirement as a component of applications for the issuance of CPRs covering certain pharmaceutical products. As such, it is considered an administrative regulation a legislative rule to be exact issued by the Secretary of Health in consonance with the express authority granted to him by RA 3720 to implement the statutory mandate that all drugs and devices should first be registered with the FDA prior to their manufacture and sale. Considering that neither party contested the validity of its issuance, the Court deems that AO 67, s. 1989 complied with the requirements of prior hearing, notice, and publication pursuant to the presumption of regularity accorded to the government in the exercise of its official duties.

The FDA then issued Circular No. 8, s. 1997 to supplement Circular No. 1, s. 1997 in that it reiterates the importance of the BA/BE testing requirement originally provided for by AO 67, s. 1989. Circular Nos. 1 and 8, s. 1997 cannot be considered as administrative regulations because they do not: (a) implement a primary legislation by providing the details thereof; (b) interpret, clarify, or explain existing statutory regulations under which the FDA operates; and/or (c) ascertain the existence of certain facts or things upon which the enforcement of RA 3720 depends. In fact, the only purpose of these circulars is for the FDA to administer and supervise the implementation of the provisions of AO 67, s. 1989, including those covering the BA/BE testing requirement, consistent with and pursuant to RA 3720. Therefore, the FDA has sufficient authority to issue the said circulars and since they would not affect the substantive rights of the parties that they seek to govern as they are not, strictly speaking, administrative regulations in the first place no prior hearing, consultation, and publication are needed for their validity.