Drugs

FDA Planning Foreign Inspection Improvement Pilots

FDA is planning several pilot programs to test ways to improve foreign inspections, agency staff have told Bloomberg Law. For an online story, Bloomberg talked to several attorneys about the foreign inspection program and the need for improvements. The attorneys said that increasing agency staff, using unannounced inspections, and hiring more independent translators could lead to more accurate FDA reviews.

A February Government Accountability Office (GAO) report said FDA has improved its oversight on foreign drug manufacturing over the last 20 years, but cited ongoing issues with workforce retention and maintaining a regular inspection timeline.

Some attorneys interviewed by the news service said the agency should use more remote surveillance activities and ask for help from third-party auditors to conduct on-site inspections. Others said that only in-person inspections by FDA staff can meet the standard necessary for product approvals.

FDA spokeswoman Audra Harrison said the agency is developing an “unannounced foreign inspection program as [it] increases recruitment and retention efforts for the FDA foreign workforce.”

The attorneys described workforce issues and the article says FDA reported that translation services is one area it is targeting for improvement.

Bloomberg also reports that FDA plans to launch a pilot program focused on increasing its connection with independent translators, including through a partnership with the State Department. Another pilot program will analyze the benefits and weaknesses of unannounced foreign inspections, although the GAO report said specific details on the initiative’s design were not finalized as of 9/2021.

While some observers have urged more use of virtual inspections, Harrison said the agency has begun a multi-year modernization effort including remote approaches. But, she said, FDA believes “remote interactive evaluations do not replace inspections and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome