Inspections
This article was originally published in SRA
Executive Summary
US FDA misses time requirements for inspections
US FDA misses time requirements for inspections
The US Food and Drug Administration has failed to meet its statutory requirement of inspecting every two years certain domestic establishments that make medical devices, and it faces challenges inspecting foreign establishments.
These were the conclusions of a study1from the US Government Accountability Office, which was presented on 29 January to a subcommittee of the House Committee on Energy and Commerce.
The findings, delivered in a testimony by Marcia Crosse, director of health care at the GAO, mark another blow for the FDA, which was recently accused by the FDA Science Board of suffering from serious scientific deficiencies and of being unable to meet current or emerging regulatory responsibilities2. The GAO results, said Dr Crosse, are consistent with those of the FDA Science Board, regarding the FDA's ability to fulfil its regulatory responsibilities. “Our findings also support the Science Board's conclusion that the agency's work is jeopardised by information technology and human resource challenges.”
The study estimated that inspections of domestic establishments that manufacture Class III (high-risk) medical devices take place only once every three years and inspections of Class II (medium-risk) device manufacturers occur every five years.
Foreign establishments
There is no comparable time requirement for inspecting foreign establishments, but the FDA is responsible for ensuring they meet the same standards required of domestic establishments. However, foreign medical device establishments are inspected much less frequently than US establishments; about every six years for high-risk devices, or every 27 years for medium-risk devices. In the ten countries where over two thirds of inspections were performed between fiscal years 2002 and 2007, the lowest rate of inspections was in China, which has nearly 700 establishments registered, but where only 64 inspections were carried out.
Dr Crosse also talked of failings with regard to the two databases that provide the FDA with information about foreign medical establishments. DRLS and OASIS both contain inaccuracies that create very different estimates of the number of foreign medical device establishments subject to inspection, she said. As of September 2007, the DRLS database reported 5,616 domestic and 4,983 foreign establishments were registered with the FDA to produce Class II or Class III medical devices for the US market. On the other hand, the OASIS database in fiscal year 2007 reported as many as 22,008 foreign establishments manufacturing Class II devices and 3,575 foreign establishments producing Class III devices. It was noted that although comparing information from these two databases could help the FDA determine the number of foreign establishments marketing medical devices in the US, these systems cannot exchange information and any comparisons must be done manually. Dr Crosse said, however, that efforts are underway that could improve the databases.
The study, in addition, showed that inspection of foreign device establishments poses “unique” challenges to the FDA in terms of human resources and logistics. For example, the FDA depends on staff to volunteer for inspections, provides no independent translators and inspectors have difficulty altering their travel itinerary if problems are uncovered that might warrant further review.
The subcommittee also heard that use of the FDA's two accredited third-party inspection programmes to supplement the agency's inspection resources has failed to meet expectations. The Accredited Persons Inspection Program, set up in 2004, and the Pilot Multi-purpose Audit Program, established in 2006, are designed to allow for a single inspection that can meet the requirements of the FDA and of other countries, allowing manufacturers to reduce the number of inspections they must undergo. However, Dr Crosse reported that as of January 2008, only seven inspections under the programmes had taken place.
Industry comment
The FDA needs to undertake a concerted review of its many activities to make sure it is focusing its time and resources on those areas that are likely to have the most significant impact in improving patient care, said Stephen Ubl, president and chief executive of US device industry association AdvaMed.
On the other hand, Mr Ubl suggested that the FDA should determine which of its activities have little or no impact on its mission and could be scaled back without adversely affecting public health and safety. “The FDA should promote improvements to programs, such as those that were included in the FDA Amendments Act of 2007,” Mr Ubl said, “that rely on FDA trained and accredited outside third parties to perform specific agency functions. This is a way for FDA to further concentrate its expertise on areas that have the greatest benefit to patients without any way diminishing the agency's ability to inspect any facility at any time for any reason.”
AdvaMed is a member of the Alliance for a Stronger FDA, which is committed to working with the FDA and Congress to ensure that the agency has the resources it needs to meet its public health mandate.
FDA response
In response to the GAO's criticisms, the FDA said that the frequency of its manufacturing inspections varies depending on the level of risk that a medical device poses, and therefore manufacturers of low- and medium-risk devices are subject to fewer inspections than high-risk device manufacturers3.
A spokesperson for the FDA's Center for Devices and Radiological Health said this risk-based approach to inspections recognises and takes into account the wide variety of medical devices regulated by the FDA, and allows the FDA to focus its resources on manufacturers that have the greatest importance to patients and healthcare professionals. For example, the agency will inspect a manufacturer of a vital, life-sustaining device far more often and more thoroughly than a manufacturer of a lower-risk device.
Additionally, the CDRH said it hoped that streamlining changes made to the FDA's third-party inspection programme by the FDA Amendments Act 2007 will encourage companies to hire accredited third parties for their inspections, freeing up the FDA staff for other inspections.
References
1. GAO report: Challenges for FDA in Conducting Manufacturer Inspections, 29 January 2008, http://gao.gov/new.items/d08428t.pdf
2. The Regulatory Affairs Journal - Devices, 2008, 16(1), 9-12
3. Personal communication, CDRH, FDA, 31 January 2008