republic of the philippines department of health food and ... for... · republic of the philippines...

Republic of the Philippines Department of Health

Food and Drug Administration

Guidelines for Availing of

Compassionate Special Permit

(CSP) for Restricted Use of

Unregistered Drug, Medical

Device, and Food Products

Conference Room, 2nd Flr, Main Building, FDA

5 February 2016

1

Presentation Outline I. Legal Bases II. Background: FDA and Administrative Order No.

4 s. 1992 III. Draft Guidelines for Availing CSP

A. Scope and Objective B. General Guidelines C. Eligibility for CSP D. Application Requirements E. Submission, Evaluation Process, and Decision F. Post-Approval Commitment

IV. Discussion Center for Drug Regulation and Research

2



Center for Drug Regulation and Research 3

I. LEGAL BASES Draft Administrative Order

The 1987 Constitution


The 1987 Constitution Article II, Section 15

Article XIII, Section 11


Republic Act No. 3720





II. BACKGROUND: FDA AND AO NO. 4 S. 1992

Draft Administrative Order

The Food and Drug Administration

Office under the Department of Health

Created in 1963 by virtue of Republic Act 3720 as amended by Executive Order No. 175, and subsequently Republic Act No. 9711

12

Mandate To ensure the safety, efficacy, and quality of

health products

o Food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, and household/urban hazardous substances and/or a combination of and/or a derivative thereof

13

Mandate To regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products

14

Regulatory Framework Elements

1. Licensing/Accreditation of establishments • GMP, GDP, GSP, GCP, and GLP

2. Pre-marketing assessment • Quality, safety, and efficacy (for innovative medicines)

• Quality+interchangeability (for generics)

3. Post-marketing surveillance • Safety (benefit/risk balance)

• Quality (quality testing and compliance monitoring)

4. Communication

15

Post-Marketing Surveillance

1. Pharmacovigilance

Safety monitoring of drugs on the market for unexpected health risks and informing the public of risks posed by specific drugs and other health products;

2. Monitoring, collecting, sampling and testing of drugs

3. Audits and inspection of manufacturers/ distributors/ retail outlets

4. Advertisements and claims monitoring

5. Consumer reporting of ADR

6. Product recall / Administrative sanctions

16

Use of Unregistered Products

k), Section 7, amending Section 11 of RA 3720

Prohibited acts:

However..

FDA and DOH recognizes the need for drug, medical devices, and food products which are not registered or are in the process of registration in the Philippines by patients who are terminally or seriously ill.

Access to these products for these patients is morally, socially and ethically justified when there is no existing superior alternative therapy that can likely cure or adequately control their conditions.

23 February 2016 18

Administrative Order No. 4 s. 1992

23 February 2016 19


Compassionate Special Permit for Restricted Use of Unregistered Drug and Devices Product (CSP)

a special permit signed by the FDA Director granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.

20 23 February 2016


For patients suffering from the following conditions:

1. Acquired Immune Deficiency Syndrome (AIDS)

2. Cancer

3. Life-threatening conditions

23 February 2016 21

Meetings/Consultations 13 April 2015

o Meeting with Philippine Hospital Association and Philippine Society of Hospital Pharmacists

5 May 2015 o Meeting with Marketing Authorization Holders

22 October 2015 o Consultation with Philippine Hospital Association, Philippine

Society of Hospital Pharmacists, and Marketing Authorization Holders

5 February 2016 o Consultation with Philippine Society of Hospital Pharmacists,

and government agencies, and Philippine Medical Association


Issues – Meeting 1

Regular request (from 2 to 12 times a year) for permit to import of unregistered to be used for critical care, strictly for their own use

Quantity is considered to be substantial

Misalignment with the intentions of AO 4 s. 1992 – no specific patients identified

Submission of clinical reports

23 February 2016 23

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Colistimethate Na 1 M Unit vial 7600 37170 44770 13 23 36

Dipyridamole 10mg/2ml ampoule 10333 16382 26715 12 18 30

Glyceryl trinitrate 10mg/10ml amp 14990 9319 24309 8 20 28

Protamine sulfate 50mg/5ml vial 11475 6691 18166 13 22 35

Vasopressin 20 units/ml vial 4425 6895 11320 10 14 24

Adenosine 6mg/2ml vial 3963 5605 9568 15 30 45

Phenylephrine 1% 10mg/1ml vial 2700 4985 7685 9 17 26

Papaverine HCl 30mg/ml, in 2ml vial 1495 2908 4403 8 19 27

Esmolol HCl 10mg/ml, in 10 ml vial 1405 2958 4363 10 21 31

Milrinone lactate 10mg vial 2302 2057 4359 10 14 24

Dantrolene sodium 20mg/65mL vial 408 850 1258 11 20 31

Top Requested Drugs

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Sotalol 80mg tablet 10400 13030 23430 2 2 4

