Tobinco and FDA officials prepare questionable GH¢94 million verdict

Herald An investigation into an order issued by the Accra High Court, which ordered the Food and Drug Administration (FDA) to pay a whopping GH¢94 million to Tobinco Pharmaceuticals Ltd for the unlawful destruction of unexpired medicines belonging to Tobinco Pharmaceutical, has revealed ample evidence of allegations of collusion.

The report’s findings suggest that the FDA was simply seeking to settle a questionable judgment debt and should have fought back using available resources, including documents prepared by the FDA’s Chief Executive Officer (CEO), Mimi Delese Darko.

Additionally, Herald discovers that while the problems complained about by Tobinco, led by Samuel Amo Tobbin, occurred in 2013, during Dr. Steph Kwabena Opuni’s administration at the FDA, it went to court in 2019, six years into the current Delese Darko and Nuhu Mogtari government.

Interestingly, Mr. Tobbin, who has had run-ins with stringent FDA regulations over, among other things, the import and distribution of oxytocin, used to induce labor, enhance uterine contractions or control postpartum bleeding, has been seeking damages and interest on drugs confiscated from Tobbin Pharmaceuticals since 2015, when Nuhu Mogtari replaced Dr. Opuni in that role.

Interestingly, Delese Darko, who took over from Mogtari and also worked at the FDA long before Dr. Opuni and Alhaji Mogtari, did not defend the agency’s actions.

Opuni and Mogtari were also not subpoenaed by Justin Agbeli Amenuvor, FDA’s private attorney, to testify in favor of the FDA to save the state from being paid GH¢93,905,760.79 million.

Oddly, the ruling suggested that the FDA had called only one witness, without naming him, but said that on cross-examination the witness “acknowledged that merely because a consumer has experienced negative effects from taking a medication does not mean that the drug is counterfeit.”

It is not clear whether various department heads, some of whom are still employed by the FDA and who participated in the seizure of the unregistered Tobinco drug, appeared in court to testify on behalf of the state. It was also not clear from the verdict that the owners of Bliss GVS Pharma Limited gave testimony on behalf of Tobinco.

However, in a strange turn of events, Heraldcame across fragments of a document prepared by Delese Darko, which disclosed Mr. Tobbin’s testimony given at the FDA headquarters at a hearing regarding the importation of “unregistered artesunate/amodiaquine suppositories into the country.”

A copy of the director general’s document, held by The Herald, stated that “10^t In September 2013, the company’s CEO, Mr. Tobin, received an invitation to a meeting at FDA headquarters to discuss these issues. He accepted with open arms.

“During a meeting with the head of the Department of Narcotics Enforcement, Mr. Tobin admitted to importing unregistered artesunate/amodiaquine suppositories into the country.

“He also admitted that most of the products imported by the Company had expired registrations and others were never registered with the FDA.

“He, however, explained that the Tobinco Pharmaceuticals management has taken the decision to manufacture all imported products locally at Entrance Pharmaceuticals, a sister local pharmaceutical manufacturing company, which is still under construction but is optimistic that it will be ready for production soon, hence the reason for withholding the registration of the products.

“Mr. Tobbin was tasked with withdrawing all Artesunate/Amodiaquine suppositories in the country and initiating the process of registering unregistered products.”

Herald Contact with the FDA revealed that Tobinco’s products were so bad that the company was forced to send back unregistered and unhealthy products to their country of origin.

The article also indicated that the FDA was tired of destroying unhealthy drugs and was also concerned about environmental contamination from toxic gases resulting from the destruction of Tobinco drugs that the company insisted on supplying.

In additionHerald A contact in the National Security Secretariat, also known as “Blue Gate” or “Castle Annex”, also revealed meetings that took place between officials of the pharmaceutical company Tobinco led by Mr. Tobbin, the CEO of Bliss GVS Pharma Limited, SN Kamatha, and FDA officials, during which Mr. Tobbin gave additional testimony.

The meeting at the National Security Secretariat was chaired by the late Kweku Duah Gumwho was deputy to Lieutenant Colonel Larry Gbevlo-Lartey.

