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Opinions of Wednesday, 2 February 2011

Columnist: Amevor-D, D. E.

Opuni's FDB-Protecting Public Health or collapsing businesses

DR. OPUNI'S FDB-PROTECTING THE PUBLIC HEALTH OR COLLAPSING HERBAL INDUSTRY
The law setting up the Food & Drugs Board (FDB) mandated it to regulate and
control the importation, exportation, manufacture, advertisement, distribution,
sale and use of food, drugs, cosmetics, medical devices, herbal medicine,
bottled water and chemicals, this implies that any person wishing to engage in
any of the above activities must require the Board’s approval.

FDB Mission Statement
“The FDB is responsible for protecting the public health by assuring the safety,
efficacy, and security of human and veterinary drugs, biological products,
medical devices, our nation’s food supply, cosmetics, and products that emit
radiation. The FDB is also responsible for advancing the public health by
helping to speed innovations that make medicines and foods more effective,
safer, and more affordable; and helping the public get the accurate,
science-based information they need to use medicines and foods to improve their
health.”

A strong Food and Drug Board (FDB) is crucial for the health of our country. The
benefits of a robust, progressive Agency are enormous; the risks of a
debilitated, under-performing organization are incalculable.

The FDB constitutes a critical component of our nation’s healthcare delivery and
public health system. The FDB, as much as any public or private sector
institution in this country, touches the lives, health and wellbeing of all
Ghanaians and is integral to the nation’s economy and its security.

The FDB’s responsibilities for protecting the health of Ghanaians are
far-reaching. The FDB protects our nation’s food supply through regulatory
activities designed to cover 80 percent of the food consumed in this country.
The FDB also regulates all drugs, human vaccines, and medical devices, and hence
plays a critical role in ensuring the appropriate safety and efficacy of rapidly
emerging medical products

The FDB is also central to the economic health of the nation, regulating
approximately $1 billion in consumer products or 25 pesewa of every consumer
cedi expended in this country annually. The industries that FDB regulates are
among the most successful and innovative in our society, and are among the few
that contribute to a positive balance of trade with other countries.

The importance of the FDB in the nation’s security is similarly profound. The
FDB plays a central role in protecting the nation from the potential effects of
terrorist attacks1, such as anthrax, smallpox, attacks on the food supply, nerve
agent attacks and radioactive contamination, as well as from naturally occurring
threats, such as SARS, West Nile virus and avian influenza.
ADMINISTRATIVE DETENTION OF DEVICES
Purpose
This section provides the procedures and defines responsibilities for the
Administrative Detention of Devices and Products.
Detention of Products & Devices
Background
The Act authorizes the FDB to detain products & devices intended for human use
if, during an inspection/investigation, the FDB has reason to believe the
products or devices are not registered, adulterated or misbranded. The intent of
administrative detention is to protect the public by preventing distribution or
use of violative products/devices until FDB has had time to consider the
appropriate action to take and, where appropriate, to initiate a regulatory
action. The action of choice, in most cases, is a seizure.

Detention Order Issuance

An investigator or other authorized agent signs the order. Issue the order in
writing to the owner, operator, agent, or other responsible person in charge of
the place where the device is located.


The thrust of FDB’s mandate is to safeguard the health of the nation and the
only way to actualize this mandate is ensure that the people at the grassroot
level are adequately covered as stipulated in PNDCL 305B Section 18(1). The
Board thus require the active participation of everyone to achieve its mandate.

REVIEW OF FDB ACTIVITIES
The popular adage that it takes an action to turn dreams into realities cannot
be more apt in describing the gains recorded so far by the Food & Drugs Board,
Ghana (FDB).

Enhanced Corporate Culture/Image
The greatest achievement of the FDB is the institutionalization of a culture
that promotes transparency, accountability, hard work and abhors corruption. It
has brought about behavioural change in the staff.

