The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is calling for private-sector assistance in the development of new regulatory tools that the agency hopes will allow it to evaluate drug manufacturing facilities' risk factors in real time, allowing it to better set priorities for inspection purposes and evaluate data more fully.
CDER is in charge of regulating the pharmaceutical industry for FDA, and its oversight includes all chemical drugs, some biological products and the manufacturing facilities that make, finish and provide analysis for both.
Two CDER divisions are responsible for performing facility and site inspections: the Office of Scientific Investigations (OSI) and Office of Manufacturing and Product Quality (OMPQ). Those inspections are coordinated by the Office of Regulatory Affairs (ORA), which also conducts many inspections on its own.
The many types of facilities inspected include clinical investigation sites, institutional review boards, bioequivalence sites and manufacturing facilities. The problem, from FDA's perspective, is that the resources available for it to inspect these facilities-which exist by the tens of thousands around the globe-far exceed its operational resources, even when industry-paid user fees are taken into account.
Accordingly, the agency has frequently said that it takes a risk-based approach toward inspections, going after those facilities that have the potential to most seriously impact public health or that are most likely to have deficiencies. Historically, determining which facilities to inspect has been something closer to an art than a science. Now, though, FDA is asking for help to make that process much more automated.
New Risk Modeling
In a Request for Information (RFI) posted on FDA's federal contracting website on 18 April 2013, FDA said it is looking for (but is not yet committed to purchasing) third-party support to develop new regulatory tools intended to enhance its inspectional capabilities.
"The purpose of this task is for the Contractor to determine the best commercial off-the-shelf product that can be configured, developed, implemented, and deployed to meet the requirements [of FDA's inspection divisions]," the agency wrote.
Any software would need to support real-time evaluation, priority, reporting, information exchange, interoperability between systems, data analysis and predictive modeling, and "fact-based management to drive decisions and actions," FDA explained. Those capabilities would in turn allow FDA to "select and import quality risk indicators from various internal and external sources … for risk evaluation," the agency added. Those sources are set to include field alerts, recalls and drug quality reports.
Among the higher-level goals of the project is the establishment of a set of best-practice risk models, tools and processes for the following types of inspections:
- Good Clinical Practice (GCP)
- Bioequivalence (BE)
- Good Laboratory Practice (GLP)
- Institutional Review Boards (IRB)
- Radiological Drug Review Committees (RDRC)
- Risk Evaluation and Mitigation Strategies (REMS)
- Post-Marketing Adverse Drug Experiences (PADE)
- Post-Marketing Requirements (PMRs)
- Good Manufacturing Practice (GMP)
FDA said it was looking at an 18-month time frame for project completion once (or if) it gets funded. Companies wishing to participate in the project have until 26 April 2013 to respond.