World Health Organization forces FDA to suspend approval of Tobinco drugs

…insists that its activities pose a threat to the “public, health and safety.”

The Food and Drugs Authority (FDA) has suspended the operations of the Entrance Pharmaceutical and Research Centre, owned by Tobinco Pharmaceuticals Ltd, for non-compliance with the World Health Organization (WHO) guidelines for good manufacturing practices.

The Heraldhas reviewed a letter dated July 1, 2024, written and signed by FDA Chief Executive Officer (CEO), Dr. Mimi Delese A. A Darko, advising the Acting Director that “the safety, quality, and effectiveness of general and beta-lactam drug products manufactured at your facility pose a threat to the public, health, and safety.”

“You are hereby directed to cease all manufacturing activities and to submit a Corrective and Preventive Action Report (CAPA) within fifteen (15) days of receipt of this letter,” the FDA chief demanded, among others, from the manufacturers of the blood tonic and multivitamin preparation Foligrow, Entracin, Entradol, Zinvite, Lufart, Artenate, Tobin’s Baby Grip Water, Entrance Antacid, Tobvital Multivitamin, Lonart, Coldrilif, Tobcee Syrup and Antralyn Baby.

The suspension followed a routine inspection of the Entrance Pharmaceutical and Research Centre facility “at 16 Okpoi Gonno 1 Light Industrial Area, Accra” by the Food and Drugs Authority from June 24 to 26, 2024. The aim was to determine the level of compliance with Good Manufacturing Practices (GMP)”, during which “certain deficiencies were identified”.

Interestingly, FDA officials have been on site at the Pharmaceutical and Research Centre since Friday last week, inspecting the company’s operations to ensure that it complies with the required WHO standards.

FDA, The Heraldhad the WHO breathing down its neck to ensure that the health, lives and safety of Ghanaians, including children, were not endangered by Tobinco and its sister company.

The company is said to have initially defied the FDA’s order and refused to cease operations.

The FDA found in its 10-page report that the Entrance Pharmaceutical and Research Centre’s activities did not meet the required safety, quality and effectiveness and that the “generic and beta-lactam drugs manufactured at your facility pose a threat to the public, health and safety.”

“The plant’s deficiencies, categorised as 5 ‘critical’, 39 ‘serious’ and 5 ‘other’ deficiencies, have rendered the plant non-compliant with WHO guidelines for good manufacturing practice,” adding: “Please treat this as urgent and adhere to the guidelines.”

FDA leadership is expected to update WHO on its latest findings regarding the company.

The Herald The ongoing investigation into the Accra High Court’s order that the FDA pay the hefty sum of 94 million cedis (about 121 million euros) to Tobinco Pharmaceuticals Ltd. for the illegal destruction of drugs in the company’s possession that were not yet expired is bringing more and more dirt to light and confirming that Tobinco deserves no money whatsoever.

A crucial document in the care of The Heraldfrom 6.^, In February 2017, the FDA’s current CEO insisted that Tobinco’s conduct was punishable under the law, specifically the Public Health Act 2012, Act 851. However, it remains unclear why she did not take the stand to testify on behalf of the agency in the 2013 incident.

Ms Darko’s condemnatory letter was in response to a letter dated January 31, 2017, from Akufo-Addo, Prempeh & Co, the law firm of President Nana Akufo-Addo, strongly condemning Dr Stephen Kwabena Opuni for taking action against medicines imported into the country by Tobinco Pharmaceuticals Ltd, owned by Samuel Amo Tobin.

Twenty-four days after the Akufo-Addo government came to power, Akufo-Addo, Prempeh & Co., represented by one Alex Mantey Osei, acting as lawyers for Tobinco Pharmaceuticals Ltd., reignited the four-year-old conflict between the FDA and Tobinco, accusing Dr. Opuni of cruelty and “brutal harassment” of Tobinco employees in connection with the “illegal destruction of the imported drugs.”