Herald the information is that on September 2, 2013, then-Deputy Director General for Safety Monitoring and Clinical Research Delese Darko, now Director General of the FDA, requested the Drug Enforcement Agency to conduct an investigation into Tobbinco’s drugs.

Ms. Darko wanted the FDA to investigate whether the unregistered product Artesunate/Amodiaquine was being promoted and distributed by the Plaintiff, Tobinco Pharmaceuticals.

Ms Darko also wanted the FDA to investigate whether unregistered products were being prescribed by doctors at Kwesimintim Hospital.

This happened after receiving a report from a pharmacist at the Kraspect pharmacy.

The Drug Evaluation and Registration (DER) report of September 6, 2013 showed that out of a total of 103 products, 48 ​​were unregistered, 36 of 103 had expired registration, and 16 were in the process of registration. Only 2 had valid registration.

It is unclear whether this important information was provided to the court, especially since it was done under the direct mandate of the current Director General.

Media reports indicated that in 2014, the Food and Drug Administration confiscated pharmaceutical products imported into Ghana by Tobinco, deeming them unhealthy.

In 2019, Tobinco sued the FDA and asked the court to award the FDA its costs and declare its actions unlawful.

Tobinco, the plaintiff’s creditor in the case, was represented by Mr Philip Addison of Addison Bright Sloane, Barristers, Solicitors, Consultants, Accra.

The court, presided over by Judge Audrey Kocuvie-Tay, issued a ruling in which she found that the wanton destruction of unexpired Tobinco products without obtaining any court order was unlawful.

The court again held that “the FDA’s unlawful closure of Tobinco’s warehouses and the FDA’s negative media publicity resulted in massive expirations of Tobinco products between June 2014 and August 2015.”

Judge Kocuvie-Tay further ruled that the FDA’s decision to prohibit the sale of Tobinco products without obtaining an executive order from the Minister of Health was unlawful.

She stated that the actions of the FDA and its Director General to prohibit Bliss GVS Pharma Limited from importing drugs into Ghana without the issuance of an Executive Order (EI) by the Minister were unlawful.

The judge found that Tobinco did not import counterfeit drugs into the Ghanaian market.

She stated that the unlawful conduct of the FDA and its CEO caused serious harm and loss to Tobinco’s business.

The court found that the FDA’s actions in refusing to register Tobinco’s drugs, confiscating Tobinco’s drugs from customers, issuing an arrest warrant for Tobinco’s CEO, and detaining imported Tobinco drugs at the port of Tema constituted an abuse of the FDA’s statutory powers and duties.

Due to the FDA’s actions which caused losses to Tobinco, the court ordered the FDA to pay special damages in the amount of GH¢24,003,157.20, which was the total cost of Tobinco’s expired products in its warehouses.

The court also awarded special damages in the amount of GH¢511,414.35 to reimburse the plaintiff for downtime expenses.

The court also awarded special damages of GH¢67,300 representing reimbursement of expenses incurred in connection with the operation of the customs warehouses, as well as payment of interest on the above amounts at the prevailing bank rates.

The court found that, although Tobinco had not indicated the dates on which interest would begin to accrue on the various amounts awarded, the evidence adduced indicated the dates on which the breaches and/or losses were identified in the following amounts/reliefs: GH¢24,003,157.20 from January 2015 at the applicable bank rate to the date of final payment and GH¢511,414.35 from November 2015 at the applicable bank rate to the date of final payment.

The court awarded costs of GH¢67,300 from January 2015 at the prevailing bank rate to the date of final payment, in addition to general damages of GH¢5 million against the FDA for the misconduct. The court also awarded costs of GH¢1 million against the FDA in favour of Tobinco.

The remaining amounts include compensation for special damages of GH¢24,003,157.20, GH¢511,414.35 and GH¢67,300.

Tobinco was seeking $147,572.52 as the total cost of goods manufactured by the company that were seized and later destroyed by the FDA.

GH¢511,414.35 for demurrage and GH¢67,300 for customs warehousing.

More coming soon!