The Food And Drugs Authority�s (FDA�s) Puerile, Concocted And Mischievous Lies And Smear Campaign Against Him (3)

In Mr. Samuel Asante Boateng�s press release dated October 15, 2013, followed by his smear campaign against me on several FM stations, he always sought to give the impression that the FDA provides honest services that are above reproach. But from where I sit as President of the Pharmaceutical Society of Ghana (PSGH), I get a lot of information from my professional colleagues who are pharmaceutical manufacturers and importers and I can assure him that none of them respects the FDA because of the alleged corruption, lack of transparency, arbitrariness, vindictiveness, know-it-all attitude and autocratic style of the FDA leadership. Officials of the FDA have allegedly turned the place into a �gold mine� where they mine �gold� with careless abandon. Pharmaceutical importers and manufacturers who want to register or even re-register their medicines through the front door have to wait for about two (2) years or more after submission of their applications and samples in order to have the registration process completed. However, the back door is allegedly always opened for those who cannot wait for two years or more to have priority attention after allegedly putting some �weight� on their applications. And this is dangerous and unacceptable. If the leadership and staff of the FDA are true Christians then I humbly urge them to read 1 Timothy 6:10 and Jeremiah 17:11 and pray to the Almighty God to help them to repent, otherwise they are seriously heading towards a dangerous land mine. It may be recalled that as part of its long term strategy of ensuring that medicines are regulated in accordance with international best practices, the PSGH advocated for the setting up of a new medicines regulatory authority in the early 1990�s; and worked assiduously with the MOH and the then PNDC Government to pass the PNDC Law 305B that set up the Food and Drugs Board, now Food and Drugs Authority (FDA). Before the setting up of the Food and Drugs Board(now FDA) its current functions as regards medicines regulation were performed by the Office of the Chief Pharmacist and Director of Pharmaceutical Services of the MOH with support from the Quality Control Laboratory of the Pharmacy Board/ Council, from where the FDA started. At that time the �WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce� was in use; and applications for registration and re-registration of medicines could even take less than three months to be completed. So why does it now take about two years or more for an application to be completed? THIS IS A SHAME!! And I humbly call on the BNI, the EOCO, the Police and the National Security to interrogate the FDA to find out the root cause of the delay. I have credible evidence that all the medicines imported by Tobinco Pharmaceuticals from India were cleared either through the Tema harbour or Kotoka International Airport after obtaining clearance certification permits issued by officials of the FDA. Again I have credible information that the Customs Chemists do not authorize the release of any consignment of medicines from the ports without the relevant permit from the FDA. So how were the large consignment of the so called unregistered medicines imported by Tobinco cleared from the ports and got distributed across the country? This is what I urge the BNI and EOCO to investigate instead of harassing innocent pharmacists in hospitals, Regional Medical Stores and Community Pharmacies; after obvious regulatory failures by the FDA. Even today, I have credible information that the Head of Upper West Regional Medical Stores at Wa, has been invited to report to the Executive Director of EOCO in Accra to give information on some drugs supplied by Tobinco Pharmaceuticals Ltd. I know that EOCO might allegedly detain this innocent pharmacist for three days under the pretext of non- completion of investigations just to satisfy the senseless whims and caprices of the FDA leadership. I wish to pose the following questions: 1. Can�t the Upper West Regional office of EOCO carry out the investigations? 2. Are they not aware that procurement of stores for health facilities go through a certain process and if they need to be removed or destroyed, will have to go through a similar process and not just by media instructions from the CEO of FDA? 3. Why do the EOCO officials not interrogate the FDA to know how the medicines crossed the ports to reach the Upper West Regional Medical Stores? The CEO and staff of the FDA always give an impression that Tobinco products enter Ghana by road just like some smuggled counterfeit medicines. But it is just hocus-pocus to cover-up their incompetence. All Tobinco products imported from India enter Ghana through approved ports of entry. I also have evidence that Mr. Samuel Asante Boateng, a Principal Regulatory Officer of the FDA has for the past five (5) years been on the payroll of Tobinco Pharmaceuticals as a Consultant to support Tobinco in all regulatory aspects of the business. He is on a Consultancy fee of GHC2,000. 00 a month and his Consultancy appointment was allegedly endorsed by the CEO of the FDA. This is a clear case of conflict of interest by the leadership of the FDA. I wish to state emphatically that the seizure and destruction of medicines from hospitals, Regional Medical Stores and Community Pharmacies across the country by the FDA officials is unlawful and must be stopped. Under sections 82 (c) and 116 of the Public Health Act, 2012 (ACT 851), the CEO of the FDA can only make an order for the quarantine of medicines. However, it is only the Hon. Minister of Health who can by Executive Instrument prohibit the importation, manufacture, exportation, advertisement or sale of a drug outside the courts. Therefore the seizure and destruction of medicines from hospitals, Regional Medical Stores and community pharmacies by FDA officials on the orders of the CEO is unlawful. Again the blacklisting of Bliss GVS Pharma Ltd by the CEO of FDA is unlawful and ought to be reversed. Moreover, I have documents that indicate that the FDA allowed Tobinco Pharmaceuticals to clear medicines from the ports and detained in the Tobinco warehouse pending completion of their registration and subsequent final release. The CEO of the FDA, without recourse to any administrative hearing and the governing Board imposed tens of thousands of Ghana cedis on Tobinco, then allegedly out of the blue, on the orders of the CEO , FDA officials went to the Tobinco warehouse, seized all the medicines worth millions of Ghana Cedis and had them destroyed. This heartless decision of the FDA is unacceptable and must be discouraged. At this juncture I am humbly appealing to His Excellency, President John Dramani Mahama that the excessive use of the BNI, EOCO, Police CID, etc by the CEO of FDA, for solving simple issues involving players in the pharmaceutical industry and even FDA staff is unacceptable and must stop now!! It also poses a threat to the pharmaceutical industry in general of which Ghana has comparative advantage in the ECOWAS region, if it is properly nurtured and given proper regulatory guidance. In conclusion, I wish to appeal once again to the good people of Ghana, including the Government, Media and Security Agencies to take a cue from the popular Latin adage �Corruptio optima pessima� i.e. �the corruption of the best is the worst� and demand from the CEO and staff of the FDA the core values of transparency, probity and accountability. The alleged corruption, heartless decisions, lies, arbitrariness, capricious use of power, disrespect of clients and know-it-all attitude must be halted, otherwise Ghana will not be a safe place to live as far as access to quality, safe, efficacious and affordable medicines is concerned. ���� (Accra, 18th November, 2013). Pharm. James Ohemeng Kyei (0244-825454; [email protected]) (Retired Chief Pharmacist & Director of Pharmaceutical Services MoH/GHS)