In the letter demanding compensation, Tobinco’s lawyer stated that Dr. Opuni “categorically threatened to bring down our client’s CEO” and “to finish him off like Semanhyia” etc.”

However, in her response to the letter, Delese Darko said that according to documents in her possession, The Herald, The author, who turned out to be the mastermind behind the discovery of Tobinco’s unapproved products in 2013, fired back on behalf of the FDA, stating that it “denies the allegations contained therein and, in response, states that its actions and activities did not cause your client any loss or damage during the period in question.”

“For the avoidance of doubt, FDA wishes to state that your client, in blatant disregard of national laws and in particular the Public Health Act 2012 (Act 851), has endangered the health and safety of Ghanaians, and in particular the health of Ghanaian children, by importing, distributing and offering for sale counterfeit, substandard and unregistered medical devices.”

She further urged the attorney to “note that the law criminalizes the above-mentioned conduct and empowers the FDA to act promptly and in a timely manner in such cases to avert any danger to the public.”

“We firmly believe that FDA, through its officials, acted properly, diligently, and in accordance with due process, and in the reasonable belief that its failure to act accordingly would endanger public health and safety.”

“We wish to expressly state that FDA owes your client no debt, whether in contract, tort or otherwise,” concluded Ms. Dakos’ letter. She was CEO of FDA at the time.

Meanwhile, analysts have looked at the 94 million cedis (about 121 million euros) awarded to Tobinco and believe that this grant would hinder the work of the FDA.

It was explained that FDA has always and continues to safely dispose of unregistered and/or expired products under Section 132(2) without a court order, using guidelines set out in Section 148(2)(f) – Guidelines for the Destruction of Drug Products.

It is believed that the ruling will open a Pandora’s box for all divestitures made without a court order since the FDA’s creation to challenge judgments based on the court orders contained in the ruling.

The FDA (acting through authorized officers) has power under section 135 to enter any premises where an officer believes that a regulated product is being kept, stored or transported; (d) to seize and detain for such period as the officer may consider necessary any article by or in respect of which any provision of Act 851 is alleged to have been contravened.

FDA’s powers also include the ability to detain unregulated items on the owner’s or importer’s premises. Section 132(1) – FDA has the power to order the closure of premises.

Therefore, it must be of interest to the public to know whether the FDA, through its officials, acted unlawfully during the reporting period in the interest of public health and safety or in accordance with the judgment.

The newspaper concluded that the FDA was merely trying to settle a dubious claim arising from a court judgment, when it should have fought it with the tools at its disposal, including documents written by FDA chief Delese Darko.

Additionally, The Herald notes that although the problems complained of by Tobinco under the leadership of Samuel Amo Tobbin arose as early as 2013 during Dr. Opuni’s tenure at the FDA, he did not go to court until 2019, six years into the current tenure of Delese Darko and after Alhaji Hudu Mogtari.

Interestingly, Mr. Tobbin, who has had several previous run-ins with the FDA’s strict regulations, including in connection with the importation and distribution of oxytocin, which is used to induce labor, enhance uterine contractions or control bleeding after delivery, sought damages and interest for drugs confiscated from Tobinco Pharmaceuticals starting in 2015 during the tenure of Hudu Mogtari, who replaced Dr. Opuni.

Notably, Delese Darko, who succeeded Mogtari and also served at the FDA long before Dr. Opuni and Alhaji Mogtari, did not defend the institution’s actions.

Nor were Opuni and Mogtari subpoenaed by Justin Agbeli Amenuvor, the FDA’s private counsel, to testify in favour of the FDA and save the state from paying GH¢93,905,760.79 million.

Attorney Philip Addison of Addison Bright Sloane, Barristers, Solicitors, Consultants, formerly of the Akufo-Addo law firm, represented Tobinco in the case presided over by Justice Audrey Kocuvie-Tay.

There’s more to come!