PSG Prez Dares FDA�Describes Accusation Against Him As �Puerile�, �Concocted� And A �Smear Campaign�

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. My attention has been drawn to a press release by Mr. Samuel Asante Boateng of the FDA pasted on various news websites and published in full in the Ghanaian Times of Friday 18th October, 2013. The said Mr. Samuel Asante Boateng also went to various FM stations peddling lies and falsehood meant to tarnish my hard won reputation and image; and that of the Pharmaceutical Society of Ghana (PSGH) to which he belongs. The aforementioned press release which was under the caption �Ministry of Health Press Release: Self Indicting and Embarrassing� made unfounded and malicious allegations against the PSGH and his President on some issues. But the Executive Secretary has already responded to the allegation against the PSGH. I will therefore focus on the allegation against me which read as follows: �The Ministry should recall that it is this same post market surveillance system of the FDA that uncovered the importation of substandard psychiatric medicines by the Ministry of Health in 2010 and the FDA ordered the immediate re-exportation of these substandard psychiatry medicines. During that time the current President of the Pharmaceutical Society of Ghana (PSGH), Mr. Oheming Kyei (name even wrongly spelt) was the Chief Pharmacist of the MOH�. �The FDA confiscated and quarantined in the Central Medical Stores of the MOH 130 million pieces of substandard condoms (Be safe Condoms) imported by the Ghana Health Service, worth 6 million US Dollars of Global Fund money. Who are the people in charge of procurement at the Ghana Health Service and the MOH?� When in office at the MoH as the Chief Pharmacist and Director of Pharmaceutical Services, I served my country faithfully and diligently. I was not a �one man procurement committee�. I therefore unequivocally deny any connection with the procurement of so called substandard psychotherapeutic medicines when in office. It is also sheer wickedness to willfully link me with the procurement of so called fake condoms in 2013, about three (3) years after leaving office. Even though Mr. Samuel Asante Boateng is known to have the habit of telling lies and as the Latin adage goes �Consuetudinis magna vis est� i.e. �old habits die hard�, I never thought that he could tell such GARGANTUAN LIES just to smear his President. INCREDIBLE INDEED!!! I have documents to prove that in 2010, the MoH never ever imported any substandard Psychotherapeutic (psychiatry) medicines; which the FDA ordered their immediate re-exportation. This allegation is like a fairy-tale in a story book. If Mr. Samuel Asante Boateng is a true Christian he should read Exodus 20: 16 and Proverbs 14:5 and bow his head in shame!! The procurement system of the MoH is in accordance with the Procurement Law of Ghana, (ACT 663). The MoH procures psychotherapeutic medicines from importers through International Competitive Bidding (ICB). In 2010, twelve registered pharmaceutical companies were awarded contracts by the MoH to supply forty two (42) different psychotherapeutic medicines after going through tender evaluation scrutiny by a team whose membership included an official of the FDA, Madam Evado Avotri. The companies which won the contracts were as follows: SUPPLY OF PSYCHOTHERAPEUTIC MEDICINES TO THE MoH IN 2010 COMPANY TYPES OF MEDICINES AMOUNT(USD) Janssen C/ Abba Scientific 3 104,646.67 Ernest Chemists Ltd 8 72, 641.00 Sun Pharma Ind. Ltd 2 22,095.00 Cipla Limited 1 14, 040.00 Aurobindo Pharma Ltd. 2 28,020.00 Kinapharma Ltd 5 15,000.00 Surgi and Medic Int. Ltd 5 151,432.50 Rock Chemist 5 33,488.00 Intas Pharma Ltd. 1 67,672.00 Laboratoires Lafran 5 28, 157.50 Amex Pharmacy Ltd 1 386.00 Gokals Ltd 4 39, 567.00 12 COMPANIES 42 ITEMS 577,146.27 My request to Mr Samuel Asante Boateng therefore is to indicate which of the above companies supplied the re-exported substandard psychotherapeutic medicines. Data available to me, indicates that all the 42 types of psychotherapeutic medicines supplied by the 12 Pharmaceutical companies were consigned to the Central Medical Stores, Tema and quarantined whilst samples were taken to the FDB for quality evaluation. None of these medicines was re-exported on arrival at the ports to anywhere as claimed by Mr. Samuel