Proposed Measures to Clarify FDA’s Import and Inspection Authority

The FDA moved to close a glaring gap in the agency’s import powers Friday, issuing a proposed rule that grants detention authority for drugs. The agency also issued a draft guidance outlining penalties for refusing, delaying or limiting an FDA inspection.

The proposed measures were mandated by the FDA Safety and Innovation Act (FDASIA) and address a growing and complex supply chain for pharmaceuticals, said FDA Commissioner Margaret Hamburg.

“We now receive imports from more than 150 countries, many with much less sophisticated manufacturing,” she said during a Friday public meeting to get stakeholder input on the new import powers granted by FDASIA. “Over time, our authorities couldn’t keep pace with the challenges of this global marketplace.”

The proposed rule is intended to close a gap in FDA’s import authority. While the agency can detain medical devices and food that inspectors believe are adulterated or misbranded, it has lacked that same power for drugs.