FDB’s commitment to transform the culture of corruption and prosecute the war
against counterfeit, fake drugs, and unregistered products including herbal
medicine making unbelievable claim was indeed the oil that lubricated the wheel
of its success.
Transparency in the regulatory processes has helped in its communication with
stakeholders and made it effective and fruitful. FDB’s anticorruption stance has
brought support for the board and Ghana and it has helped it to achieve
effective regulation in Ghana.
The public enlightment campaigns and other strategies bore much fruit because
the Government, the Press and the Ghanaian Public unwaveringly supported FDB.
The management style of the Board in Ghana must be emulated by other government
agencies (Utility Regulatory Commission, Ghana Standards Board, Environmental
Protection Agency, Lands Commission, Revenue Commission, etc) because the
remarkable paradigm shift has become an inspiration to others in Public Service.
The Daily publication titled “FDB as a study in management” asserts that FDB’s
transformation should make a rewarding study to students of management and
leadership. To crown it all, the Board has been shortlisted by the Consumer
Advocacy Platform as the 1st among the Best Consumer Sensitive Government
agencies.

Growth in the Health and Pharmaceutical sub-sector
In the typical formula of reform agenda, we assume that the private sector is
the engine of growth. FDB’s reform in the pharmaceutical sector has shown that
while the private sector is the engine, the public sector indeed oils this
engine without which the former crashes.

The credit for the improved profile of the FDB can be attributed to the untiring
efforts of the CEO, Dr. Stephen K. Opuni and the enthusiastic workforce,
manufacturers and pro-active government policies (Ministry of Health). These
have led to a tremendous increase in production capacities of the local
pharmaceutical industries as reported by individual manufacturers.

Some of the activities/investigations carried out by the FDB include;
· Change of the expiry date of expired Chinese herbal products-Quloon
· Importation of unregistered medical devices and products Tianshi,
Meilun and Tasly
· Importation and distribution for sale of sanitary pads purporting to
treat kidney failure, etc-Anion
· Herbal preparation for the treatment of AIDS
· Manufacture of unregistered herbal products purporting to treat
schedule II diseases- Sharp Sharp, Se Menhyia, Kingdom, Malarigo, etc

· Counterfeit of dailin, Coartem, Augmentin, etc
The improved performance of the sector can be attributed to strict import
inspection policy, living up to its strict compliance to product regulation and
the new impetus from the Post Market Surveillance department of FDB, which has
seriously curtailed dumping. The vigorous onslaught of FDB on fake and
substandard products has pushed the capacity utilization in the economy.
FDB activities, therefore has reinforced the confidence of investors in the
Pharmaceutical industry, as evidenced continuous upward movement in the share
price of Pharmaceutical companies on the Ghana Stock Exchange.

Many international agencies have extolled the FDB over rise in confidence in
healthcare in Ghana through the Boards sustained fight against faking and
counterfeiting of regulated products. This in turn is believed to have
encouraged the standardization of the products, leading to recovery of lost
market share. It has also brought the need to rehabilitate, expand and modernize
the companies’ plants, the possibility of opening new product lines and
diversification to capture new markets. The success of the agency in controlling
the importation of regulated products, beefing up surveillance at the ports,
clamping down on major sources of fake, unregistered and substandard drugs both
locally and internationally has impacted positively on the healthcare sector.
Many companies doing genuine business have returned to profitability and have
become key players in the sector.

The Board’s reform has led to other West African and European countries not to
make mention of Asian and American states renewed confidence and increase
patronage of products from Ghana.

