Republic of the Philippines Department of Health Food and Drug Administration Importation of Unregistered Drug Products Center for Drug Regulation and Research Food and Drug Administration
Presentation Outline I. Food and Drug Administration II. Use of Unregistered Products III.Issues for Discussion 5 May 2015 2
Republic of the Philippines Department of Health Food and Drug Administration Food and Drug Administration
FDA • Office under the Department of Health • Created in 1963 by virtue of Republic Act 3720 as amended by Exective Order No. 175, and subsequently Republic Act No. 9711 4
Legal Bases • Republic Act No. 3720 (as amended) – Foods, Drugs and Devices, and Cosmetics Act • Republic Act No. 9711 – Food and Drug Administration (FDA) Act of 2009 5
Legal Bases • Republic Act No. 9502 – Universally Accessible Cheaper Quality Medicines Act of 2008 • Republic Act No. 7394 – Consumer Act of the Philippines 6
Legal Bases • Republic Act No. 6675 – The Generics Act of 1988 • Republic Act No. 10354 – The Responsible Parenthood and Reproductive Health Act of 2013 7
To ensure the safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practice MISSION 8
To be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos VISION 9
QUALITY POLICY Our highest commitment is to ensure the safety, efficacy and quality of health products. Toward this end, we commit to establish science- based standards as basis for regulatory policies, to continually improve and maintain our competencies in relation to our regulatory function, and to deliver quality public service with integrity. 10
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 11
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 Post-Marketing Surveillance 12
Republic of the Philippines Department of Health Food and Drug Administration Use of Unregistered Products
k), Section 7, amending Section 11 of RA 3720 • Prohibited acts: Executive Order No. 175
• FDA recognizes the need for drugs and devices product/preparation 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. 5 May 2015 15
Administrative Order No. 4 s. 1992 5 May 2015 16
AO No. 4 s. 1992 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. 5 May 2015 17
AO No. 4 s. 1992 • For patients suffering from the following conditions: 1. A cquired Immune Deficiency Syndrome (AIDS) 2. Cancer 3. Life-threatening conditions 5 May 2015 18
Application shall include: • estimated volume needed • the licensed drug/ device establishment through which the unregistered drug may be procured • identify the names and address of the specialists qualified and authorized to use the product AO No . 4 s. 1992 5 May 2015 19
Top Requested Drugs Quantity requested per year Frequency of request Drug 2013 2014 Total 2013 2014 Total 7600 37170 44770 13 23 36 Colistimethate Na 1 M Unit vial 10333 16382 26715 12 18 30 Dipyridamole 10mg/2ml ampoule 14990 9319 24309 8 20 28 Glyceryl trinitrate 10mg/10ml amp 11475 6691 18166 13 22 35 Protamine sulfate 50mg/5ml vial 4425 6895 11320 10 14 24 Vasopressin 20 units/ml vial 3963 5605 9568 15 30 45 Adenosine 6mg/2ml vial 2700 4985 7685 9 17 26 Phenylephrine 1% 10mg/1ml vial 1495 2908 4403 8 19 27 Papaverine HCl 30mg/ml, in 2ml vial 1405 2958 4363 10 21 31 Esmolol HCl 10mg/ml, in 10 ml vial 2302 2057 4359 10 14 24 Milrinone lactate 10mg vial 408 850 1258 11 20 31 Dantrolene sodium 20mg/65mL vial
Top Requested Drugs Quantity requested per year Frequency of request Drug 2013 2014 Total 2013 2014 Total 10400 13030 23430 2 2 4 Sotalol 80mg tablet 4400 14500 18900 1 2 3 Propafenone 150mg tablet 7220 7800 15020 4 4 8 Liothyronine (Cynomel) 25mcg tablet Co-trimoxazole (Trimethoprim 16 mg/ml 1450 9112 10562 3 8 11 + Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for injection, in 5ml vial 3100 5800 8900 2 4 6 Fludrocortisone 0.1mg tablet 1700 3400 5100 2 2 4 Provocholine nebulization kit 288 475 763 2 2 4 Provocholine 100mg/vial
