INTERVIEW: New Philippines FDA chief brings maturity for deregulation

Less than a year into the job, Food and Drug Administration Philippines head Kenneth Hartigan-Go talks to Ian Haydock about ongoing reforms at the agency and what he is hoping the reforms will achieve.

“Finding the balance between innovation and sound regulation” is the tagline for the Food and Drug Administration Philippines. Its director general, Dr Kenneth Hartigan-Go, sees this not just as an earnest catchphrase but also as an honest attempt to encapsulate what the agency is trying to achieve.

The reality, of course, is that the route to achievement is long and strewn with challenges. It does, however, mark a clear statement of intent from a regulatory agency still formulating its long-term policies and undergoing fundamental reform, indicating that the new chief and his staff are serious about raising the quality of the services they provide, both to applicants and to safeguard the health of the country.

Indeed, attempts to rationalize regulation to ensure consistency with international best practices and to create what Dr Hartigan-Go says should be "a mature environment in which we are not afraid to deregulate" come across repeatedly during the exclusive interview that Scrip Intelligence (a Scrip Regulatory Affairs sister publication) conducted with the agency head.

"The ultimate official goal is to make the Philippines FDA an internationally recognized center of regulatory excellence," Dr Hartigan-Go states.

Dr Hartigan-Go assumed the post in August 2012 after having been asked to join the agency by Secretary of Health Dr Enrique Ona. A graduate of the University of the Philippines, he trained as a toxicologist at the Philippine General Hospital and holds a doctorate from the University of Newcastle in the UK. He also has experience in teaching and as an advisor and consultant to the US Agency for International Development, the World Health Organization and the European Union, while his stint as deputy director of the Bureau of Food and Drugs (BFAD, the FDA's predecessor) at the turn of the millennium meant he did not come cold into the regulatory arena.

The FDA Philippines operates under the Philippines department of health and has a broad remit, overseeing manufacturers, importers and retailers. It carries out inspections and audits in addition to registrations, and is responsible for approvals of medical devices, cosmetics and hazardous household products in addition to its titular products. "We cover around 75,000 establishments all told but unfortunately many others still remain unregulated," the FDA Philippines head concedes.

Given that the FDA Philippines' staff totals a modest 409 people, including around 50 responsible for approval reviews of prescription drugs within the center for drugs regulation, this is perhaps not surprising.

The FDA Philippines was created in its current form by Republic Act 9711 (otherwise known as the FDA Strengthening Act of 2009), which renamed the BFAD and gave the new administration the authority to retain its income. Among other things, the Act created a single FDA Philippines directorate with responsibility for regional operations, the aim being to improve local enforcement.

One of Dr Hartigan-Go's early initiatives was to conduct an internal quality audit of the agency's officers. "We used to use a lot of outside contractors to help conduct product evaluations, but there was no real system to ensure consistent interpretation of regulations," he said.

"So we have now initiated a program of in-house training including an 'FDA academy' to address these issues and build up internal capabilities, and are also looking to apply the 'regulatory guillotine' to review and remove redundant regulations to further improve processes," Dr Hartigan-Go explained.

While such moves are likely to be welcomed by applicants, Dr Hartigan-Go stressed that the aim is to maintain a "scientifically robust" approach while streamlining and improving efficiency where possible. The official target is to complete a review for a new drug in 180 working days, and while progress has been made, "in reality it is still taking a year in some cases, particularly for incomplete applications," he noted.

When Dr Hartigan-Go came into the top job, the FDA was facing a backlog of approval applications, some going back as far as five years. From December 2012 to January this year, it temporarily suspended applications to help clear this while giving time for internal restructuring and to draw up revised protocols. (Table 1 shows the number of approvals and applications from 2012-2012).

Table 1. Number of approvals/applications at Philippines FDA, 2010-212

	2010	2011	2012
	Approvals/applications
Innovative drugs	46/89	51/146	2/78
Branded/unbranded generics	1,527/2,457	1,078/1,993	111/2,306

Source: Philippines FDA

Dr Hartigan-Go admits that reviews can be slow at present due, in part, to limited staff numbers. However, he highlights several measures that are in progress to continue process improvements, including increased use of e-dossiers (for example based on CD-ROMs and other media) to speed up data access and tracking, and a new electronic system to facilitate fee payments. "This will do away with the current need for [paper] signatures from three of four officers, enable easier spreading of evaluations by teams rather than individuals and reduce document handling time," he said.