Asante Boateng. According to analytical reports on the psychotherapeutic medicines dated 6th April, 2010, signed by Dr. Stephen Kwabena Opuni, CEO of the FDA; and addressed to the Head of the Central Medical Stores, one of the medicines namely chlorpromazine injection (50mg/2ml) did not comply with pharmacopoeia requirement for assay. Indeed it contained more of the active pharmaceutical ingredients than the pharmacopoeia standard. IT DOES NOT MEAN THAT IT WAS FAKE!! Subsequently, the whole consignment of that particular injection was destroyed on the orders of the FDA at the Kpone landfill site in the presence of an official of the FDA , Denyce Dorbu, who issued a certificate of destruction to the Head of the Central Medical Stores. The Procurement Unit of the Directorate of Procurement and Supply then wrote to the supplier to replace the item. According to information available to me, apart from the aforementioned chlorpromazine injection, all the other 41 consignments of psychotherapeutic medicines were supplied to the psychiatric hospitals for use by our valued patients. I therefore challenge Mr. Samuel Asante Boateng to produce documentation as proof of the so called psychotherapeutic medicines that were re-exported on the orders of the FDA. These include but not limited to the following: Companies whose products were re-exported; Date of re-exportation; List and quantities of medicines re-exported; Batch numbers; Dates of Manufacture and Expiry; and Officials of the MoH headquarters, Procurement Unit and Central Medical Stores who witnessed the so called re-exportation. I wish to assure Mr. Samuel Asante Boateng and those who may be �pushing� him but hiding behind the smokescreen of anonymity that the smear campaign against me will not yield any useful dividends. My peers bear testimony that throughout my 35 years working career in the MoH and its Agencies, I was always guided by the core values of transparency, probity and accountability. Again my peers bear witness that I started fighting the fake drug menace as far back as in the early 1980�s. I led a crusade to bust one criminal gang who stole empty red and black gelatin shells from an Accra pharmaceutical company, filled them with powdered cassava in a house at Labadi Aborme; and then packed and sold them as ampicillin capsules. Following investigations by the Investigations and Complaints Dept. of the then Ashanti Regional Secretariat of the National Defence Committee (later Ashanti Regional Defence Committee), where I lodged the complaint, they were tried and convicted by the National Public Tribunal. I again led a crusade that led to the arrest of another criminal gang in Kumasi who filled empty alpha-chymotrypsin containers with summavit forte tablets (a vitamin preparation) and then had them sold as alpha-chymotrypsin tablets. These criminals were convicted by the then Ashanti Regional Public Tribunal. Therefore I support any war on fake medicines. However, my worry is that there is no transparency at the FDA. There are serious allegations of corruption which ought to be investigated and halted. Applications for registration and re-registration of pharmaceutical products may take about two years. Fees charged by the FDA for registration of new chemical entities and other regulatory services are the highest in Africa. There are allegations that some officials of the FDA intentionally create situations to enable the Authority impose unjustifiable fines eg.GHS 40,000.00 on pharmaceutical importers; and this is passed on to the patients. So in the long run it is the ordinary Ghanaian who suffers. And they use BLATANT LIES to cover their misdeeds. I demand from Mr. Samuel Asante Boateng and his likes at the FDA, the core values of transparency, probity and accountability. Indeed, if Mr. Samuel Asante Boateng and his likes at the FDA have nothing to hide; if they are men of conviction and courage, then they should appear before the committee set up by the MOH to investigate their operations. I have other comments to make on issues raised by Mr. Asante Boateng at some FM stations in my next press release. Pharm. James Ohemeng Kyei ( Former Chief Pharmacist and Director of Pharmaceutical Services, MoH/GHS ) [email protected]; Cc: Chairman, National Media Commission, Accra. Hon. Minister for Health, Ministry of Health, Accra.