Case Digest (G.R. No. L-26762)
Facts:
In Republic of the Philippines, represented by the Bureau of Food and Drugs (now Food and Drug Administration) v. Drugmakeras Laboratories, Inc. and Terramedic, Inc. (G.R. No. 190837, March 5, 2014), the petition arises from RTC Muntinlupa City’s Order of December 18, 2009 in Civil Case No. 08-124, which invalidated BFAD Circular Nos. 1 and 8, series of 1997, enjoined the FDA from implementing them, and directed issuance of Certificates of Product Registration (CPR) in favor of respondents. Under Republic Act No. 3720 (the Food, Drug, and Cosmetic Act), as amended by Executive Order No. 175 (1987), and AO 67, s. 1989, drug manufacturers must secure a CPR after submitting satisfactory bioavailability/bioequivalence (BA/BE) test results. Respondents had a valid five-year CPR for their generic rifampicin suspension (“Refam”) issued in 1996 and renewed until November 15, 2006, on condition of submitting satisfactory BA/BE results. After obtaining an unsatisfactory BA/BE report in Ju...Case Digest (G.R. No. L-26762)
Facts:
- Regulatory Framework and Issuances
- Republic Act No. 3720 (RA 3720) created the Food and Drug Administration (FDA, formerly BFAD) to administer and enforce food, drug, and cosmetic safety standards.
- Department of Health Administrative Order No. 67, s. 1989 (AO 67) mandated bioavailability/bioequivalence (BA/BE) testing for certain pharmaceutical products prior to Certificate of Product Registration (CPR), but implementation was deferred due to lack of local testing facilities.
- BFAD Circular No. 1, s. 1997 reinstated BA/BE testing upon establishment of local facilities; Circular No. 8, s. 1997 provided supplementary implementation details.
- Respondents’ Registration and Testing History
- Drugmakeras Laboratories, Inc. and Terramedic, Inc. (“respondents”) manufactured “Refam” (rifampicin 200 mg/5 mL suspension) for tuberculosis; obtained an initial CPR on November 15, 1996, valid until 2001.
- From 2001 to 2006, respondents renewed the CPR yearly, conditioned on submission of satisfactory BA/BE results.
- University of the Philippines–Manila conducted BA/BE testing in 2006; Refam failed to demonstrate bioequivalence. Despite this, the FDA revalidated the CPR twice (until November 15, 2008) with warnings against further renewals without satisfactory BA/BE data.
- Lower Court Proceedings
- Respondents filed a petition for prohibition and annulment in the RTC of Muntinlupa City (Branch 256), contending AO 67’s BA/BE requirement derived solely from the DOH, not BFAD/FDA, and that Circulars 1 and 8, s. 1997 were void for lack of delegated authority and procedural defects.
- On December 18, 2009, the RTC declared Circulars 1 and 8, s. 1997 null and void, enjoined the FDA from enforcing them, and ordered issuance of CPR renewals sans BA/BE submissions; a writ of permanent injunction followed on January 19, 2010.
- The FDA sought certiorari relief before the Supreme Court, secured a Temporary Restraining Order on February 24, 2010, and elevated the case on a pure question of law.
Issues:
- Authority Issue
- Whether the FDA validly issued and implemented Circular Nos. 1 and 8, s. 1997 under RA 3720, as amended.
- Procedural Issue
- Whether those circulars qualify as administrative regulations requiring compliance with prior notice, hearing, and publication under the Administrative Code.
Ruling:
- (Subscriber-Only)
Ratio:
- (Subscriber-Only)
Doctrine:
- (Subscriber-Only)