FDA seeks more specialisation in agency structure
pharmafile | February 18, 2014 | News story | Manufacturing and Production | FDA, GMP, ORA, fdasia, hamburg, opq, ufi
An internal review of the US Food and Drug Administration has concluded that the agency needs to restructure its compliance operations around six specialised areas.
A memo sent out by FDA Commissioner Margaret Hamburg earlier this month indicates that the increasing diversity and complexity of manufacturing operations in the sectors it covers is placing “ever greater demands on the agency”.
“Our responsibilities are changing rapidly, forcing us to work in fundamentally new ways and to be as technologically up-to-date as possible,” she wrote, noting that the Office of Regulatory Affairs (ORA) will continue to play a key, overarching role alongside the various FDA centres but will be aligned more closely with them.
At the heart of the structuring – which Hamburg admits will take some time – is a reorganisation of regulation and compliance and enforcement teams around the various commodities it oversees, including drugs, medical devices, biologics, food and tobacco.
The memo indicates that a higher level of specialisation is needed not just for the inspection and laboratory teams, but also the compliance officers who manage the results of investigations, with the aim that a ‘cadre’ of officers would be created with a similar level of experience to specialised investigators.
For example, “some medical devices are so complex that we may need sub-specialists trained in just a segment of that industry in order to carry out effective oversight of a manufacturer,” she noted.
The ORA and centres will also be instrumental in developing the training needed to pursue the specialisation objectives, and there will be a general shift towards vertically-integrated units with strong leadership and fewer layers of case review to “better enable FDA to take timely and appropriate action, avoid duplication, improve efficiency and enhance accountability”.
Other areas highlighted for change in the memo are the FDA’s laboratory services – with a new senior scientist providing leadership and collaboration between agency units – and new processes for handling imported commodities.
At the heart of all the changes at the FDA is a shift towards great use of quality metrics and risk-based monitoring, and Hamburg illustrated this by asking senior FDA personnel to develop work plans based on “risk factors, public health outcomes, past inspectional history and operational experience.”
FDASIA effect
In part as a result of the requirements of the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012 – which is widely regarded as the most significant update to pharma manufacturing legislation since the Good Manufacturing Practice (GMP) requirements were introduced in the 1930s – and updated in the 1970s – the FDA has already started shaking up its oversight of the drug sector.
FDASIA revises the definition of GMP and also gives the FDA new authority to oversee the global supply chain to protect patients in the US, with a number of new elements that will be promulgated via guidance documents and rules.
New features include detention powers for imported drugs, risk- rather than frequency-based inspections for facilities, unique facility identifiers (UFIs) so plants involved in making medicines or raw materials are clearly recorded, greater freedom to exchange information with other regulators, and stricter penalties for counterfeiting and adulteration of medicines and ingredients.
Last year, the agency kicked-off the structural changes needed to support these initiatives with the creation of a dedicated Office of Pharmaceutical Quality (OPQ) which will be headed by Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research (CDER). It is expected that the new office will subsume many of the functions currently handled by the Office of Pharmaceutical Science (OPS), which may be dissolved when the OPQ comes into being.
OPQ will have eight subsidiary offices, covering: policy; operations; biotechnology products; new drug products; lifecycle drug products; process and facilities; surveillance; and testing and research.
Meanwhile, in tandem with the structural changes the FDA is in the process of revising its GMP regulations to make sure they are in line with FDASIA. It is already consulting with industry on ways to harvest quality metrics data that may provide a signal of non-compliance, rather than relying only on the findings of its inspection teams, and provide ‘risk-ranking’ for both facilities and products.
What is clear is Hamburg wants the FDA to move ahead with its reorganisation plan swiftly. She would like to have action plans from all key centres and offices by the start of October with a view to start implementing in the next fiscal year.
Phil Taylor
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