Increased Public Awareness
The public awareness created regarding FDB’s regulatory activities, especially
those activities relate to fake and counterfeit drugs, resulted in the
participation of the regulated industries, consumers and other stakeholders in
the promotion of food and drug regulation in Ghana.
These achievements, among others have awakened consciousness that Ghana is no
longer a dumping ground for fake drugs, and other substandard regulated products
including “aphrodisiac” and unregistered herbal products. There is an
encouraging level of compliance to FDB’s ban on the importation of counterfeit
and other substandard pharmaceutical products due to the commitment of importers
to comply with the FDB directives. The consciousness and alertness of both the
consumer and stakeholders are also heightened, particularly the dangers posed to
health by substandard products. The activities of FDB have been rated by many
Ghanaians as excellent. Consumers have now formed the habit of scrutinizing
their drugs, food and other regulated products for genuineness by checking the
expiry dates and other valuable information before purchase and use. That is
remarkable.
Manufacturers and importers are encouraged to bring to the attention of FDB all
discovered cases of faking of their registered products for prompt and
successful investigation, publication and possible prosecution as stipulated in
the food and drugs law.
Manufacturers and importers of unregistered products are spurred by FDB’s
publications of unregistered products to submit their products for registration,
knowing fully well the negative impact such adverse publicity will have on their
products and organizations.
FDB’s staffs enjoys high esteem, perception and goodwill from the Ghanaian
public and consumers who are in better in position to appreciate that fact FDB
is focused on the promotion of good health rather than being a punitive body.
The international community is not left out on this increase awareness on the
activities of FDB. An excerpt of a correspondence during a conference in the USA
on the counterfeit drug reads in part...
I am pleased to report that in planning for the conference, praise for FDB and
Dr. S.K. Opuni has been universal. Everyone is very impressed with FDB’s efforts
and tenacity and for that reason we would like to highlight FDB during every
conference as a model for other countries in Africa which are trying to win the
battle against counterfeit drugs.....Victor L. Kumington, Office of Enforcement,
USA.

IMPROVED OUTPUT
From April 2009 to November 2010, the Board carried many publicised destruction
exercise of counterfeit and substandard products including herbal.

CONCERN
The question we ask is what is happening in the Food directorate with the many
unhealthy packaged water and unwholesome food products both locally manufactured
and imported into the country. The least said about the various hotels and
restaurants, the better.


The science at the FDB is in a precarious position: the Agency suffers from
serious scientific deficiencies and is not positioned to meet current or
emerging regulatory responsibilities.

The deficiency has two sources:
???? The demands on the FDB have soared due to the extraordinary advance of
scientific discoveries, the complexity of the new products and claims submitted
to FDB for pre-market review and approval, the emergence of challenging safety
problems, and the globalization of the industries that FDB regulates.

???? The resources have not increased in proportion to the demands. The result is
that the scientific demands on the Agency far exceed its capacity to respond.
This imbalance is imposing a significant risk to the integrity of the food,
drug, cosmetic and device regulatory system, and hence the safety of the public.


It is further noted that the impact of the deficiency is profound precisely
because science is at the heart of everything FDB does. The Agency will flounder
and ultimately fail without a strong scientific foundation. That foundation
rests on three pillars. The first pillar is strong selective scientific research
programs that are appropriately mission-supportive, in all areas of FDB
responsibility. This research is critical because it is not conducted by other
public or private entities, but is fundamental to the discharge of FDB’s
statutory responsibilities to protect and promote the public health. The second
pillar is excellent staff with cutting-edge scientific expertise appropriate to
the mission. This expertise includes the ability to access, understand and
evaluate science; effectively apply this science to the regulatory process; and
communicate the implications of its findings for product safety and efficacy to
the public. The third pillar is an information infrastructure and processing
capability that ensures the FDB has access to the best data and information
necessary to support the regulatory science required to fulfil FDB’s mission.

“the term “science” broadly to encompass all of the disciplines and activities
within the FDA that have a scientific basis, e.g., research, review of submitted
applications and petitions, development of scientific policy, guidelines and
procedures, and the analytical and inspection responsibilities of the office of
regulatory affairs. “

The FDB cannot fulfill its mission because its scientific base has eroded and
its scientific organizational structure is weak.

The nation’s food supply is at risk. FDB’s ability to develop the science base
and infrastructure needed to efficiently support innovation in the food
industry, provide effective routine surveillance, and conduct emergency outbreak
investigation activities to protect the food supply.

FDB’s inability to keep up with scientific advances means that Ghanaian lives
are at risk. While the world of drug discovery and development has undergone
revolutionary change — shifting from cellular to molecular and gene-based
approaches — FDB’s evaluation methods have remained largely unchanged over the
last half century. Likewise, evaluation methods have not kept pace with major
advances in medical devices and use of products in combination.

