Is the FDA Efficient & Responsive Enough

*IMANI Petition: Is the FDA Efficient & Responsive Enough to Protect Ghanaians?*

*October 8th, 2013*

Recent events surrounding the withdrawal from the Ghanaian market of Gsunate, an antimalarial suppository targeted at infants, and the warning a few months ago of fake coartem tablets being sold on the market, have turned a strong spotlight on the issue of medicine regulation in this country.

The Gsunate and coartem incidents both highlight the human security and preventive nature of the FDA’s work: the Authority is there to make sure we are not swallowing poisons thinking we are taking medicine. This is classic law enforcement and security management work.

We can understand that the FDA in exercising this aspect of its actions will employ all the zeal necessary to protect the citizens of Ghana, just as we would expect of the police, the military, or the intelligence services.

But there are two other dimensions of the FDA’s work that require a different evaluation criteria and mindset.

The FDA has an equally important mandate to develop the pharmaceutical sector in this country to ensure that safe medicines are available to all. This includes helping build the capacity of the companies constituting that industry, and collaborating with academic and research institutions to promote the availability of skilled pharmaceutical manpower, especially in the quality assurance area.

The third dimension, linked to the second, of the FDA’s reason for existence is its service-delivery mission. It is an institution that must provide laboratory, chemical assessment, application review, and general advisory services to all players in the pharmaceutical sector seeking to dispense medicines to Ghanaians.

It is as a service delivery organisation that the FDA exerts its *most* direct impact on the well-being of players in the pharmaceutical industry, and ultimately on all Ghanaians.

Pharmaceutical marketing and manufacturing companies, for instance, interact with the FDA more in its capacity as a service delivery organisation than in its capacity as a law and regulation enforcement agency. How do they do this? Mainly through the approval and registration processes.

These are the processes related to the so-called ‘market authorisation’ system. That simply means that, to sell medicines in Ghana, the FDA needs to assess, among other things, the conditions under which the medicine was made and the physiological properties of the substance being called medicine.

When a company submits a dossier of information and/or samples to the FDA, it will be doing so in reasonable expectation of a certain level of responsiveness from the medicine regulatory agency. Especially since the vast majority of these companies are businesses, subject to market forces, interest rates, overheads, employee compensation demands, and taxation. Key management personnel of these companies cannot be hanging around the FDA’s corridors for ever waiting to be seen or heard.

Since the Gsunate matter hit the news, we have been undertaking a sentiment survey of the pharmaceutical industry to gauge the perceptions of key players about the FDA’s responsiveness, its quality of service, and general excellence of delivery.

What we have been hearing has not been too pleasant.

Of the 68 importers, distributors, marketers and manufacturers whose views were sampled, all of them felt that the FDA’s quality of service, responsiveness, and general excellence of delivery needed “substantial improvement”.

When our survey team asked them about timelines for approval or notification of non-approval/rejection, more than two-thirds of these companies indicated a waiting period of more than a year for at least one product submitted to the FDA for registration in the course of the last 5 years. It is important to note that for the most part, the FDA is not assessing novel medicines but generics that have already undergone detailed clinical trial studies elsewhere.

When we inquired whether the respondent companies usually received the right amount of information from the FDA whilst their application was pending, an incredible 95% said ‘no’.

Asked to comment on the timeframe of 2007 to 2012 (five-year horizon), several respondents complained of never receiving an ‘acknowledgement letter’ after submitting their dossier/sample.

An equally surprising number said they had great difficulty trying to find out at what stage their application was. What we found perplexing was the large number of respondents who said the FDA would often fail to disclose in a timely fashion that they had concerns with any aspect of their request for clearance until products that had been at the port for months were on the verge of expiry.

In general, a mood of despondency and resignation has enveloped clients of the FDA for many years now, and certainly for the past 5 years. The concern we have is that the FDA does not appear to see these stakeholders as ‘clients’ of theirs. There is no ‘performance pact’ binding the regulatory authority that these companies can rely on to ground their expectations of quality of service from the FDA. And this clearly has to change.

