The High Court in Accra, in a ruling dated July 29, 2024, ordered the Food and Drugs Authority (FDA) to pay a colossal amount of GH¢94 million to Tobinco Pharmaceuticals Ltd for the unlawful restriction and destruction of drugs belonging to the pharmaceutical company.
The court ruled on a suit filed on July 19, 2019, by Tobinco Pharmaceuticals against the FDA. The company accused the agency of abusing its statutory powers when it confiscated and destroyed its drugs between September and December 2013.
Tobinco sought damages, and the court, presided over by Her Ladyship Audrey Kocuvie-Tay, ruled in its favour, ordering the FDA to pay the pharmaceutical company GH¢93,905,760.79 for the unlawful destruction of unexpired drugs belonging to Tobinco.
An investigative report by The Herald newspaper has found some supposed rots in the Tobinco vs FDA case, pointing to allegations of collusion between the company and the authority for the GH¢94 million judgment debt.
Details of the findings of the paper, which were published on theheraldghana.com, raises several inconsistencies which have been heightened by the question, Why did Tobinco wait till 2019 to file his complaint?
One of the major inconsistencies pointed out in the report was the timing of the suit by Tobinco, led by its group chairman, Samuel Amo Tobbin.
Even though the company said its drugs were illegally seized and destroyed by the FDA under the reign of Dr Opuni, it waited to file a suit 6 years after the incident.
Tobinco did not sue the FDA even after Dr. Opuni left in 2013 and Nuhu Mogtari was appointed Chief Executive Officer. The company also took no action under Mogtari's reign but only decided to act when Dr. Delese Darko was in charge.
“Additionally, The Herald discovers that, although the issues Tobinco, led by Samuel Amo Tobbin, complained of happened in 2013 during the Dr Stephen Kwabena Opuni administration at FDA, he rather went to court in 2019, six clear years under the current Delese Darko administration and after Nuhu Mogtari,” part of the report reads.
Why is the company seeking compensation from 2015, not 2013, when the goods were confiscated?
Another timing issue the investigative report found was the reliefs sought by Tobinco.
Even though the company's goods were confiscated in 2013 under the reign of Dr Opuni, it sought damages and interest on its medicines confiscated starting from 2015, during the tenure of Nuhu Mogtari.
“Interestingly, Mr Tobbin, who has had various brushes with the FDA’s strict regulations, including the importation and distribution of Oxytocin used to induce labour or strengthen uterine contractions, or to control bleeding after childbirth, sought damages and interest on medicines confiscated from Tobin Pharmaceuticals starting from 2015 during the tenure of Nuhu Mogtari, who replaced Dr Opuni,” the report indicated.
Who is the witness that was called in the court case?
The report also accused the FDA, under the leadership of Dr Delese Darko, of failing to use all the arsenals at its disposal to defend itself during the trial.
It said that the company only presented one witness during the trial and did not even invite Dr Opuni or Mogtari, under whose leaderships the suit covers.
“Remarkably, Delese Darko, who took over from Mogtari and had also been at the FDA long before Dr Opuni and Alhaji Mogtari, did not defend the institution’s actions. Neither were Opuni and Mogtari subpoenaed by Justin Agbeli Amenuvor, FDA’s private lawyer, to give evidence in favour of the FDA to save the state from the GH¢93,905,760.79 payment.
“Strangely, the judgement suggested the FDA called only one witness, without giving his or her name, but said that during cross-examination the witness 'admitted that merely because a consumer experienced adverse effects from taking medications, it does not make the drug fake,'” part of the report reads.
The report also indicated that it is unclear whether the FDA allowed its senior officers (including the current CEO) who are privy to the Tobinco case to testify during the trial and why Dr. Opuni wasn't subpoenaed to give evidence in the FDA's defence of the public purse.
So, the question remains, who is this witness?
What informed the change in position of the FDA boss in what she said to the BNI in 2015 and now?
The Herald also stated that it found excerpts of a document prepared by Delese Darko which revealed the confessions of Tobbin when he was summoned to the FDA headquarters for questioning on the importation of “unregistered Artesunate/Amodiaquine suppositories into the country.”
The excerpts of the document were quoted as follows:
“On the 10th September, 2013 an invitation for a meeting at the FDA Head Office on the issues was extended to the Chief Executive Officer of the Company, Mr Tobbin, which he honoured.
“In the meeting with the Head of Drug Enforcement Department, Mr Tobbin admitted importing the unregistered Artesunate/Amodiaquine suppositories into the country. He also admitted that most of the products imported by the Company had expired registration, whilst others were never registered with the FDA.
“He, however, explained that the Management of Tobinco Pharmaceuticals had decided to manufacture all the imported products locally at Entrance Pharmaceuticals, a sister local pharmaceutical manufacturing company which was still under construction, but was optimistic would soon be ready for production, hence the reason for holding on with the registration of the products.”
It concluded, “Mr Tobbin was tasked to recall all the Artesunate/Amodiaquine suppositories in the country and to initiate the registration process for the unregistered products.”
The paper also stated that its sources at the FDA indicated that the pharmaceutical company was forced to ship back its unregistered and unwholesome products to the country of origin because the FDA got tired of destroying them and it also feared polluting the environment with poisonous gases coming from the destruction.
What is the quantity of drugs Tobinco imported and what quantity was not good?
The Herald’s investigation also found that Dr Delese Darko, when she was Acting Deputy Chief Executive in charge of Safety Monitoring and Clinical Trials, ordered investigations on Tobinco’s drugs.
She wanted the FDA to verify whether the unregistered product Artesunate/Amodiaquine was being promoted and distributed by Tobinco Pharmaceuticals and also to verify whether the unregistered products were being prescribed by doctors at the Kwesimintim Hospital.
A report of Drug Evaluation and Registration (DER), which is dated September 6, 2013, “showed that out of 103 products of Tobinco, 48 were unregistered, 36 out of the 103 had expired registration and 16 were pending registration. Only 2 had valid registration.”
The report indicated that it is unclear whether this report was presented to the court by the FDA.
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