PSGH Responds To FDA

PRESS RELEASE BY PHARM. JAMES OHEMENG KYEI ON MR. SAMUEL ASANTE BOATENG OF THE FOOD AND DRUGS AUTHORITY�S (FDA�S) PUERILE, CONCOCTED AND MISCHIEVOUS LIES AND SMEAR CAMPAIGN AGAINST HIM.(2)

In Mr. Samuel Asante Boateng�s press release of October, 15, 2013, he stated inter alia:

�Currently, the Medicine Registration processes put in place by the FDA is as per the format prescribed by the WHO and is in consonance with international best practice. The FDA cannot afford to use primitive methods to register medicines.

The registration process of medicines is not for toddlers in Nursery school and it is not the same as dispensing of medicines in pharmacies and chemical shops.

This process involves manufacturing site verification, dossier evaluation, quality assessment of samples the medicines and this is carried out by Experts who are well trained in this field. For example I have specialized in Pharmaceutical technology and medicines regulation at the University of Bradford, U.K. Most of my other colleagues at the FDA have also been trained in various fields of medicines regulation�.

I am not surprised that the FDA did not even acknowledge receipt of the PSGH letter dated 6th June 2013, which sought audience with the FDA to discuss regulatory challenges of the Authority and as a way forward, offer suggestions for improvement in the interest of the good people of Ghana. Mr. Samuel Asante Boateng and his likes at the FDA know all in Drug Regulation and are therefore �allergic� to suggestions from the PSGH. Mr. Samuel Asante Boateng claims he is an Expert trained at the University of Bradford UK and therefore knows it all. Yet applications for registration and re-registration of medicines may take about 2 years.

Large quantities of medicines are cleared from the ports under the supervision of FDA officials. Then after distribution throughout the country, FDA officials use state resources to go round, seize these medicines and destroy them. EXPERT IN DRUG REGULATION INDEED!!! A CRASS DISPLAY OF ARROGANCE and BOASTFULNESS!! If Mr. Samuel Asante Boateng is a true Christian he should read Proverbs 16: 18 and James

4: 6b and pray to the Almighty God to help him stop his boastfulness and arrogance and be humble. Does he think that he is the only University of Bradford School of Pharmacy Alumnus in Ghana? Surely, he is not the only one; just that people don�t advertise it on their foreheads and boast with it. For the information of Mr. Samuel Asante Boateng, I had my postgraduate training in Bradford before he went there. But for me it is one�s contribution to the Society which is more important and not mere acquisition of degrees.

About two weeks ago, Mr. Kojo Oppong Nkrumah of Joy FM called me on phone to comment on how the Pharmaceutical Society of Ghana (PSGH) could help to improve on regulatory functions of the FDA. Indeed I had a number of suggestions in mind; but as soon as I suggested that the FDA might consider re-participation in the �WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce� to hasten the registration processes, Mr Samuel Asante Boateng had the impudence to tell me that it was because I had �grown so old� that I was suggesting such a primitive procedure; and that Ghana�s FDA had gone beyond the WHO Certification Scheme. However, many National Regulatory Authorities in the First World, including even the FOOD AND DRUG ADMINISTRATION (FDA) OF THE UNITED STATES OF AMERICA, Room 15 5600 Fishers Lane,

Rockville,MD20857 still participate in the Scheme because it gives value for money. Yet Mr. Samuel Asante Boateng continues to label the Scheme as very primitive on a number of FM Stations in Accra. It may be recalled that before the passage of the PNDC Law 305B, that set up the Food and Drugs Board now FDA, the current functions of the FDA were performed by the Office of the Chief Pharmacist and Director of Pharmaceutical Services of the MoH with support from the Pharmacy Board/Council Quality Control Laboratory, from where the FDA started.

At that time the WHO Certification Scheme was in use, and applications for registration or re-registration of medicines could even take less than one month to be processed. The expectation therefore was that under the FDA, the registration and re-registration processes might even be shortened. But alas! It is now takes about 2 years to be processed. WHAT A SHAME!!

The WHO Certification Scheme was developed by the World Health Organization (WHO) in response to the request of WHO Member States to facilitate international trade in pharmaceutical products between member states. The Scheme is an administrative instrument that requires a participating Member State (a certifying country), upon application by a commercially interested party (the applicant company), to certify/attest to the competent authority of another participating Member State (the recipient country) that:

� A specific pharmaceutical product is authorized for marketing in the certifying country, or if not, the reason why authorization has not been accorded.

� The manufacturing facilities and operations conform to good manufacturing practices (GMP) as recommended by WHO.

