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Highlights

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees the safety and effectiveness of human drugs marketed in the United States, including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection, (2) the frequency of foreign inspections, and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. GAO analyzed information from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration To address weaknesses in FDA's oversight of foreign establishments manufacturing drugs for the U.S. market, the Commissioner of FDA should enforce the requirement that establishments manufacturing drugs for the U.S. market update their registration annually.
Closed - Implemented
FDA has been taking steps in response to this recommendation for several years and its implementation is now complete. These steps included two phases of action and enforcement. The first phase began in the latter half of 2011 when FDA started a cleanup initiative of its registration data to eliminate inactive establishments from the database and bring active establishments into compliance by getting them to update their records. According to FDA, it sent letters to foreign establishments reminding them of their annual obligation to renew their registration and information on how to do so. The agency specifically contacted drug establishments that had let their registration expire or that had failed to notify FDA that they no longer performed drug operations at the facility. It ultimately deactivated the registration of 1,623 foreign establishments that failed to re-register or otherwise respond to FDA. The second phase of enforcement, which began in fiscal year 2012, involved identifying and contacting establishments that had let their registrations expire, but were still actively engaged in drug manufacturing. These establishments were sent official warning letters with a charge of misbranding. These letters indicated that the agency had identified violations that may lead it to initiate enforcement action if not promptly and adequately corrected, based on the distribution of a drug produced at a facility that is not duly registered. FDA has taken the additional step of issuing import alerts aimed at stopping the importation of drugs from establishments that fail to properly register. These import alerts subject the establishments to detention of their products without physical examination at the U.S. border.
Food and Drug Administration To address weaknesses in FDA's oversight of foreign establishments manufacturing drugs for the U.S. market, the Commissioner of FDA should establish mechanisms for verifying information provided by the establishment at the time of registration.
Closed - Implemented
FDA has now implemented this recommendation. After GAO's report was issued, FDA requested that establishments submit a unique identification number--a Dun and Bradstreet Data Universal Numbering System (D-U-N-S) Number. The use of this unique identifier and the associated data had the potential to enhance FDA's ability to verify information about foreign establishments, including whether they have gone out of business or relocated, as well as help the agency avoid duplications and errors in its data systems. However, FDA could not require it the D-U-N-S Number be used and so an establishment's use of it was voluntary. Several years later, in July 2012, The Food and Drug Administration Safety and Innovation Act mandated that the Secretary of HHS designate a unique facility identifier and require its use in establishment registration. The Secretary designated the D-U-N-S Number as the identifier to be used. FDA issued draft guidance in September 2013 that, when finalized, will implement this provision.
Food and Drug Administration To address weaknesses in FDA's oversight of foreign establishments manufacturing drugs for the U.S. market, the Commissioner of FDA should ensure that information on the classification of inspections with serious deficiencies is accurate in all FDA databases.
Closed - Implemented
In 2011, FDA reported that it would be replacing its Office of Compliance's Foreign Inspections Tracking System (OCFITS) database with a new database--the compliance management system (CMS). In 2012, FDA reported that the new CMS module became operational in October 2011. CMS is linked directly to FDA's Field Accomplishments and Compliance Tracking System (FACTS), thereby, eliminating any possible discrepancy between the two systems. The implementation of CMS allows FDA to generate consistent and reliable information about foreign inspections. When a firm's information is updated in FACTS, the same information is updated in CMS. This allows FDA to generate a variety of reports, such as inspections by countries inspected and the inspection outcome and also enables FDA to generate timeline metrics. FDA is considering adding more functionality to CMS such as identifying inspection reports not yet received or reviewed by agency officials. FDA's new reliance on CMS should enhance its oversight of foreign drug establishments and improved the overall management of its foreign drug inspection program.
Food and Drug Administration To address weaknesses in FDA's oversight of foreign establishments manufacturing drugs for the U.S. market, the Commissioner of FDA should conduct more inspections to ensure that foreign establishments manufacturing drugs currently marketed in the United States are inspected at a frequency comparable to domestic establishments with similar characteristics.
Closed - Implemented
FDA has steadily increased the number of foreign drug inspections conducted in recent years. According to FDA officials, the agency leveraged multiple staff resources to enable it to increase the number of these inspections. For example, the agency expanded the number of investigators in the dedicated foreign drug cadre, which was established in 2009. Additionally, the Generic Drug User Fee Amendments Act of 2012 provided FDA the resources to hire 80 investigators focused on inspecting generic drug manufacturers. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspections. In addition to conducting more inspections, FDA is taking a risk-based approach in selecting establishments to inspect. FDA has now fully implemented a risk-based site selection model, and for the first time, generated a combined list of foreign and domestic establishments for use with the fiscal year 2016 risk-based sited selection model. This model allows the agency to identify those establishments (both domestic and foreign) that, based on the characteristics of the drugs being manufactured, pose the greatest potential public health risk should they experience a manufacturing defect. In 2015, the agency formalized its process for selecting establishments for inspection according to an establishment's known safety risks, based on certain risk factors specified by Food and Drug Administration Safety and Innovation Act. These risk factors include an establishment's compliance history and the inherent product risk.
Food and Drug Administration To address weaknesses in FDA's oversight of foreign establishments manufacturing drugs for the U.S. market, the Commissioner of FDA should conduct timely inspections of foreign establishments that have received warning letters to determine continued compliance.
Closed - Implemented
In August 2009, FDA announced it planned to take several steps to prioritize its enforcement efforts, including reinspections of establishments that received warning letters. Over time, FDA has worked to strengthen its oversight of foreign establishments. Among other things, it has instituted an evaluation--that is performed at least annually--of the need for reinspection of all firms, including those that received warning letters. In July 2017, FDA provided data that showed that most establishments that received warning letters in recent years had either been reinspected by FDA or their products were not allowed into the U.S. supply chain.

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