Case Digest (G.R. No. 190837)
Facts:
Republic of the Philippines, represented by the Bureau of Food and Drugs (now Food and Drug Administration) v. Drugmakers Laboratories, Inc. and Terramedic, Inc., G.R. No. 190837, March 05, 2014, Supreme Court Second Division, Perlas-Bernabe, J., writing for the Court.The Bureau of Food and Drugs (BFAD), later renamed the Food and Drug Administration (FDA) under RA 9711, is the agency charged by law to administer and supervise the implementation of the Food, Drug, and Cosmetic Act (RA 3720, as amended). In 1989 the Secretary of Health issued Administrative Order No. 67, s. 1989 (AO 67) setting out rules on registration of pharmaceutical products, including a requirement that certain products submit satisfactory bioavailability/bioequivalence (BA/BE) tests as part of applications for a Certificate of Product Registration (CPR). AO 67’s BA/BE requirement was not enforced initially because the country lacked local BA/BE testing facilities.
After local testing capacity developed, the BFAD issued Circular No. 1, s. 1997, reinstating enforcement of the BA/BE requirement for products listed in AO 67’s List B (Prime), and Circular No. 8, s. 1997, providing implementation details. Both circulars required pending and new registrations of listed products to submit satisfactory BA/BE results from recognized testing units.
Respondents Drugmakers Laboratories, Inc. and Terramedic, Inc. manufacture Refam (rifampicin) and were issued a CPR on November 15, 1996, renewed repeatedly until November 15, 2006 subject to submission of satisfactory BA/BE results. They engaged the University of the Philippines to perform BA/BE testing and, after the FDA informed them by letter dated July 31, 2006 that Refam was not bioequivalent with the reference drug, the FDA nonetheless revalidated the CPR twice more until November 15, 2008, the last renewal containing a warning that no further revalidations would be granted absent satisfactory BA/BE results.
Instead of submitting further satisfactory BA/BE evidence, respondents filed a petition in the Regional Trial Court (RTC) of Muntinlupa City, Branch 256, seeking prohibition and annulment of Circular Nos. 1 and 8, s. 1997, arguing that only the Secretary of Health (not the FDA) had the rule-making power under RA 3720, and that the circulars were void for lack of prior hearing, consultation, and publication. In an Order dated December 18, 2009 and a Writ of Permanent Injunction dated January 19, 2010, the RTC declared Circulars Nos. 1 and 8 null and void, enjoined the FDA from implementing them, and directed the FDA to approve renewal/revalidation of respondents’ CPRs without requiring BA/BE results.
The FDA filed a petition for re...(Subscriber-Only)
Issues:
- Under RA 3720, did the FDA have authority to issue and implement BFAD Circular Nos. 1 and 8, s. 1997?
- Do Circular Nos. 1 and 8, s. 1997, partake of administrative regulations subject to the prior notice, hearing, and publication requirements of Executive Order No. 292 (Administrative Code of 1987), such that their lack of s...(Subscriber-Only)
Ruling:
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Ratio:
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Doctrine:
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