Top Requesting Hospitals No. of applications per year Hospitals 2014 Total 2013 6 12 18 St. Luke's Medical Center – Global City 8 8 16 St. Luke's Medical Center – Quezon City 8 7 15 Cardinal Santos Medical Center 5 7 12 The Medical City 7 3 10 Philippine General Hospital 3 6 9 Makati Medical Center 2 6 8 University of Santo Tomas Hospital 2 5 7 Asian Hospital and Medical Center 2 5 7 Manila Doctors Hospital 2 2 4 Philippine Heart Center
Conclusions • 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 5 May 2015 23
Republic of the Philippines Department of Health Food and Drug Administration Issues for Discussion
Issues for Discussion • Pending Applications • Compliance to Clinical Reports • Registered counterpart
Pending applications • 19 applications on hold submitted from 24 February to 31 March 2015
Pending applications CONTROL NUMBER DATE NAME OF COMPANY PRODUCT RECEIVED 1 2015022416455 24-Feb-15 Adventist Medical Thiopental sodium 500mg 1 Center - Bacolod powder for Injection 2 2015022416473 24-Feb-15 Makati Medical Methoxsalen (GEROXALEN 8 Center 10mg capsule; Fludarabine (FLUDARA) 50mg vial 3 2015022416412 24-Feb-15 De La Salle Protamine sulfate 50mg/ ml w/ 7 University Medical 4 drug products Center 4 2015022416455 24-Feb-15 Adventist Medical Phenylephrine 1% 10mg/ 1ml 1 Center - Bacolod ampoule; Colistimethate sodium (COLOMYCIN) 1Million Unit Vial
Pending applications CONTROL NUMBER DATE NAME OF COMPANY PRODUCT RECEIVED 5 201502241643 24-Feb-15 Mary Mediatrix Dipyridamole (PERSANTIN) 37 Medical Center 10mg/ 2ml ampoule 6 201502261308 26-Feb-15 Perpetual Succour Dipyridamole (PERSANTIN) 42 Hospital 10mg/2ml ampoule 7 201502261305 26-Feb-15 University of Santo Sulfamethoxazole (SMZ) 400mg + Trimethoprim (TMZ) 80mg 20 Tomas Hospital (BACTRIM) 5ml ampule 8 201503031238 03-Mar-15 Davao Doctors Fludrocortisone acetate 57 Hospital 100mcg tablet 9 201503041220 04-Mar-15 St. Luke’s Medical Dantrolene sodium 20mg/ 28 Center 70ml vial w/ 25 drug products 10 201503050923 05-Mar-15 Chinese general Glyceryltrinitrate (NITRONAL) 09 Hospital and 1mg/ ml, 10ml ampoule; Medical Center Colistimethate sodium (COLOMYCIN) 1 million Unit Vial
Pending applications CONTROL NUMBER DATE NAME OF COMPANY PRODUCT RECEIVED 11 20150312102502 12-Mar- Cardinal Santos Labetalol 100mg/ 20ml vial 15 12 20150316133902 16-Mar- The Medical City Nicotine TDS Patch 21mg 14ct; 15 Nicotine TDS Patch 14mg 14ct; Nicotine TDS Patch 7mg 14ct; Nicorette Freshfruit 4mg; Nicorette Freshfruit 2mg 13 20150317103602 17-Mar- Asian Hospital Gebauer’s Pain Ease 15 and Medical Center 14 20150324130448 24-Mar- AUF Medical Milrinone Lactate Injection 15 Center 10mg/ vial w/ 4 drug products 15 20150324101744 24-Mar- St. Luke’s Medical Methylene blue (PATENT BLUE 15 Center V) 2mg/ ml
Pending applications CONTROL NUMBER DATE NAME OF COMPANY PRODUCT RECEIVED 16 201503241013 24-Mar-15 St. Luke’s Medical Cyclosporine SANDIMMUNE 08 Center 50mg vial 17 201503241310 24-Mar-15 Jecson Medical Dipyridamole (PERSATIN) 03 Center 10mg/ 2ml Solution for infusion/ Intravenous/ Ampule 18 201503241313 24-Mar-15 Cebu Doctor’s Persantin 10mg/ 2ml ampule 23 Univerrsity Hospital 19 201503311636 31-Mar-15 St. Luke’s Medical Vasopressin (PITRESSIN) 20 245 Center units/ ml w/ 22 drug products
Compliance to Clinical Reports • Low compliance to reporting • PMS is compromised
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