The proposed rule issued last Friday, which was called for under legislation known as FDASIA (Food and Drug Administration Safety and Innovation Act), would allow the agency to detain potentially adulterated or misbranded drugs for up to 20 calendar days, though an additional 10 days may be added if an FDA district director determines more time is needed to seize drugs, institute injunction proceedings or to evaluate legal action.
The detention periods are intended to give the FDA more time to assess what to do with drugs that might be adulterated or misbranded and how to charge the company that produced them.
“This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded,” the agency said.
Any person or company entitled to claim the drugs may also appeal a detention order within five working days of the detention order. The FDA estimates it could cost the agency more than $590,000 annually to mark or label the detained products and costs associated with appeals of detention orders.
The rule is now open to 60 days of public comment.
New Guidance on Inspections
In addition to the rule, the FDA also last week released draft guidance that aims to tighten its authority over manufacturers by detailing circumstances when a manufacturer could delay, deny, limit or refuse an inspection.
The nine-page document offers a number of different scenarios where a manufacturer’s actions would be considered reasonable, as well as other cases where its actions would lead to drugs at the facility to be considered misbranded or .
The FDA says that it understands minor delays “that result from good faith efforts by the facility to comply with FDA requests” prior to an inspection. However, inspection delays that may cause drugs to be considered adulterated include, but are not limited to:
- A facility that restricts an FDA investigator’s access to an area of the facility until a specific future date or time even though the area is operational; or
- A facility that leaves an FDA investigator in a conference room without access to necessary documentation or responsible individuals for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection.
Delays in providing the FDA with records or documents without a reasonable explanation may also be considered delaying an inspection.
Rejecting the FDA’s attempt to schedule an inspection, preventing access to certain areas of a manufacturing site or stopping an inspection from beginning are other common examples of behavior that may cause drugs to be considered adulterated.
Limiting the use of photographs, which the FDA considers “an integral part of an FDA inspection because they present an accurate picture of facility conditions” may also cause a facility’s drugs to be considered adulterated. The FDA lists examples of times it documented poor conditions, including “evidence of rodents or insect infestation; faulty construction or maintenance of equipment or facilities; product storage conditions; product labels and labeling; and visible contamination of raw materials or finished products.”
Comments on the draft guidance are due September 15.