AO66s1989

Republic of the Philippines Department of Health OFFICE OF THE SECRETARY Manila

March 15, 1989

ADMINISTRATIVE ORDER No. 66 s. 1989 SUBJECT: RULES AND REGULATIONS ON THE PROCESS OF REVIEW AND EVALUATION OF QUESTIONED DRUG OR DRUG PRODUCTS SUMMARY:

This Order prescribes the procedure of review and evaluation of questioned drug or drug products with the end in view of banning the same from the market or restricting the conditions of their (BFAD) registration. The same procedure or process of review and evaluation may also result to a confirmation of the efficacy, safety or therapeutic value found by BFAD during the initial registration of the drug product.

Pursuant to Section 3(c) and 26(a) of Republic Act 3720, as amended, the following rules and regulations are hereby promulgated to govern the banning from the market of drugs or drug combinations which have been found unsafe, inefficacious or of doubtful therapeutic value. SECTION 1

DEFINITION OF TERMS

1.1

“Banning” is an act to prohibit the importation, manufacture, distribution and sale of a drug determined to be unsafe, inefficacious or of doubtful therapeutic value as a consequence of which products containing such drug or drug combination shall not be registered, or if already registered, they shall be removed from the registry.

1.2

“Drug” means the active ingredient responsible for the pharmacologic or therapeutic effect of the product.

1.3

“Pharmaceutical or Drug product” is the finished dosage form that contains the active ingredient(s), generally but not necessarily in association with inactive ingredients.

SECTION 2 2.1

PROCEDURE FOR REVIEW AND EVALUATION The process of review and evaluation is initiated when reliable scientific information indicates that a drug or combination of drugs is unsafe or inefficacious or of doubtful therapeutic value; or when there is a complaint by any party with substantial interest. The complaint should be properly documented and should include the following information: 2.1.1 2.1.2

2.2

proper identification of the drug or combination of drugs description of reason to doubt its safety, efficacy, or therapeutic value.

The BFAD review process will involve the following steps: 2.2.1 Notification of affected drug establishment(s) under whose name the drug product(s) containing the questioned drug or combination of drugs was registered. The notification shall also include

information on the process to be followed in reviewing and evaluating the drug(s) in question. 2.2.2 Notification of other interested parties, if any, that BFAD is reviewing the status of the drug. 2.2.3 Submission by all interested parties of materials for against the subject drug. 2.2.3.1

Position papers shall be submitted, in 5 copies, within 30 days after receipt of notice from BFAD. 2.2.3.2 Automatic extension shall not be granted unless partial submission has been made. The extension shall be granted only when extension is expected to yield new material information and only when public safety will not compromised. 2.2.4

2.2.5

All interested parties shall be furnished copies of the materials submitted to BFAD in evidence and shall have fifteen (15) calendar days after their receipt to examine and comment on these materials. BFAD reviews all submissions and determines whether a prime facie case exists against the drug or combination of drugs. 2.2.5.1 If the case is obviously not meritorious BFAD recommends dismissal of the case to the Secretary of Health. Should the Secretary of Health that there is reasonable ground to reverse the BFAD recommendation, he shall order a public hearing.

2.2.6

2.2.5.2

If the evidence is enough to support a finding that the drug is unsafe, inefficacious, or of doubtful therapeutic value, BFAD makes the necessary recommendation to the Secretary of Health within 30 days from end of submissions.

2.2.5.3

If the evidence seems meritorious but does not support a finding, BFAD undertakes a hearing.

Process of Hearing 2.2.6.1

BFAD will publish the order and date of public hearing which shall not be later than fifteen calendar days from the date of the publication of such order.

2.2.6.2

The affected drug establishment must justify continued BFAD registration of the product on the basis of safety, efficacy, and therapeutic value of active ingredients it contains. All interested parties may present additional documentary evidence to clarify and supplement their position papers within thirty (30) calendar days from the date of initial hearing. The verified and authentic evidence and the position papers shall constitute the direct evidence on the questioned drug.

2.2.6.3

All parties are entitled to cross-examine the witnesses that may be presented by the interested parties and affected drug establishments or witnesses who may be called by BFAD to establish the authenticity, degree of accuracy and/or propriety of the reports or documents

submitted in evidence or to testify to any material fact. For this purpose, BFAD shall require all parties concerned to submit a list of these witnesses and the time frame within which they will testify. The list and the time frame shall be strictly followed. Any witness not in the list shall not be allowed to testify. Failure to testify within the approved time frame shall be deemed a waiver on the part of the interested party. 2.2.7

The BFAD may call upon a panel of experts, if nec0essary to provide additional information and to evaluate submissions and evidence. These experts shall advise BFAD on the matter.

2.2.8

The submissions and the evidence presented in the public hearing shall be evaluated by BFAD on the basis of current standards for safety, efficacy and therapeutic value as defined in A.O. No. 67 s. 1989

ANNOTATION:

Administration Order No. 67 s. 1989, the subject of which being the “Revised Rules and Regulation on Registration of Pharmaceutical Products.” It should be Noted, however, that the rules refer to “current” standards of safety , efficacy and Therapeutic value used by BFAD such that whatever may be the revised standards at the time when the questioned drug is under review will be the basis of the review and evaluation

2.2.9

The BFAD shall make a recommendation to the Secretary of Health within thirty (30) days from termination of hearing.

2.2.10 The Secretary of Health shall decide the final action to be taken and shall duly inform the parties concerned of the decision taken. 2.3

Section 3

This procedure of review and evaluation does not preclude however the BFAD from submitting a recommendation to immediately ban a drug and all products containing it in cases where there is a clear finding if serious or lethal toxicity constituting undue risk to public safety. In which cases, the BFAD shall submit its finding and recommendation, together with records of substantial evidence to the Secretary of Health for immediate action. SEPARABILITY CLAUSE

In case any provision of these rules and regulations is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect. Section 4

REPEALING CLAUSE

All other administrative orders, rules, regulations and other administrative issuance or parts thereof, inconsistent with the provisions of this Administrative Order, are hereby repealed or modified accordingly.

SECTION 5

EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in two newspapers of general circulation. ANNOTATION:

Section 11 (i) of R.A. No. 3720 as amended prohibits the manufacture, importation, exportation , sale, offering of sale, distribution or transfer of any drug or device which is not registered with the Bureau…”Therefore, generally speaking, there are only two (2) situations when the safety, efficacy and therapeutic value of drug product may be evaluated by BFAD,I.e. (1) when the drug product is sought to be registered or its registration is sought to be renewed, in which case A.O. 67 s. 1989 will be applied; and (2) when the drug or drug product is already registered and its safety, efficacy or therapeutic value is questioned; In this latter case, the procedures prescribed by this A.O. 66 s.1989 will govern the review and evaluation of the questioned drug. There is, however, another set of rules governing fixed dose combination drugs, the A.O. 96 s. 1990, that can be considered as either an exception to the general rule or a complimentary rule intended for the fixed dose combination drugs.

(Sgd) ALFREDO R.A. BENGZON Secretary