This case has been cited 1 times or more.
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2015-07-28 |
PERALTA, J. |
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| Similarly, in Republic v. Drugmaker’s Laboratories, Inc.,[28] the validity of circulars issued by the Food and Drug Administration (FDA) was upheld in spite of the non-compliance with the publication, prior hearing, and consultation requirements for they merely implemented the provisions of Administrative Order No. 67, entitled “Revised Rules and Regulations on Registration of Pharmaceutical Products” issued by the DOH, in the following wise: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.42 | |||||