GAO Urges More Oversight of Foreign Drug Supply

By Mike Rozembajgier

The Government Accountability Office (GAO) released a report last month condemning the FDA’s efforts to track and regulate overseas pharmaceutical manufacturing.  The GAO report emphasized that the FDA plays a more important role than ever before in guaranteeing the safety of our pharmaceutical supplies, which the GAO suggests are vulnerable to contamination from toxic or unchecked additives at foreign manufacturing plants. With proper FDA oversight, the risk of contamination and recalls can be controlled with recall prevention, proactive recall planning, and effective recall management.

According to the GAO, as a result of an increasingly globalized and interconnected pharmaceutical market, “there are concerns that the complexity of the drug manufacturing supply chain and the volume of imported drugs has created regulatory challenges for the FDA.”

The GAO notes that, in 2007, the FDA only inspected six percent of the foreign manufacturing facilities under its supervision, despite reports that 80 percent of pharmaceuticals used in the U.S. are manufactured abroad. At that rate, the GAO suggests, “it would take the FDA about 13 years to inspect all such establishments.”  Since 2007, the FDA has increased its percentage of establishments inspected, but the agency still admits that it is “far from achieving foreign drug inspection rates comparable to domestic inspection rates.”

With counterfeit drug sales, theft, and black markets for pharmaceuticals on the increase, more oversight is vital, and manufacturers can expect an increased number of inspections at foreign facilities, especially those with a past history of proven or suspected violations. The GAO also advised that the FDA be placed on a “high risk watch-list of organizations until it more effectively uses its enforceable authority to make drugs safe for market,” reports Angie Drakulich of PharmaTech.

In a hearing on Capitol Hill following the report’s release, senators voiced their concerns about the FDA’s competence in this area. Senator Barbara Mikulski (D-Md.) characterized overseas drug supply regulation as a national security issue, saying “the American people [need to] know that if they take a prescription drug, it will be okay.” Meanwhile, Senator Michael Bennett (D.-Colo.) urged fellow senators to come together in a bipartisan effort to provide the FDA with the resources necessary to address the GAO recommendations.

Pharmaceutical companies with manufacturing arms abroad should take note of all the attention that the GAO report has generated. Sen. Mikulski’s characterization of drug manufacturing regulation as a “national security” issue underscores the seriousness with which Congress is taking the GAO’s recommendations, even though in the current political climate increases in funding and authority for any federal regulatory agency seem unlikely.

In order to ensure product safety and avoid costly and damaging product recalls,  foreign drug supply manufacturers and U.S. pharmaceutical companies with plants abroad should make sure that they are following current FDA regulations, even as the agency reevaluates its oversight authority based on the GAO recommendations.

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