• Monday, May 27, 2024
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How international exposure has given NAFDAC’s Moji Adeyeye an edge over the management of regulatory processes and falsified medicines’ vendors

How international exposure has given NAFDAC’s Moji Adeyeye an edge over the management of regulatory processes and falsified medicines’ vendors

By Bashir Ibrahim Hassan

One of the challenges of health care delivery in developing countries is how drugs that are supposed to aid the system turn out to be its major headache. Thus, drug abuse and the proliferation of illicit and fake drugs account for the health challenges in these countries. In economic terms, many of these countries end up spending vast amounts of foreign exchange importing drugs, even when natural resources are available to them to sustain local manufacturing of them.

With her vast academic and professional knowledge of Nigeria’s healthcare delivery system, she navigates the challenges of the system. She saw many decades ago (late 1970s and early 1980s) the pattern of people taking medicines without a prescription while on her internship at UCH and later working as a registered pharmacist at Baptist Medical Centre Ogbomoso, where she oversaw the hospital pharmacy. But, perhaps, the most crucial ingredients in the life story of the former professor of pharmaceutics, manufacturing science, and drug product evaluation at the College of Pharmacy, Roosevelt University in Schaumburg, Illinois, are the odds she faced in the US as a woman, a black person. In her words, she was “a minority of a minority” while studying in the US, in addition to being “a woman, African, and Nigerian.”

Q: “Under her watch, NAFDAC has also begun implementing Good Distribution Practice (GDP), starting with the legal framework by developing a regulation, which it never did in about 25 years of its existence before Prof Adeyeye came on board.”

She was a professor for 30 years in the US and brought to NAFDAC “all the experiences that I had in manufacturing, the clinical trials that I asked my students to do as Professor kind of gelled to get to this place.” But she was jolted by the complexity of the challenge she was going to face. She says, “I never knew what I was coming into. I knew the FDA (the US’s Federal Drug Administration), and I knew what regulation was from outside. But coming here, I had a limited clue plus some published gap analysis on NAFDAC by a United States Pharmacopoeia (USP) study on NAFDAC before my tenure.”

Read also: NAFDAC’s Adeyeye tackles the drug regulation process and quack medicine vendors

When she was appointed the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) in 2017, Moji was presented with a long-cherished opportunity to right the many wrongs she had witnessed, experienced, and been confronted with as she practised her chosen profession. The professor of pharmaceutics, manufacturing science, and drug product evaluation at the College of Pharmacy, Roosevelt University in Schaumburg, Illinois, had worked in Nigeria in Ibadan and Ogbomosho in the present Oyo state before she went to the US for graduate studies.

But the challenges she faced have been daunting. “When I got appointed, I never knew that things were bad—very, very bad. The only thing that was on at NAFDAC was the roof,” she says. “I met a N3.2 billion debt, a staff body that was stunted in their career, but also a divisive environment. I will call it a toxic environment; I was told that there was always one schism or the other. When I got here, there were three or four things that I needed to fix.”

For everything wrong with drug administration in Nigeria that she highlights, she has a painful, tragic personal example to cite. On the prevalence of substandard or falsified medicines, she tells the story of friends who came home a few years before my tenure started in NAFDAC, and their son almost died because they bought an antibiotic that wasn’t working.

On hawking drugs, she recalls that her brother, living in Ijesa, Lagos, died about two and a half years ago from kidney failure. “About a year before he died, he called me and said he had malaria and couldn’t walk when he took medicines,” she narrates. “I thought he had a stroke, but no. I asked him what medicine he bought, and he mentioned it was an antimalarial that happened to be one of the falsified drugs that we were running after; that was what he bought on the street.”

Read also: From N3.2bn debt, NAFDAC became solvent in one year – Moji Adeyeye, DG/CEO

In response to the dire financial state of NAFDAC, Prof Adeyeye led the task of plugging loopholes that were draining the agency’s finances. NAFDAC settled for Zoom meetings “because a lot of money was being wasted on unnecessary travels. We started Zoom in March 2018—even before the pandemic. My staff didn’t like it then but embraced it later, more so during the pandemic.” She also significantly reduced the number of staff that travel with the Director General on international trips. Today, Moji is satisfied with her achievements at NAFDAC, which arose from the development and implementation of five strategic plans, namely: governance, good leadership, use of international best practices, ensuring that substandard, falsified, and counterfeit medicines are mitigated, and instituting financial accountability.

