With Drug Imports Looming, Questions Raised About FDA Foreign Inspection Program

In a letter to HHS Secretary Alex Azar and FDA Acting Commissioner Norman Sharpless, MD, last week, Sen. Chuck Grassley, R-Iowa, asked the FDA to perform more unannounced inspections of foreign drug manufacturing facilities.

Grassley first wrote to the FDA about the issue at the end of June, but now says he has learned that the FDA does not track in its databases whether a foreign inspection was subject to an announced or unannounced visit.

He is also concerned that typically, the FDA does not perform unannounced visits of drug manufacturing facilities in foreign countries.

The concern takes on new urgency since last month, when HHS announced its Safe Importation Action Plan, a document outlining 2 potential pathways to allow the importation of some drugs that were intended for foreign markets.

Grassley said that while 80% of active ingredients used in pharmaceuticals are made abroad (mostly in China and India), the FDA inspected 1 in 5 registered human drug manufacturing sites in other countries last year.

“I strongly encourage the administration’s demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine whether they meet the required Active Pharmaceutical Ingredients and drug quality and safety standards to include sufficient record-keeping, testing and protections against counterfeiting,” he wrote.

This letter comes after a previous letter on the topic sent to Azar and Sharpless in June, where he sought information on the quality controls for prescription drugs and their components made in foreign countries, and also asked what the FDA is doing to uphold safety standards in the United States, China, and India through inspections.

The concern is bipartisan: In a related issue, in June the House Energy and Commerce Chairman Frank Pallone, Jr., D-New Jersey, asked the FDA for updated information on the agency’s inspections of imported cosmetic products. Pallone said he was alarmed that the agency has not conducted any foreign cosmetic inspections in fiscal year (FY) 2019 and does not intend to conduct any inspections in FY 2020.

In 2017, the General Accounting Office issued a report about the FDA’s inspection program, particularly staffing issues related to fill its China and India-based offices. In June and July of 2018 the FDA said the vacancy rate in foreign offices had fallen to 15% from 46% in 2016 and that it had developed new performance measures for these offices, along with a monitoring and evaluation plan.

Grassley, however, still questioned in his latest letter why a 2013 FDA pilot program in India “that eliminated advanced notice and instead used short notice or unannounced visits” was “shut down without explanation” in 2015. He said the pilot “exposed widespread malfeasance” that had otherwise been hidden because of a previous system that allowed advanced warnings for manufacturing sites.