Propafenone 150mg tablet 4400 14500 18900 1 2 3

Liothyronine (Cynomel) 25mcg tablet 7220 7800 15020 4 4 8

Co-trimoxazole (Trimethoprim 16 mg/ml +

Sulfamethoxazole 80 mg/ml) [Bactrim]

Solution for injection, in 5ml vial

1450 9112 10562 3 8 11

Fludrocortisone 0.1mg tablet 3100 5800 8900 2 4 6

Provocholine nebulization kit 1700 3400 5100 2 2 4

Provocholine 100mg/vial 288 475 763 2 2 4

Top Requested Drugs

Hospitals No. of applications per year

2013 2014 Total

St. Luke's Medical Center – Global City 6 12 18

St. Luke's Medical Center – Quezon City 8 8 16

Cardinal Santos Medical Center 8 7 15

The Medical City 5 7 12

Philippine General Hospital 7 3 10

Makati Medical Center 3 6 9

University of Santo Tomas Hospital 2 6 8

Asian Hospital and Medical Center 2 5 7

Manila Doctors Hospital 2 5 7

Philippine Heart Center 2 2 4

Top Requesting Hospitals

Issues – Meeting 2

MAHs do not intend to register due to low volume

MAHs are not aware of the importation of their products

MAHs receiving ADRs of products they have not imported

“Out of stocks” and “already registered”

23 February 2016 27

Issues – Others

Little/No communication between physician and therapeutics committee of hospitals

Compliance to clinical trial report submission as part of post-approval commitment - poor

23 February 2016 28




III. DRAFT GUIDELINES FOR AVAILING CSP

Draft Administrative Order

Objective Provide the rules and regulations for

securing CSP


Compassionate Special Permit

“a special permit issued by FDA granting a hospital the privilege to avail of an unregistered drug, medical device, or food product through a licensed importer for a specific kind/type of patients, specific volume and period”


Scope Licensed importer of drug, medical device,

and food products

Medical practitioners and members of hospital therapeutics committee

patients


General Guidelines A. CSP

o only for specific categories o requested by hospital through the therapeutics

committee. o specific for its identified patient/condition, volume, and

the specified hospital

B. Only licensed importers may facilitate the importation

C. A post-approval report shall be submitted by the hospital in coordination with the licensed importer

D. requirements for pharmacovigilance reporting (timelines) shall apply


Who may Apply? Specialty Institutions (SI) – specialty

hospitals

Specialty Societies (SS) through their respective institutions – primary, secondary, tertiary


Eligibility Category A: Products for Specific Patients

o Drug products for treatment of life threatening conditions

o Food for special medical purposes (with life threatening conditions)

Category B: Drugs without Prior Identified Patient o Antidotes

o emergency-use drugs

o Ready-to-use therapeutic foods (for severely and moderately acute malnourished children)

Category C: Drugs undergoing registration


Application Requirements

A. Application Form

B. Supporting Documents

C. Proof of Payment


A. Application Form (1) Product details

Product Name

Name of foreign supplier and locally-licensed importer

Total number/volume requested: o Cat A: total dosage/volume reqd for therapy

o Cat B,C: total dosage required to cover a maximum of 5% of the total bed capacity of the institution enough until the end of each year

o Computation shall be submitted

For drugs: dosage strength, form, and availability


A. Application Form

(2) SS or SI Details

Name, address, contact details of the SI, or the SS and the corresponding institution

Name and license number of the prescribing physician, and chair of therapeutics committee


A. Application Form

(3) Waiver and Acceptance of responsibility

The Application form shall act as:

the official waiver of responsibility of FDA for the use of the product, and

the acceptance of responsibility of the SS or SI


B. Supporting Documents

For Cat A: Medical Abstract of the identified patient

For Cat B and C: justification that there is no existing superior alternative therapy available


Proof of Payment

Cat A: no fees

Cat B and C: existing fees shall apply


Submission, Evaluation Process, and Decision

All submission shall be in PDF format

Category A: Email/web-based

Category B and C: existing process for permits and certificates


Submission, Evaluation Process, and Decision

Completeness and compliance to requirements

CSP validity: until the end of the year


Post-Approval Commitment

Physician and importer: to submit reports:

Clinical experience – therapeutic effect initially desired and actual results of treatment; observed AE

Reconciliation of number/volume of products requested and used, and the corresponding patients

Additional product details – name and address of manufacturer, batch/lot number


Post-Approval Commitment

Reports shall serve as prerequisites for an application for renewal of CSP

Requirements of PV reporting shall apply





IV. DISCUSSION Draft Administrative Order