House Demands More Info On FDA Overseas Operations
Executive Summary
GAO to report on foreign office closures and risk-based inspection policy amid concerns that unequal playing field remains.
House members want the Government Accountability Office to continue paying close attention to FDA's overseas efforts.
The chairmen and ranking members of the Energy and Commerce Committee and its Subcommittee on Oversight and Investigations said in a Dec. 18 letter to GAO Comptroller General Gene Dodaro that despite FDA's globalization plans "we are concerned that there is still inadequate oversight with regard to these foreign drug plants" and that "an unequal playing field" still exists between domestic and foreign drug manufacturers.
The letter asks more than a dozen questions that the committee leaders would like answered in a GAO report, including:
- How has FDA implemented its risk-based inspection system?
- How many surveillance inspections of foreign facilities has FDA conducted in the last five years?
- How does the rate of foreign facility inspections compare to domestic establishment inspections?
- What is the status of FDA staff dedicated to foreign inspections?
The 2012 FDA Safety and Innovation Act created the generic drug user fee program, which included a mandate for FDA to reach parity between domestic and foreign inspections for ANDA sponsors.
GDUFA reauthorization negotiations have included discussions of whether FDA potentially could give sponsors more information about whether inspections are required or have already been completed (Also see "GDUFA II: Inspection Information Takes Center Stage" - Pink Sheet, 23 Dec, 2015.).
But the agency also decided in its fiscal year 2016 budget request to reduce some enforcement, surveillance and other low priority field activities in order to focus on higher priority compliance issues (Also see "FDA Field Operations Would Endure Reductions Under Budget" - Pink Sheet, 9 Feb, 2015.).
The letter also asks several questions about the progress the agency's foreign offices have made since opening in recent years, including:
- How many inspections have these offices conducted?
- How have the offices improved relationships with foreign regulators and manufacturers?
- Why were some foreign offices closed?
FDA has consolidated or closed a number of foreign offices lately, including two in China and another in South Africa (see related story, (Also see "FDA Posts OCI Agent In Singapore, But Other Foreign Offices Close" - Pink Sheet, 18 Jan, 2016.)).
OIG Investigated Some Issues Already
The HHS Office of Inspector General considered some of these issues in a report that was issued in May 2015.
It found that a number of inspection requests related to generic drug facilities, most of them foreign sites, remained pending several months after their receipt.
FDA told OIG staff that a lack of resources was responsible for the preapproval inspection backlog and expected it eventually would dissipate with the addition of user fee revenue.
OIG suggested FDA use authority it received in FDASIA to request facility records in advance of an in-person visit to reduce its backlog (Also see "FDA To Pilot Remote Inspections Of Generic Facilities" - Pink Sheet, 6 May, 2015.).