FDA gives evidence in Parliament

Accra, Jul 16, GNA - The Chief Executive of the Food and Drugs Authority (FDA), Mr Huudu Mogtari on Thursday disclosed that the Authority was not officially informed of the discontinuation of the Ebola vaccines trail by the Ministry of Health.

He told the Privileges Committee of Parliament that officials of the FDA discovered through media reports that the MOH, contrary to laid down procedures, had suspended the vaccine trial.

The revelation by Mr Mogtari's stunned members of the Committee who had been under the impression that the Minister of Health, Mr Alex Segbefia before and after announcing the suspension of the controversial vaccines trial in Parliament, had notified the FDA which has the authority to supervise such clinical trials.

"We read from the newspapers that the Ministry had ordered the suspension of the trial but there was no official communication from the Ministry of Health regarding the suspension," he said.

The Chief Executive who was testifying at the Committee's last sitting on the contempt charges brought against Professor Alex Dodoo, a Pharmacologist and a lecturer at the School of Medicine and Dentistry of the University of Ghana, said in January, this year, the FDA received two applications from two organisations to conduct clinical trials of Ebola vaccines in the country.

He said the FDA gave a conditional approval for the trials to begin after applying its standard operating guidelines and procedures regarding such matters.

Mr Mogtari explained that with the conditional approval, the companies involved in the trial could go ahead to recruit people they intend to use for the trial.

He told the Committee that just as the FDA was preparing to announce the final approval, based on the standard processes and procedures, which would have permitted the companies to actually go ahead and conduct the vaccine trial, officials became aware of the negative public reactions and decided to wait.

He said even though the FDA was sure the trials could be carried out safely, it was regrettable that the necessary sensitisation had not been done by the Ministry which led to the consternation from the public.

The FDA, under section eight of the Public Health Act (Act 851) mandates the authority to supervise vaccine trials.

The Production Manager of TV3, Mr Gabriel Bosompem, on whose media outlet Prof Dodoo alleged made the statement that Parliamentarians were ignorant about Ebola disease vaccine trials, also appeared before the Committee for contempt.

Mr Bosompem, who agreed that TV3 was as liable for contempt as much as Prof Dodoo, apologised to the committee its role in the saga.

Prof Dodoo apologized to the Committee and said he had regretted making those statements.

"I will never at any time or point disrespect this great institution of Parliament and indeed members of Parliament. That is not my style, that is not my interest but to the extent that my words or actions or inactions have led to that, I would offer, first to the individual members and the House as a whole and to the good people of Ghana an unqualified apology.

I did make certain comments related to vaccine safety. It would even be paradoxical to be undermining Parliament because I stress a lot on state institutions of which Parliament is foremost," he said.

Chairing the global vaccine safety initiative and working in medicine and vaccine safety for the past 25 years, I have been involved in all the vaccine and medicine trials in this country. One develops the passion to get this work done and the national interest overrules everything," he added.

But to the extent that that national interest has been compromised by the heat generated by those unfortunate comments, once again Mr Chairman and honourable members, I offer a sincere apology to Mr Chairman, the House and the nation," he said.

Mr Ebo Barton-Odro, Chairman of the Committee and First Deputy Speaker of Parliament said the committee would make its report available to the plenary for the House to take a decision on the matter.

GNA