Parliament Calls For Ceasefire In Tobinco-FDA Tussle

The Chief Executive Officer of Tobinco Pharmaceutical Limited, Mr Samuel Amo Tobin, has welcomed the decision of the Parliamentary Select Committee on Health to intervene in the company’s disagreements with the Food and Drugs Authority (FDA). He described the intervention as “a good thing” and expressed the hope that it could help resolve the problem between the company and the authority. Reacting to a call by the committee for a ceasefire in an interview, Mr Tobin said a media war between one of the country’s biggest drug distributors and its regulator would not be in anybody’s interest. He, however, appealed to the committee to act quickly, so that “we can get on with what we do best — importing and distributing good quality drugs for Ghanaians”. He noted that drugs were perishable goods and had expiry dates. According to him, if the issue was not expeditiously dealt with, “it can hurt our business”. Meanwhile, the workers of the company and about 2,000 well-wishers, have since yesterday, been holding prayer sessions for a way out of the company's current problems with the FDA. According to Citi News, “The management of the company and its workers believe the current crisis the company is going through could be spiritual, hence organising prayer sessions to drive the devil out”. The Spokesperson for the workers, Daniel Kweku, revealed that “their decision to embark on the prayer is because the issue at hand is beyond what any human eye can see”. Similar prayer sessions are ongoing in the Volta and the Ashanti regions. The company has also declared today a prayer and fasting day. Parliamentary Committee The Parliamentary Committee on Health yesterday called for a halt in the ongoing media war between Tobinco Pharmaceutical, the Ministry of Health and the Pharmaceutical Society of Ghana (PSG), on the one hand, and the FDA, on the other. It said it deemed the current situation as unnecessary and unhelpful and urged all parties to cooperate in the ongoing inquiry to create a congenial atmosphere for the resolution of all issues. Moratorium In a press statement issued in Parliament yesterday, the committee recommended that the FDA should consider granting a moratorium of at least three months to all affected manufacturers and importers of food, medicines, herbal preparations and medical devices. That, according to it, would bring their products into compliance immediately as required under the Public Health Act, 2012. Tact and discreetness The committee asked the law enforcement agencies to exercise tact and discreetness in their efforts at investigating and enforcing the law in consonance with the rule of law. "We believe that only painstaking investigations will lead to successful prosecution of offenders," it said. The statement added that due attention should be paid to the reputation and integrity of business concerns until they were proved guilty of an offence. "The committee wishes to assure the public that all will be done in collaboration with major stakeholders to protect the public health of residents of Ghana," it stated. Background Tobinco applied for an interim injunction at the Accra High Court against the FDA to restrain the latter from further destroying the products of the company . Although Tobinco claims to have complied with all the laws in relation to the importation of drugs into the country, particularly the Public Health Act 2012, Act 851, there has been counter-claims by the FDA. The company averred that after registration of a particular drug with the FDA, the company started distributing that drug throughout the country and added that it was only when the drug had been certified and registered with the FDA that it went ahead to distribute it. According to it, in September 2013 the FDA, which detected that some drug had not gone through clinical trials in India, summoned Tobinco and the Indian manufacturer and the manufacturer explained that since the drug had already gone through clinical test, it was thought that there was no need for it to go through further clinical trials. Not satisfied with the explanation, the FDA imposed a GH˘40,000 fine on Tobinco for the importation of an unregistered drug, which was duly settled. Since then, the feud between the two parties has degenerated into a media war, with FDA sticking to its ground that Tobinco had violated some regulations, while Tobinco insists that it has done nothing wrong.