We are calling on all concerned citizens and stakeholders of the pharmaceutical sector to join us in demanding a panel of enquiry to investigate service levels at the FDA. The panel of inquiry should have representation of all key stakeholders in an environment of candour and openness. It should also have experts in quality benchmarking, systems analysis, process optimisation, customer service, and customer relationship management.

The ‘candour and openness’ bit is critical. We discovered a great degree of fear of speaking out when we interacted with those at the receiving end of the FDA’s services, with virtually no respondent available to comment on record.

There was a sense that the companies do not share a common framework with the FDA about what the regulatory process is meant to achieve, and that the vast majority of companies found the FDA’s processes and activities somewhat opaque and beyond their capacity to appreciate. This appears to have created a sense of arbitrariness and whimsicality regarding the approval process. Some companies were simply not sure that the process runs entirely by merit.

There were rampant allegations that favouritism may be a factor, and that ‘who you know’ at the FDA could expedite your processes. This is completely unacceptable. Accountability, transparency and mutual respect and courtesy should be the hallmarks of a well-run pharmaceutical system.

In fact the same zeal the FDA applies to regulatory enforcement should now be turned onto itself to revamp its service delivery standards, and it should be done for the same reason that medicines are too critical for us to leave to ‘business as usual’. The FDA is such a sensitive agency that we cannot benchmark it with other bureaucratic agencies, whose failures may be more tolerable. It must be in a class of its own.

Whilst the first goal is to get a panel of enquiry instituted, it is important that we touch on some obvious potential ‘terms of reference’ for the panel without being seen to be second-guessing what should be an objective fact-finding and standards recommendation process.

Firstly, the FDA needs to set clear service levels and abide by them. It will need to communicate these to its stakeholders as testimony to a new social contract to deliver sound service. The FDA needs to outline the benchmarks to which it wants to be held.

Secondly, the process of approving or rejecting an application or request for registration of any product regulated by the FDA needs to be completely transparent. This can be achieved through simple technology. Members of the public and stakeholders in the pharmaceutical sector need to know on a regular basis which products submitted for approval by which company will be considered at which meeting of the approval committee. Similarly, outcomes of that committee’s deliberations need to be available by the public and stakeholders simply by visiting a website or calling a hotline.

Companies who apply for various FDA services should be able to track the assessment activity from end to end, and information should flow at every stage of the exercise. This should be easy to achieve through a revamp of the system.

The FDA’s laboratory services unit should be more tightly integrated into its customer services and client relations departments to create a responsive, client-centred, focus aimed at serving pharmaceutical stakeholders with care and responsiveness.

Should we fail in our duty to encourage and goad the FDA into adopting these basic service delivery standards, and to even go beyond that in anticipating the needs of its clientele, we could wake up one day to find that the pharmaceutical industry in Ghana has been decimated through neglect. Safe medicines cannot be delivered to the masses of Ghana without a vibrant and efficient pharmaceutical industry. A regulator that is itself inefficient or one that lacks client focus in its central service delivery functions will hamstring the industry it seeks to regulate.

It is for the above and many other reasons that we shall be presenting this article in the form of a petition to the FDA, the Ministry of Health and the parliamentary committees or sub-committees on health. The expected outcome is that a panel of inquiry shall come up with a comprehensive service standards and performance pact for the FDA in order to enhance its capacity to promote the development of the Ghanaian pharmaceutical sector into a world class industry.

It should be considered as much a failure of the FDA, as it certainly is of the individual companies themselves, if the Ghanaian industry appears to be retrogressing in quality terms. It is and should ever be the FDA’s duty to ramp up its own internal capacity to lift up Ghanaian pharmaceutical companies that seek genuinely to abide by quality standards and regulations.

We look forward to a responsive reaction from the FDA, and we ask all concerned Ghanaians to join us in calling for a panel of inquiry into existing standards at the FDA and how they can be massively improved.

*Source: IMANI Center for Policy & Education*