Due to constrained resources and lack of adequate staff, FDB is engaged in
reactive regulatory priority setting or a fire-fighting regulatory posture
instead of pursuing a culture of proactive regulatory science. The FDB cannot
adequately monitor development of food and medical products because it is unable
to keep up with scientific advances. The following eight emerging science and
technologies that are most challenging the FDB: systems biology (including
genomics and other “omics”), wireless healthcare devices, nanotechnology,
medical imaging, robotics, cell- and tissue-based products, regenerative
medicine, and combination products. Each of these emerging areas is developing
at an exponential rate and each generates novel scientific, analytic, laboratory
and/or information requirements. The FDB cannot fulfil its surveillance mission
because of inadequate staff and IT resources to implement cutting-edge
approaches to modelling, risk assessment and data analysis. The FDB lacks a
coherent scientific structure and vision as a result of weak organizational
infrastructure. Strong scientific leadership is needed at all levels to develop
a new vision to build a strong science base within the Agency, and in parallel,
this leadership must establish optimal mechanisms to access the best scientific
knowledge and expertise from throughout the government, academia and industry.
Consistent and rigorous peer reviews of programs and processes, which are
currently lacking, are critical for wise utilization of resources and for
rebuilding the Agency’s ability to implement its science-based regulatory
responsibilities effectively.

The FDB cannot fulfill its mission because its scientific workforce does not
have sufficient capacity and capability.

Despite the significant increase in workload during this year, the number of
appropriated personnel remained essentially the same — resulting in major gaps
of scientific expertise in key areas. More importantly, despite the critical
need for a highly trained workforce to fulfil its mission, the FDB faces
substantial recruitment and retention challenges. There are insufficient
programs of measurement to determine worker performance. There is insufficient
investment in professional development, which means that the workforce does not
keep up with scientific advances. Finally, for various reasons, the FDB does not
have sufficiently extensive collaboration with external scientists, thus
limiting infusion of new knowledge and missing opportunities to leverage
resources. One may ask how a technical institution like the FDB has more staff
in its administration than the technical staff.
FDB’s failure to retain and motivate its workforce puts FDB’s mission at risk.
Inadequately trained scientists are generally risk-averse, and tend to give no
decision, a slow decision or, even worse, the wrong decision on regulatory
approval or disapproval. The shortage of science staff (due to lack of resources
to hire) and the inability to recruit and retain needed expertise are serious,
longstanding challenges. Internal expertise and experience to provide the
science capability and capacity needed in highly specialized and fast-evolving
areas is disturbingly limited. The lack of a trained workforce means that the
FDB is ineffective in responding to emerging fields that require individuals and
work teams with multidisciplinary skills built on very complex, highly
specialized, often esoteric bodies of knowledge.

The FDB cannot fulfil its mission because its information technology (IT)
infrastructure is inadequate.
The IT situation at FDB is problematic at best — and at worst it is dangerous.
Many of the FDB systems reside on technology that has been in service beyond the
usual life cycle. Systems fail frequently, and even email systems are unstable.
More importantly, reports of product dangers are not rapidly compared and
analyzed, inspectors’ reports are still hand written and slow to work their way
through the compliance system, and the system for managing imported products
cannot communicate with Customs and other government systems (and often miss
significant product arrivals because the system cannot even distinguish, for
example, between road salt and table salt).

There are inadequate emergency backup systems in place. Critical data reside in
large warehouses sequestered in piles and piles of paper documents. There is no
backup of these records, which include valuable clinical trial data. The FDB has
inadequate extramural funding programs and collaborations to accelerate the
development of critical health information exchanges in order to support
clinical trials and pharmacovigilance activities.

WAY FORWARD
FDB’s resource shortfalls have resulted in a plethora of inadequacies that
threaten our society — including, but not limited to, inadequate inspections of
manufacturers, a dearth of scientists who understand emerging new technologies,
inability to speed the development of new therapies, an import system that is
badly broken, a food supply that grows riskier each year.

