Senator Chuck Grassley (R-IA), Chairman of the US Senate Finance Committee, has submitted a letter to US Department of Health and Human Services’ (HHS) Secretary Alex Azar and the US Food and Drug Administration’s (FDA) Acting Commissioner Norman Sharpless over concerns with the FDA’s foreign-drug inspection program, including the need to make unannounced FDA inspections of foreign drug-manufacturing facilities.

Senator Grassley submitted his letter in response to the HHS’ Safe Importation Action Plan, which was released last month (July 2019) and which outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets. Senator Grassley also raised concerns in a letter he earlier submitted to the FDA in June 2019 regarding the FDA’s inspection program for foreign-drug manufacturing facilities. In that June letter, citing a report by the Government Accountability Office, he noted that “…80% of Active Pharmaceutical Ingredients (API) are produced abroad, the majority in China and India; however, the FDA only inspected one in five registered human drug manufacturing facilities abroad last year.”

In his current letter to the HHS and the FDA on August 6, 2019, Senator Grassley raised concerns that FDA inspections of foreign drug-manufacturing facilities are announced and called for the Safe Importation Action Plan to require more inspections and unannounced inspections of foreign drug-manufacturing facilities. “I have learned that the FDA does not track in its databases whether a foreign inspection was subject to an announced or unannounced visit. Further, I have learned that the FDA generally does not perform unannounced visits of drug manufacturing facilities in foreign countries but does perform unannounced visits at facilities based in the United States. Should the Action Plan [the Safe Importation Action Plan] be put into effect, the [A]dministration must require more foreign inspections generally and unannounced inspections specifically, particularly compared to previous administrations.”

One pathway for implementing the Safe Importation Action Plan is through a notice of proposed rulemaking (NPRM). Current federal law allows for drug importation as long as certain conditions are met, including drug quality, record-keeping, testing, and protections against. The Safe Importation Action Plan notes the NPRM would list those requirements and invite proposals as to how those conditions would be met by a demonstration project. In his August letter to the HHS and the FDA, Sen. Grassley asked that such demonstration projects by the Administration include unannounced inspections of foreign manufacturing facilities to determine whether they meet the required active pharmaceutical ingredient and drug quality and safety standards for sufficient record-keeping, testing, and protection against counterfeiting.

In his August letter, he pointed to an FDA pilot program, created in 2013, in India that eliminated advanced notice and instead used short notice or unannounced visits. The pilot program also arranged for FDA inspectors’ travel to be arranged through the US embassies instead of through FDA offices or manufacturer-arranged travel plans to provide more secrecy in the lead-up to inspections. He noted in his letter, “[a]ccording to reports, the new inspection regime ‘exposed widespread malfeasance’ that had otherwise been hidden because of the advanced warning system. Among the findings, the inspections found bird infestations, missing samples, and fake laboratories… Under the pilot program, the FDA issued a 60% increase in ‘Official Action Indicated’ findings. In 2015, the pilot program was shut down without explanation.”

Source: United States Senate Committee on Finance, US Department of Health and Human Services