Risk Through Product Life-Cycle September 26, 2018

Speech | In Person

Remarks by the Melinda K. Plaisier, U.S. FDA Associate Commissioner for Regulatory Affairs
Pharmaceutical Inspection Co-operation Scheme (PIC/S) Seminar

It is my privilege to welcome all of you to the PIC/S Training Seminar. I want to recognize PIC/S Chairman Boon Meow Hoe, the PIC/S Executive Bureau, PIC/S Secretariat, and all of you for attending the first Annual Training Seminar held in the United States. As host, and on behalf of U.S. FDA’s Commissioner of Food and Drugs, Dr. Scott Gottlieb, and the entire FDA delegation, I want to welcome you to the United States and to Chicago.

There are just over 200 inspectors from 46 countries registered for this seminar, which represents more than 88% of PIC/S members. Such a strong turnout reflects the profound effects that globalization is having on the regulatory landscape and the importance and value of us as regulators working together to leverage our knowledge, skills, and abilities.

It is also a reflection of how PIC/S has evolved from 1970 and its initial beginnings of just 10 members to a broader scheme of 52 authorities. It speaks also to our shared commitment to work together to lead the international development, implementation, and maintenance of harmonized Good Manufacturing Practice standards and quality systems of inspectorates in the field of medicinal products.

Complex global supply chains and increasing numbers and volumes of products sourced from around the globe have been a driver for our own evolution and modernization at U.S. FDA. As we approach the 10-year anniversary this year of establishing our global offices in China, India, Latin America, and Europe, this evolving modernization has become integral to the way we now work, incorporating a global component into all our programs across FDA. We have worked hard to forge collaborations with our international regulatory counterparts, and as the forces of globalization continue to increase, I know we all recognize the importance of working together.

The inspections you do are not just for your own country, and you must realize that the inspections you conduct may be used by other authorities to make decisions.

And, as the head of U.S. FDA’s inspectorate, it is my view, that you — the inspectors, we say investigators — are the foundation, the backbone, the front lines, or whatever other analogy you wish to use, but you carry one of THE most important responsibilities for public health through your inspectional work.

This seminar’s topic of Risk through the Product Life-Cycle addresses the fact that we as regulators are continually assessing risk: from the risk that helps determine which sites to inspect to the risk of what critical aspects to inspect.

These responsibilities, along with the growing complexity and emerging technologies of drug products, present regulatory challenges, but organizations such as PIC/S are instrumental in ensuring that inspectors from across the world are assessing GMPs in a harmonized way.

The reality is that we all have limited inspectional resources. As global citizens and recognizing the global nature of public health, we must find ways to share information from inspectional outcomes.

Over the past 25 years, globalization of drug manufacturing has prompted the U.S. FDA to also evolve. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s, adding new complexities to our supply chain. This required us to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and to make sure consumers and patients continued to receive safe and effective drug products. Helping assure the quality and safety of globally produced products requires a variety of efforts at different times throughout the lifecycle in drug manufacturing and distribution.

Our respective inspections and surveillance of manufacturing facilities are an integral part of this oversight. We need to make sure that our inspections are prioritized commensurate with potential risks to patients, and that we’re using our resources efficiently.

You are going to hear later today about how U.S. FDA prioritizes inspections of sites regardless of their location. For manufacturing facilities in other countries, inspections may be conducted by staff in foreign offices, those on temporary duty assignments, or staff that travel internationally to conduct the inspection.

In addition, to maximize resources and efficiency, we’ve pursued opportunities to collaborate with other countries. With our announcement last year regarding the Mutual Recognition Agreement with the European Union, we’ve ensured that we can recognize the drug inspections conducted by foreign regulatory authorities that meet U.S. requirements. In doing so, we’re able to dedicate more of our investigators’ time to those sites that pose the greatest risk.

The U.S. FDA’s inspections program is a large-scale endeavor, we cover all programs — human and animal food, biologics products, bioresearch monitoring, medical devices and radiological health, import operations — as well as pharmaceuticals. For our pharmaceutical inspectorate alone, as of Fiscal Year 2017, there were about 5,063 human pharmaceutical sites worldwide subject to routine surveillance inspection. Of these, 3,025 were foreign-based. Last year, FDA conducted 1,758 domestic drug inspections and 1,279 foreign drug inspections. To accomplish this critical work, we need to maximize our inspectional resources to ensure that they are allocated in the most efficient and appropriate manner to protect patient health.

We have also made efforts to ensure our resources are effectively deployed to address inspection demands. Last year, for example, we modernized the structure of our field organization by exclusively specializing all of our operational staff into single program areas. We now have a dedicated pharmaceutical inspectorate, a device inspectorate, human and animal food inspectorate, biologics inspectorate, bioresearch monitoring inspectorate, and import operations.

Previously, while we were highly specialized, we were not exclusively specialized, and we had organized our field activities and resources based on domestic geographic regions. Our new specialized structure, allows us to better align within FDA with the program centers, expand the expertise of our inspectors and operational managers, and more strategically deploy those resources.

Efforts, including cooperation and harmonization, with other foreign regulators is critical to ensuring that the drug supply produced meets GMPS. PIC/S is uniquely positioned to lead this harmonization effort. We all must continue the efforts and support of PIC/S to ensure inspectors are well trained and are able to keep up with a standardized curriculum and emerging technologies. Having the same training across multiple regulatory agencies makes it easier for manufacturers to ensure compliance with quality standards. This approach also reduces the burden from having to implement different sets of requirements.

This is also an important role of our foreign offices — to establish relationships with foreign regulators and to build our intelligence regarding these markets so we can target higher-risk firms.

We’re also committed to fostering more advanced training that encompasses advanced manufacturing technologies and that is implemented in a way that leads to more innovative, consistent, and dependable manufacturing of drug and biological products. These technologies have the potential to help establish a more reliable supply of drug and biological products by reducing manufacturing failures that can cause supply disruptions and drug shortages.

As inspectors, you have an enormous job inspecting facilities and ensuring the integrity and GMP compliance of human and veterinary drugs, vaccines, and other biological products for human use. And, as I previously stated, it is my view that you have one of THE most important responsibilities in protecting public health.

As leaders, it is our responsibility to ensure you have the training and tools you need to effectively carry out your important duties.

I’m honored to be with you today, and on behalf of FDA, we are so privileged to be your host.

Thank you, very much, for the work you all do every day. As public health colleagues, we should continue to work together to ensure that PIC/S facilitates meaningful regulator-to-regulator collaborations that further our mission on behalf of the consumers, patients, and communities we all serve.

All the best for a successful seminar.