House Committee Wants FDA Drug Inspection Info

Bipartisan leadership of the House Energy and Commerce Committee is asking FDA acting commissioner Janet Woodcock for information on agency efforts to mitigate the backlog of drug manufacturing facility inspections and human drug applications to ensure patient access to safe and effective medicines. A 7/22 letter says committee members are concerned that the nation has not yet seen the full impact of inspections delayed by Covid-19, particularly in the case of preapproval inspections. “Drug applications and approvals may be affected in the future if inspections continue to be postponed, possibly delaying patient access to needed medications,” the letter says. It also refers to a Government Accountability Office report that the agency will face future challenges with its drug approval and surveillance oversight activities if inspection delays continue.

The letter requests responses to 13 detailed questions.