We can conclude that FDB can no longer fulfill its mission without substantial
and sustained additional appropriations. The current gaps are due to chronic
underfunding of the Agency, and if these gaps are not addressed immediately, FDB
is in jeopardy of losing its remaining dedicated staff. The extraordinary
efforts of these committed FDB staff members are the very reason further
catastrophic food and drug events have been averted.
Although there is indeed great urgency to stem the tide of continued
deterioration in the science that supports the regulatory decisions of the FDB,
the magnitude of changes that are needed will require a phased approach based on
a well-thought-out plan. Strategic plans must be developed within a strengthened
science organization, as recommended in this article. Recruitment of outstanding
talent with up-to-date skills will also take time. However, there must be an
immediate commitment to make the needed investments in order to recruit the most
outstanding talent. It will be difficult, if not impossible; to recruit the best
leaders unless there is assurance that adequate resources and staff will be
available to address the challenges.

The magnitude of the resources required to restore scientific capability and
capacity is substantial.

We recognize that adequate resources — human and financial — alone will not be
sufficient to repair the deteriorating state of science at FDB, which is why we
also recommend significant restructuring. But without a substantial increase in
resources, the Agency is powerless to improve its performance, will fall further
behind, and will be unable to meet either the mandates or the expectations of
the Ghanaian public. This will damage not only the health of the population of
the Ghana, but also the health of our economy
Upgrade of the Boards laboratories to international standards to yield
international accreditation.
Establish an ultra modern mycotoxin laboratory to ensure that food products meet
all sanitary and phytosanitary conditions. This will help improve the reputation
of Ghana as a reliable supplier of good quality food products to the global
market.
Equip offices with computers and other communication accessories necessary for
good data processing with appropriate vehicles for more effective monitoring and
control of regulated products in the country.

PUBLIC ENLIGHTMENT
Run public enlightment jingles cast in English language and vernacular versions
on regional radio stations. The Body may also consider TV and radio weekly
discussion programmes.
Billboards may be erected in strategic parts of the country. Posters and
stickers warning against the health hazards of fake drugs and substandard
products may be circulated nationwide. The body can also publish bi-annual news
magazine and consumers safety bulletin.

CAMPAIGNS
Organise the following workshops;
* For Patent medicines dealers
* For Drug importers
* For National Union of Road Transport Owners and Workers
* Licensed Clearing and Freight forwarders
* For herbal medicines practitioners of Ghana
* For cosmetic manufacturers
* For Security Agencies staffs-CEPS, Police, Immigration, etc

REGULAR PUBLICATION OF FDB LIST OF IDENTIFIED FAKE PRODUCTS
To create awareness that will render the distribution of such products
ineffective.

* Engage in periodic publication of blacklisted companies, both local and
international who do not conform to WHO certified GMP or produces
substandard products to warn importers and consumers so as to shun products
from these companies.

CREATE ENFORCEMENT DIRECTORATE
Creation of Enforcement Directorate to be involved in enforced activities such
as prosecution of manufacturers and importers of fake/counterfeit.

LEGAL UNIT
Reconstitution of the legal unit of FDB

STAFF WELFARE/WORKING ENVIRONMENT
Provision of more conducive environment and motivation-staff buses, utility
vehicles, computers, car re-furbishing loan, assistance to workers for
furthering education and skills development

ADVOCACY MEETINGS WITH LAW ENFORCEMENT ORGANIZATIONS;
POLICE SERVICE
Solicit the co-opeation and assistance in the following areas:
· Eradication of fake, adulterated and substandard drugs in the country
· Dismantling of open drug markets that have constituted a menace to
public health. Crackdown on illegal premises of drug distribution.
· Eradication of illegal manufacturing outfits of food, drugs, herbal
medicine, water and cosmetic products
· Checking the growing number of unregistered packaged water in the
market
· Checking the nefarious activities of importers substandard regulated
products
· Provide the FDB with Police men to assist in its regulatory
activities, especially in arresting and prosecuting of offenders as well as
protecting its facilities and staff.
NARCOTIC CONTROL BOARD
* Technical assistance in training of FDB’s enforcement directorate
* Collaboration in enforcement activities-Narcotics and substance of
abuse regulatory.