The Scheme operates as follows:

1. The certificate recipient authority has in its national medicines legislation or guidelines a requirement for the submission a Certificate for a Pharmaceutical Product (CPP) for products being imported into the country as a support to ensure the quality of the product being imported. (In some countries the CPP forms part of the dossiers to be submitted to the national medicine regulatory authority (NMRA) to have a product registered by the authority).

2. The applicant/importing company requests a CPP from the certifying authority through the exporting company.

3. The certifying authority issues a CPP to the importing/applicant company via the exporting company. (At the time of the development of the scheme, the understanding was that a CPP would be sent directly to the recipient authority by the issuing authority.

(Ref : WHO Working document QAS/10.374 pp2&3)
It is interesting to note that, if the FDA of the United States of America with all its huge human and material resources even participates in the WHO Certification Scheme because it gives value for money then why should Mr. Samuel Asante Boateng say on Joy FM and other FM stations that I have �grown so old� as to suggest the use of such a primitive regulatory procedure? Is it because of his know-it-all posture, arrogance and lies? Is it because he and his likes at the FDA regard the PSGH as an enemy? Mr. Samuel Asante Boateng should take a cue from the Latin Adage �Fas est et ab hoste doceri� i.e. �It is right to learn even from an enemy�.

Mr. Samuel Asante Boateng and his likes at the FDA should also take a cue from another Latin Adage �Ab ove maiori discit arare minor�i.e �From the older ox the younger learns to plough�. The fact that I retired at age 60 does not mean that I am useless. If nothing at all, I have a wealth of experience from which the younger could tap.
In the recent impasse over GSUNATE Plus suppositories, if the FDA in Ghana had participated in the WHO Certification Scheme, there would have been a cordial relationship between the FDA and the pharmaceutical importer; because as part of the regulations, the Indian Regulatory Authority, the Central Drugs Standard Control Organization (CDSCO) would have provided all the documented information requested by the FDA i.e.

1. Registration of the product as an anti-malarial in India.
2. Whether clinical trials had been done on the medicine and results of the trial.
3. Whether the manufacturing facilities and operations conform to good manufacturing practices (GMP) as recommended by WHO.

Without this documented information from CDSCO in India, the product should not even be allowed entry at our ports. Therefore the WHO Certification Scheme is still relevant and provides value for money in spite of Mr. Samuel Asante Boateng�s assertion that it is primitive.

Mr. Samuel Asante Boateng keeps on boasting at some FM stations in Accra that Ghana FDA has been commended by the WHO and Uganda. But I believe that it is his usual lies galore or that the FDA did show only one side of the coin to the visitors. If both sides of the coin had been shown I believe that no matter the indicators used by the visitors, FDA would not have been commended highly as Mr. Samuel Asante Boateng would want the good people of Ghana to believe. Who will praise a Medicines Regulatory Agency that takes about 2 years to process one application for medicines registration? An Agency that allegedly uses intimidation to regulate pharmaceutical products. And an Agency that faces so many allegations of corruption and lack of transparency. Mr. Samuel Asante Boateng may wish to show evidence of the commendations.

Mr. Samuel Asante Boateng�s comment that the registration process of medicines is not for toddlers in Nursery school and it is not the same as dispensing of medicines in Pharmacies and chemical shops is most unfortunate. What it really means is that if he has done dispensing before, then he did so without reference to Good Dispensing Practices as spelt out in the Standards of Pharmaceutical Care document. Otherwise he would not have made such comments.

At this juncture I am making a passionate appeal to the good people of Ghana to demand from Mr. Samuel Asante Boateng and his likes at the FDA the core values of transparency, probity and accountability; otherwise Ghana is not safe as far as access to quality, safe and efficacious medicines is concerned.

Finally, I wish to reiterate the call by the PSGH to Mr. Samuel Asante Boateng and his likes at the FDA that if they do not have anything to hide, if they are men of conviction and courage then they should appear before the Committee set up by the MoH to investigate the numerous allegations of corruption, intimidation and incompetence made against them.

I am also ready to appear before the committee to prove my innocence with respect to allegations of the importation of fake psychotherapeutic medicines and condoms made against me by Mr. Samuel Asante Boateng, the GARGANTUAN LIAR.

I wish however to add that it is sheer wickedness and even criminal for Mr. Samuel Asante Boateng to link me with the so called fake condoms procured about three (3) years after I had left office. But as the Latin Adage goes �Facta sunt potentiora verbis� i.e. Facts are more powerful than words. By the Grace of the Almighty God we all live to see.

Signed
Pharm James Ohemeng Kyei