When two elephants fight • The case between FDA and Tobinco
The Food and Drugs Authority (FDA), formerly the Food and Drugs Board (FDB), was established in August 1997.
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It is the national regulatory authority charged with the regulation of food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products.
The FDA 's legal mandate is found in Part 6 (Tobacco Control Measures), Part 7 (Food and Drugs), and Part 8 (Clinical trials) of the Public Health Act, Act 851 of 2012.
It is an agency under the Ministry of Health with an 11-member governing board inclusive of the chief executive officer(CEO), who is responsible for the day-to-day administration of the FDA .
The importance of the FDA to our socio-economic life cannot be downplayed.
It ensures that unwholesome products do not find their way into our markets. In effect, it works to ensure the safety of the public.
Despite their efforts, our markets are not free from all kinds of fake products.
For instance,the authority is yet to find the means of getting rid of expired flour which is used to make doughnuts, or sugar which is tied in little polythene bags with no expiry dates displayed.
From time to time, the authority alerts the public about some drugs and foods which it finds unwholesome or which it thinks are of questionable nature and must, therefore, not be patronised by the public.
The FDA, being a statutory institution, is serviced by the public purse. Thus, it is the Ghanaian taxpayer’s resources which services the organisation by way of paying its staff and providing the necessary logistics for its operations.
This being the case, one would have thought that as a people, we would be interested in empowering the FDA to discharge its duties instead of merely adding to the several state institutions which just exist by name and hardly make any impact on our socio-economic lives.
And yet what do we see? In the case between the FDA and TOBINCO, society, including some prominent citizens, seem to have bought into TOBINCO’s case without taking a deeper look into the matter. It is on record that even the President and Parliament have been called upon to intervene.
My question is: Must the President really come into this when we have, as a people, identified the strengthening of our state institutions as a way of developing our country?
The case is that the FDA advised against the patronage of an anti-malaria medicine for children called GSUNATE Plus, a suppository drug made up of a combination of Artesunate 25mg and Amodiaquine 75mg.
The medicine was manufactured in India by a company called BLISS GVS PHARMA LTD and was imported and distributed by TOBINCO.
The then Chief Executive of the FDA, Dr Stephen K. Opuni, warned that no clinical trials had been conducted on that product and that its efficacy through the rectal route had not been established, therefore, treating malaria in children with that drug could lead to therapeutic failures with complications.
We already know how devastating malaria is and if we come to think of the fact that children are vulnerable, the issue must be taken with all seriousness.
We, therefore, need to go beyond sentimentalism and deal with the issue dispassionately. For instance, has TOBINCO broken any rules? And if it has, are there sanctions?
Issues such as TOBINCO being a local company and, therefore, it must be encouraged to grow, may be good but must it be at the expense of our health?
Have we sat down to think of where we would have been without an albeit limping FDA? Does worm-infested biscuits ring a bell in anybody’s ears?
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It is a similar attitude we adopt when we look on for traders to take over pavements and when the city authorities want to ensure that sanity prevails (never mind that they watched them take over the pavement), some members of the public join the offenders to protest, saying their livelihood is being taken away from them.
All over the world, businesses exist to make profit and I think TOBINCO is no exception, irrespective of the fact that it may be involved in some charity works.
The same motivation that, for instance,makes the tobacco company advertise its products knowing very well that its products are harmful to society, is what makes the gari seller hit the under of her olonka to ensure that it contains less gari or the kenkey seller use several leaves to ensure the consumer gets a smaller size of kenkey or worse still, the powdered pepper seller add the seed of avocado to the dried pepper before grinding to increase the amount without thinking of the effect the pear seed could have on the consumer. Subterfuge is the name.
TOBINCO is an organisation being run by mortals like us and not angels, and is motivated by several things including profit.
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This is why I would recommend an independent investigation into the issues and whoever is at fault is brought to book. This is a catch 22 situation because TOBINCO is an indigenous company that must be encouraged to grow.
In a similar vein, FDA is a national asset set up to perform a critical function and we cannot by our acts or omissions let it collapse. Of course, we do so at our peril.
The news that the CEO of FDA,Mr Opuni,has been removed from office in the heat of the TOBINCO impasse is worrisome. With his removal, does it mean that the drugs imported by TOBINCO were safe? Without the issues being made clear, I don’t know how the former CEO will be energised to ensure that he works to the best of his ability wherever he has been sent.
It should not be lost on us that we cannot develop on the back of non-functioning state institutions.
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Writer’s email: doreen.hammond@graphic.com.gh