FDA official offers compliance updates, discusses enforcement misperceptions

The US Food and Drug Administration (FDA) recently launched a new web page to combat misperceptions about drug compliance actions, said Jill Furman, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research (CDER). She also noted that FDA is continuing to rely on the use of alternatives tools, such as remote interactive evaluations, and is using those methods as the basis for issuing warning letters and import alerts.

Furman discussed some recent activities related to the Office of Compliance’s work at the recent Regulatory Education for Industry (REdI) meeting on 30 May. Furman noted that “there are a lot of misconceptions” about FDA’s compliance work.

Furman also noted that FDA is continuing to rely on remote tools, such as reviewing a firm’s written response to a record’s request or through remote inspections instead of conducting onsite inspections as the basis for issuing warning letters and import alerts.

In FY 2024, 75% of the import alerts stemmed from the use of these remote tools while 23% stemmed from onsite inspections, and 2% came from sample testing. In FY 2020, only 5% of import alerts stemmed from the use of remote tools while 56% resulted from onsite inspections and 39% resulted from product testing.

FDA is also continuing to rely heavily on these tools in issuing warning letters. In FY 2024, 66% of warning letters were prompted by an onsite inspection while 29% resulted from the use of remote tools. This contrasts with FY 2020 where 98% of the warning letters were prompted by an onsite inspection and 2% were based on FDA sample testing.

FDA launched a webpage in March to address these misperceptions related to its oversight of drug quality. The webpage provides an overview of the agency’s work in monitoring drug manufacturers' compliance with current good manufacturing practice (CGMP) and includes information on warning letters, and actions following a CGMP inspection. It also links to the FDA data dashboard page with compliance actions.

One of these misperceptions is that FDA has the authority to recall drugs. Instead, FDA can request that firms remove violative drugs, but it does not have mandatory authority to recall drugs. Another faulty perception is that FDA tests all drugs that are on the market. Instead, FDA uses a risk-based approach to decide which firm to inspect, those that pose a high risk are the first to be inspected.

Furman said there “are a host of other misperceptions” concerning the inspections process and Form 483 reports and inspection classifications.

REdI meeting

FDA official offers compliance updates, discusses enforcement misperceptions

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