GAO Testifies on FDA Initiatives to Improve Foreign Drug Inspection Program Weaknesses
In April 2008, the Government Accountability Office testified before a House Subcommittee1 that recent Food and Drug Administration initiatives could strengthen its foreign drug inspection program, but do not fully address the weaknesses that GAO previously identified in 2007 testimony.
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(The timing of this testimony is due in large part to heightened concerns regarding FDA's foreign drug inspection program, after contaminated doses of a common blood thinner were found to be manufactured at a Chinese establishment.)
Weaknesses Identified by GAO in Late 2007
In November 2007, GAO issued testimony presenting preliminary findings that identified the following weaknesses in FDA's foreign drug inspection program:
(1) FDA's database does not provide an accurate count of foreign establishments subject to inspection;
(2) Gaps in information weaken FDA's processes for prioritizing the inspection of foreign establishments that pose the greatest risk to public health;
(3) FDA inspected relatively few foreign establishments each year; and
(4) FDA faced certain logistical and staffing challenges unique to conducting foreign inspections.
GAO Evaluates FDA's Efforts to Improve These Weaknesses
In its April 2008 testimony, GAO examines FDA's initiatives to improve the weaknesses in its foreign drug inspection program and identifies the ways in which FDA has not fully addressed these weaknesses, as follows:
Inaccurate count of foreign establishments. GAO states that FDA plans to implement electronic registration for foreign establishments, which may reduce inaccuracies in its database. However, it will not prevent foreign establishments that do not manufacture drugs for the U.S. market from registering with FDA (registration in some markets may appear to convey approval).
To reduce duplication in its import database, FDA is also pursuing the creation of a government-wide unique establishment identifier, as part of the Shared Establishment Data Service (SEDS). Rather than relying on the creation and entry of an identifier at the time of import, SEDS would provide a unique establishment identifier and a centralized service to provide commercially verified information about establishments. The standard identifier would be submitted as part of import entry data where required by FDA or other government agencies.
The implementation of SEDS is dependent on action from multiple federal agencies, including the integration of the concept into a U.S. Customs and Border Protection import and export system currently under development and scheduled for implementation in 2010. In addition, once implemented by CBP, participating federal agencies would be responsible for bearing the cost of integrating SEDS with their own operations and systems. FDA officials are not aware of a specific timeline for the implementation of SEDS.
Information gaps from foreign regulatory bodies. GAO testifies that while FDA recently expressed interest in obtaining useful information from foreign regulatory bodies that could help it prioritize foreign establishments for inspections, it has faced difficulties fully utilizing these arrangements in the past. For example, FDA had difficulties in determining whether the scope of other countries' inspection reports met its needs and these reports were not always readily available in English.
Too few foreign inspections. GAO states that FDA made progress in inspecting more foreign establishments in fiscal year 2007, but it still inspects far fewer of them than domestic establishments. FDA dedicated about $10 million to foreign drug inspections in FY 2007 and plans to dedicate about $11 million to such inspections in FY 2008.
FDA staffing challenges. FDA is pursuing initiatives that could address some of the challenges identified as being unique to foreign inspections, such as volunteer inspection staff and lack of translators. FDA has proposed establishing a dedicated cadre of staff to conduct foreign inspections, but the timeframe associated with this initiative is unclear.
FDA plans to open an office in China and is considering establishing offices in other countries, but the impact that this will have on the foreign drug inspection program is unknown. (See ITT's Online Archives or 03/24/08 news, 08032499 2, for BP summary of the State Department's approval of eight new U.S. direct-hire full-time permanent positions for the FDA in China.)
1The House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations
(See ITT's Online Archives or 01/11/08 news, 08011199 13, for BP summary of GAO's November 2007 testimony.)
GAO testimony (GAO-08-701T, dated 04/22/08) available at http://www.gao.gov/new.items/d08701t.pdf