Advance Notice, Staffing Still Harm Foreign Inspections: GAO
Preliminary findings from a new Government Accountability Office (GAO) study on FDA’s foreign inspection program acknowledge improvements but point up remaining challenges, such as staffing concerns and reliance on pre-announced inspections. GAO has been evaluating the foreign inspection program routinely for two decades and it remains on the watchdog’s “high-risk series” due to long-standing concerns about FDA’s ability to oversee the burgeoning global supply chain, GAO health care director Mary Denigan-Macauley testified at a 12/10 House Energy and Commerce oversight subcommittee hearing.
CDER director Janet Woodcock told the hearing that her Office’s recent reorganization that established an Office of Pharmaceutical Quality and an Office of Surveillance helps provides assurance that all areas of manufacturing concerns are being looked at. There have been increases in foreign inspections and Warning Letters issued, and she predicted improved manufacturing performance in India and China, the two biggest international drug manufacturing sources.
Despite seeing improvements, Woodcock said much more is needed, like hiring 20 more investigators by the end of the year and 30 next year to fill vacancies, and foreign-based office staff need additional hires as well. Staffing shortages are an ongoing problem at FDA and the booming economy does not help attract or retain talent, Woodcock said. FDA has to hire 400 employees to net just 100 due to attrition, she said. GAO’s findings noted that a recent shortage of investigators has led to a slip in foreign inspections conducted annually. In 2016, foreign inspections reached an all time high of 1,035. In 2017 and 2018, those numbers slightly dropped to 993 and 935, respectively.
Woodcock said that what really is important is transforming the agency’s inspection site-selection model into a “true quantitative predictive model that will require data instead of .pdf files, which is what we get now.” She also said industry needs more stimulation to move to advanced manufacturing techniques, and there needs to be “standardization and internationalization of quality standards” to improve overall quality.
Additionally, Woodcock said that recognizing quality maturity as an important factor in manufacturers’ production would help ensure better products coming from overseas. Quality maturity is outlined in FDA’s recent drug shortages report (see story), and it focuses on continuous improvement and early detection of supply chain issues.
Many of the subcommittee members were concerned that FDA’s provision of advance notice to foreign firms before an inspection allows them to clean things up and hide problems. Woodcock told the hearing that unannounced inspections are still conducted abroad in “for cause” situations. She said announced inspections are more efficient when sending domestically located investigators overseas to conduct site audits. The agency wants to make sure that the proper personnel are at the site and that production is underway before assigning resources to such surveillance activities. Subcommittee members were also concerned that FDA investigators rely on company-provided translators during inspections. Woodcock told the hearing that the agency has been given funding to begin offering contracts for independent translators.
Rep. Raul Ruiz (D-CA) questioned whether data integrity and fraud concerns with overseas firms could be reduced with more unannounced inspections after Denigan-Macauley said the GAO has heard from FDA inspectors in China and India that after giving firms 30 minutes advance notice, employees were caught destroying records. Woodcock said the agency has seen similar problems with domestic inspections. She noted that investigators can easily detect fraud in announced inspections by looking at computer data and records. Denigan-Macauley also said that some investigators complained about their inspection findings being overridden and inspections reclassified by supervisors to show passing results. This will be looked at further through ongoing GAO assessments, she said.