From this month the US Food and Drug Administration (FDA) is sharing facility inspection data with its European counterpart and in coming years the model could expand. The FDA detailed its plans in documents to support its generic user fee proposals.
“FDA will undertake a study of foreign government regulator inspections, CGMP and bioequivalence, report findings publicly, and develop a programme to utilise foreign inspection classifications when and where appropriate”, the Agency said in a document outlining its goals for generic user fees.
The study will take place over the duration of the first generic user fee agreement, 2013 to 2017, in an attempt to boost inspection efficiency. Regulators, particularly in the US, Europe and Australia, are looking to increase sharing to cut duplicated efforts that use limited resources for little gain.
Reducing these inefficiencies is a longer-term goal at the FDA but the Agency also plans immediate action. Inspection classification results and the date of the last visit will be shared publically by the FDA on a “timely basis” and the Agency will also focus resources on high-priority tasks.
The Agency said: “[FDA] will prioritise inspections of establishments associated with abbreviated new drug applications (ANDAs) that are otherwise approvable or eligible for tentative approval except for an outstanding inspection, as well as establishments that have not been inspected previously.”
In 2008 the US Government Accountability Office (GAO) said overseas facility databases used by the FDA contain “inaccurate information”, making it difficult to select foreign establishments to inspect.
The FDA plans to develop new facility databases, or enhance existing systems, to fix the problem. At a minimum the databases will include the addresses and identifiers of generic finished dosage form and active pharmaceutical ingredient (API) production plants. Each site will be linked to ANDAs.
A separate current chemistry manufacturing and controls (CMC) records database is also planned. By developing the CMC database the Agency hopes to “aid in the efficiency of review and inspection”.
Building the databases will need industry support. “Industry will submit necessary information in electronic format to FDA using appropriate standards”, the Agency said. To support this process the FDA plans to develop electronic data submission standards.
To do the extra work outlined in the generic user fee plans the FDA will hire and train staff. In fiscal 2013 the FDA will hire and train at least 25 per cent of incremental staff, rising to 50 per cent the following year.
Adding staff will help the FDA meet its goals, one of which is achieving “parity” between inspections of domestic and overseas manufacturing facilities. “[Parity] means inspection at an equal frequency plus or minus 20 per cent with comparable depth and rigor of inspection”, the FDA said.