G.R. No. L-82568 May 31, 1988
HON. ALFREDO R.A. BENGZON, in his capacity as Secretary of Health, HON. CATALINA C. SANCHEZ, in her capacity as the Director of Food and Drugs of the NATIONAL DRUG COMMITTEE of the Department of Health, petitioners, vs. COURT OF APPEALS and BOIE-TAKEDA CHEMICALS, INC., respondents.

FACTS

The Secretary of Health and the Director of the Bureau of Food and Drugs (BFAD) issued BFAD Regulation No. 1-A, which ordered the recall and banning from the market of pharmaceutical preparations containing oral anti-inflammatory proteolytic enzymes (OPE), including respondent Boie-Takeda Chemicals, Inc.’s drug “Danzen.” This regulation was based on a prior U.S. Food and Drug Administration decision, affirmed by a U.S. court, which found such enzymes not effective for their claimed uses. Boie-Takeda, which had been licensed to manufacture and sell Danzen in the Philippines since 1970, requested reconsideration, arguing that serrapeptase (the enzyme in Danzen) was never part of the U.S. review, that it is approved in many other countries, and that it had submitted voluminous clinical data to the BFAD demonstrating its efficacy.
Boie-Takeda filed a petition with the Court of Appeals, which issued a writ of preliminary injunction enjoining the enforcement of the BFAD regulation. The health officials then elevated the case to the Supreme Court via certiorari, seeking to annul the writ and arguing that the appellate court committed grave abuse of discretion in issuing it. They contended that the injunction interfered with their statutory duty to protect public health by ensuring the safety and efficacy of drugs.

ISSUE

Whether the Court of Appeals committed grave abuse of discretion in issuing the writ of preliminary injunction against the enforcement of BFAD Regulation No. 1-A.

RULING

The Supreme Court ruled that the Court of Appeals did not commit grave abuse of discretion. The legal logic centers on the nature and purpose of a preliminary injunction and the standard of judicial review. A writ of preliminary injunction is an ancillary remedy issued to preserve the rights of a party pending litigation. Its object is to maintain the status quo ante—the last actual, peaceable, and uncontested state of affairs before the controversy. Here, the status quo was the condition before the withdrawal order: Boie-Takeda’s Danzen was a registered and legally marketed drug. The injunction aimed to preserve this state while the merits of Boie-Takeda’s challenge to the administrative ban were being adjudicated by the Court of Appeals.
The Court emphasized that the sole inquiry in this certiorari proceeding was the existence of grave abuse of discretion by the appellate court in granting the ancillary relief, not the underlying issue of whether Boie-Takeda was denied due process in the administrative proceedings. The appellate court granted the writ after a hearing where both parties presented arguments, fulfilling procedural requirements. As a general rule, the Supreme Court refrains from interfering with a lower court’s exercise of discretion in issuing preliminary injunctions absent a clear showing of manifest abuse. No such abuse was found. Therefore, the petition was denied, and the injunction remained to preserve the status quo pending final resolution of the main case.