She recounted her success story: “Within a year, we became solvent. We paid the N3.2 billion debt. We denied ourselves so that we could think about how not to owe, and we have been thinking about it since 2017. How do you get strong as a regulatory agency? The regulatory framework must be strong to support whatever you are doing. Within weeks of getting here, we started a quality management system. We trained ourselves for a year and a half. There was a quality management system in the laboratory, but I told them we cannot have a quality management system in one or two units when the others are rotting. It’s a matter of time before it implodes. So, we made it an agency-wide training. We became more customer-focused and agency-minded because the attitude must change. Even now, we’re still going on with that training, despite our certification (ISO 9001). We became audit-conscious in preparation for the WHO global benchmarking tool (GBT). It has nine modules with 276 indicators, and each indicator has recommendations. We had over 860 recommendations to satisfy in 2018. By March 2022, we had cleared all the indicators and satisfied the recommendations.”

She has adopted a multi-faceted approach to the war against falsified drugs, spanning improved pre-shipment testing, laboratories, and reporting. “We have been able to stop 140 products that could have come into the country because our laboratories over there were reporting to us regularly.” Under her watch, NAFDAC has also begun implementing Good Distribution Practice (GDP), starting with the legal framework by developing a regulation, which it never did in about 25 years of its existence before Prof Adeyeye came on board. She encountered and surmounted opposition from other stakeholders in the pharmaceutical sector who said it was not NAFDAC’s duty to do GDP.

Prof Adeyeye strongly believes that local manufacturing, underpinned by a strong regulatory system, holds the key to the availability of quality medicines.

In furtherance of this, NAFDAC has started a Five + Five initiative. This gives importers of drugs five years to start local manufacturing. It arose from a study that revealed that the top five products that are imported are also the top five products that are manufactured in Nigeria. “Why do we need the importation of the same products?” she asks.

The NAFDAC DG is also giving priority to vaccine production and is pleased that “manufacturing of vaccines is already at our doorstep because NAFDAC has reached maturity level 3. Without maturity level 3, no country can produce vaccines. We have been in Level 3 since 2022, and we are going to Level 4. It is a lot of work, but we’re already working. We had to meet up with over 800 recommendations to get to level 3, or about 276 indicators. When I got here, we were at -1. Now we are going to 4 for both medicines and vaccines. There is lots of work, but we will get there.

She calls on the public to support the agency with funding. “For our funding, again, we are not alone. What do other regulatory agencies do? They get funding from the government. There are what are called user fees; these are fees that are paid for inspection, laboratory testing, pharmacovigilance, and post-marketing surveillance. It is deliberately designated for that. Those user fees are supposed to be untouchable; we have not realised this fact as a country.”

She says improved funding will enable the agency to motivate its staff to provide effective regulation in a very sensitive sector.

On people taking drugs without a prescription, Prof Adeyeye calls on the Ministry of Health and the Medical Association to articulate a prescription policy and enforce it to change the narrative. She recalls her days of volunteering at the University of Florida when I first went to the US in the early 1980s, saying, “I volunteered 24 hours a week, and I couldn’t take one paracetamol tablet without a prescription, and I was part of the workforce.” To increase public awareness about its work, the agency started doing “NAFDAC and Your Health,” a twice-a-week programme on television (TVC and NTA).

Read also: NAFDAC recalls J&J’s children’s syrup over toxicity

Daring to take risks has always been the lot of the woman, dating back to her formative years. “People thought I was crazy because I was coming from the West to the Southeast just after the war,” she recalls, adding: “That was where life started shaping me—opportunities and challenges—because it was not just going to another side of the country, but going after the war. In my auditorium, where we take lectures, there were no seats. The Faculty of Pharmacy was one long, narrow room where the dean and the few professors that we had were, and there were a few extra chairs. So, you had to rush to get the chairs that you carry physically to the auditorium.

From my time at Nsukka, I learned that I could live with any group of people in the world despite the associated risks. God has a way of bringing you into a very challenging situation to prove whether you’re going to make it or not. But it was a very good experience for me. We didn’t have enough teachers. We had teachers coming from the University of Ibadan.”

She would like to leave behind a NAFDAC that, in 10 years, will have three times the current staff strength with better emoluments, a NAFDAC that is technologically driven, in which the interaction between man and man will have been reduced, and in which compromise will be reduced. “I want to see a NAFDAC that has no silo mentality but has fully embraced team efforts.”