CEPS
· Assistance and co-operation in checking the nefarious activities of
importers of fake, adulterated and/or substandard regulated products into the
country
· Avail and/or present importation documents to FDB inspectors to enable
close examination, with a view to identifying those containing regulated
products for inspection.
· Collaborate in ensuring that stop and seizure notices issued by FDB
inspectors for violating products are honoured.

REVIEW OF FDB OPERATIONAL GUIDELINES
* Undertake public enlightment activities for herbal medicine
practitioners with more emphasis on quality and safety. Out of the
multitude of herbal medicines in circulation, a small percentage is
registered, of which most are imported. It is important the FDB educates
the National Association of Traditional and Herbal manufacturers on the role
of the Board and how best they can collaborate to increase the
acceptability of their products by the international community. The
association should see the Board as a partner in protecting public health
and also to develop their industry.
* Develop SOP for all the divisions of various directorates with special
emphasis on Registration, and Regulatory Affairs, Inspectorate, Laboratory
Services [Food & Drug] and Narcotics and Control Substances.
* Embark on planned, systematic continuous and sustained surveillance at
all entry ports and in all markets and shops as opposed to the sporadic
raids.

* Use acute toxicity as a safety parameter for herbal preparations while
reserving efficacy tests, detailed analysis and clinical trials for more
complex products such as those claimed to be HIV/AIDS, Hernia, fibroid and
cancer preparations.
* Solicit the assistance of media practitioners in ensuring that only
adverts with FDB-Advert-Permit are carried by the Print and Electronic
Media.

CONCLUSION
The achievements of the Board under the dynamic leadership of Dr. S. K Opuni are
outstanding and encouraging. This gives impetus to the dedication of the gut to
protect public health and not for only the economic benefit of its clients as in
other not-regulated countries-Russia, etc.
FDB is now a household name as her aggressive crusade against fake and
counterfeit drugs, and herbal medicine has reached the grassroots through the
series of news on its activities. The populace now scrutinize regulated products
for the manufacture and expiry dates, FDB registration number, etc. Importers
and manufacturers are now aware of the need to have their products registered
before distribution.

This new drive for registration of products is as a result of motivation arising
from considerable reduction [duration] and transparency in the registration
process. Exporters of regulated products are also taking advantage of the
conducive atmosphere now prevailing at FDB. With sustained tempo of the present
activities embarked upon by the CEO, the incidence of faking and counterfeiting
of regulated products would be reduced to the barest minimum and gradually
eradicated.
We also seek to acknowledge and observe Dr. S. K. Opuni dogged fight against
fake drugs has positively changed Pharmaceutical industries because until his
arrival “importers simply paid bribe to get their products into Ghanaian
market”. This is a reward for his supporting staff who daily risks their lives
so that the truth may be heard and powers that be are held to account.
We commend the visionary and dynamic leadership of Dr. S.K. Opuni and the
enormous support given to the FDB by President J.E.A. Mills, however we appeal
to the President to provide more funds to enable the Board beef up its
operational facilities and also intensify the campaign against fake drugs and
substandard herbal medicines especially in the rural areas. The executive and
legislative arm of government expedite action to pass the new Food & Drugs law
to provide the Board with more powers to pursue its avowed determination to
eradicate fake and counterfeit drugs.
We thank the President and the Minister for Health for reposing high confidence
in the leadership of Dr. S. Opuni against the numerous upheavals in the media
when the Board started the battle against substandard herbal medicine and
fake/counterfeit pharmaceutical products which is a bigger and more challenging
battle than the war in Afghanistan.
We commend the CEO for putting his life on the line in a bid to safeguard the
health of Ghanaians. Ayeeko
Your work requires a lot of courage, tact and professionalism. You have been
able to combine all these qualities. God spare your life so that you can
continue to provide service to humanity. Our special appeal is the same fight
should be initiated towards the food sector and the packaged water on the
market.

Written by
D. E. Amevor-D [DEAD]
P.O. Box AN 7452
Accra-North, Ghana
DENNIS EMMANUEL DORBU-AMEDZEAME
E-MAIL: DDORBU@YAHOO.COM
TEL:+233 244779860