In fact, as part of the push for consistency and harmonization, the FDA Philippines issued an administrative order in April for the adoption of ASEAN (Association of South East Asian Nations) standards on common technical dossiers and common technical requirements for drugs, and intends to formally adopt these into its national regulations.

The FDA Philippines generally supports such regional regulatory initiatives, stating that it is clear that a "duplicitous system of technical requirements…has to stop". But it cautions that the objective of cutting red tape needs to be kept in mind and implementation done "in sync" to avoid the creation of effective trade barriers.

The other main component of the house-tidying process is clarifying almost 50 years' worth of rules and regulations to make these more explicit and easily understandable, making it easier for applicants to comply and cutting deficiencies in submissions. Past ambiguities and variations in interpretation have meant that "brokers and consultants between applicants and the FDA Philippines were widely used for consultations and to clarify procedures on an individual basis”. Dr Hartigan-Go says the FDA "hopes to reduce time spent on this."

There is also an intention to keep up with changes in technology, and part of the modernization includes planned regulations for advanced therapies such as those using stem cells.

An administrative order from the Secretary of Health has been issued on this topic, as some importation of non-approved cell therapy products and claims of unproven therapeutic benefits are going on. "A regulatory framework is in the works covering raw material sources and credentials for researchers. Labs will also need to be to GLP [Good Laboratory Practice] standards," explains Dr Hartigan-Go.

Other simple administrative steps will also be implemented. These include the standard issue of additional authenticated copies of approval certificates in order to cut future time-consuming requests for these, and the publishing of lists of approved products and new authorizations on the FDA Philippines website.

Postmarketing surveillance is another area where specific changes are planned. New drugs are currently subject to a 3,000-patient monitored release program to confirm safety and efficacy in actual use. However, Dr Hartigan-Go says that having such an inflexible system is "not a sensible or scientifically sound requirement. The number of patients is not really big enough and the industry also has to pay the costs of carrying out this monitoring, while the FDA has to have dedicated staff to monitor and approve such programs." The FDA Philippines is therefore planning to switch to a system of periodic safety update reports (PSURs) in line with the approach of many other major regulatory agencies.

It is also hoped the change will address an unusual risk in the Philippines. "One other issue we've had with pharmacovigilance is that some doctors have actually been sued for libel by manufacturers after they reported adverse drug reactions under the old system. We hope the PSURs will stop these problems," he says.

Funding issues

While the revised legislation gave the agency the right to retain its fee income and be financially sustainable (rather than relying totally on taxpayer funding), in effect the FDA Philippines still has relatively little freedom in setting its own budget and spending priorities, Dr Hartigan-Go explains. "We need to submit a five-year 'business and investment plan' for the use of retained income for approval by the central government, although we have already received operating budget approval for 2013," he says.

Political measures to confirm the move to more financial autonomy are "still in process" and might be approved next year, but there is still uncertainty over when the funding provisions of Act 9711 will be fully adopted.

The hope is that the new business plan will allow the FDA Philippines to tap into approximately a billion pesos (roughly $24 million) in retained income to complete its reorganization. This would involve finishing the integration of regional operations, expanding staff, improving IT systems and upgrading lab facilities. Such steps are becoming more critical given the Philippines' wider political goal of providing universal healthcare coverage, which the FDA says will require a robust regulatory system for the products supplied under this.

In parallel, there are plans to "correct" what is seen as a very low applicant fee structure to bring it in line with the Philippines' Asian neighbors. At present, the fee for a new drug application is just PHP20,000 (around $485), but the plan is to increase this incrementally from June 2013 to a final figure of PHP250,000.

Dr Hartigan-Go is in no doubt that users will be fully expecting his organization to improve its services and to work more effectively with industry if it is to justify a more than 10-fold increase in its fees.

And as the interface between public health and the drug industry, the FDA Philippines is cognizant of the need to move towards greater transparency and accountability in line with wider moves in the Philippines government.

From Dr Hartigan-Go’s summation, it seems clear that industry can expect a collaborative and rational partner as long as it can keep up its part of the bargain by meeting requirements and improving product stewardship. Identifying the characteristics he hopes to instill in the remodeled FDA, Dr Hartigan-Go declares: "It needs maturity for rational regulation and wisdom to deregulate."

Ian Haydock is Asia Editor of Scrip Intelligence.

This article forms part of the 2013 Scrip Asia 100, and is due to be released in June 2013. The full Scrip Asia 100 analysis includes league tables of Asia's top pharmaceutical players, interviews with the leaders of multinational companies and regulatory agencies, and insight into clinical research, market access and financial issues in the region.