House Committee Asks GAO to Examine FDA’s Oversight of Foreign Facilities

January 22, 2016

A House committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities.

“We are concerned that there is still inadequate oversight with regard to these foreign drug plants, not to mention an unequal playing field compared to U.S. drug manufacturers that are subjected to more frequent and more rigorous inspections,” the letter states.

The two-page letter was signed by House Energy and Commerce Chairman Fred Upton (R-Mich.), ranking committee member Rep. Frank Pallone (D-N.J.), along with the chairman and ranking member of the oversight and investigations subcommittee.

The letter asks the GAO to evaluate the FDA’s process of developing and implementing a risk-based approach to inspecting foreign facilities, including how many risk-based inspections it has conducted at such facilities in the past five years. It also asks the GAO to compare this to domestic inspections. The letter requests that the GAO evaluate the performance of FDA offices in foreign countries, including the number of inspections conducted, interactions with foreign drug safety officials and whether the agency is having trouble staffing these facilities.

According to the letter, the request was prompted by changes to FDA policy and its legal authorities in the five years since the GAO last reviewed the agency’s handling of foreign suppliers. Additionally, the letter asks GAO to determine why the FDA has not fully implemented all of the office’s recommendations in that 2010 report, which urged it to develop performance goals and a workforce plan for overseas staff. In the report, the GAO said the FDA had made progress in increasing the number of inspections of foreign facilities — 424 in 2009 versus 324 in 2008. According to the HHS fiscal 2016 budget request, there will be an estimated 999 inspections of foreign human drug establishments and 1,856 of domestic facilities during this fiscal year.

The letter also references “decades” worth of alleged counterfeiting, adulteration, substandard manufacturing and data falsification at facilities in China and India. As an example, it cites allegations of bizarre conduct at some foreign facilities, including a media report of a plant worker at Zhejiang Hisun Pharmaceutical in China who supposedly was caught deleting records from a quality control lab during an inspection and when confronted, turned and ran. This allegation could not be independently corroborated by FDA records.

A GAO spokesman says the request will go through the office’s “standard review process” before a decision is made whether to accept the request. He adds the vetting process typically takes several weeks.

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