Significant Additions to the Food and Drug Administration Safety and Innovation Act (FDASIA)

FDA hosted a public meeting on July 12, 2013 to discuss how the FDA might implement some of the other portions of Title VII specifically Section 7.13 Standards for Admission of Imported Drugs and Section 714 Registration of Commercial Importers and Good Importer Practices. FDA Commissioner Margaret Hamburg said during the meeting that administrative detention regulations for drugs will allow FDA to exercise the same authorities it has for food and medical devices, which are already subject to administrative detention and allow the agency to penalize manufacturers that interfere with FDA inspections.

“This is another significant tool for managing the supply chain because it will help ensure more immediate and consistent enforcement of the law,” Hamburg said of the guidance, adding that the provisions were the first two of several mandated actions the action would take on supply chain quality and security.

On July 15, 2013 the FDA published two items in the Federal Register that are required to implement sections of Title VII of FDASIA and strengthen the security of the pharmaceutical supply chain.  These represent two new powers given to FDA in FDASIA.  One is a proposed rule and the other is a draft guidance.  The comments on the proposed rule are due September 15, 2013 and comments on the guidance are due to FDA on September 13, 2013. Both items are summarized below:

Proposed Rule:  Administrative Detention of Drugs Intended for Human or Animal Use (FR Vol. 78, No. 135, pages 42382-42386, July 15, 2013)

The FDA currently has authority to administratively detain devices, tobacco and foods, but does not have this authority with regard to drugs.  FDA is proposing this rule to implement section 709 of FDASIA.  When finalized, this rule will allow FDA to “administratively detain drugs encountered during an inspection that an officer or employee conducting an inspection has reason to believe are adulterated or misbranded.”  Further, the proposed rule states that “…administrative detention is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that may be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.”  The proposed rule specifies:

  • the duration of administrative detention cannot exceed 30 days unless otherwise officially extended
  • the content of the detention order including the reason for detention, identification of the detained drugs, time/date of the detention order and details on appeals to this detention
  • how product subject to the detention order must be labeled/marked
  • how to appeal the detention order
  • how detained drugs may be moved
  • other actions that may be implemented involving adulterated or misbranded drugs
  • how the order may be terminated

Draft Guidance for Industry;  Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (FR Vol. 78 No. 135, page 42387, July 15, 2013)

This draft guidance is published in support of section 704 and 707 of FDASIA which state that refusal of inspection is subject to criminal penalties and that a drug is deemed to be adulterated if an “…establishment delays, denies or limits an inspection , or refuses to permit entry or inspection”  respectively. The guidance identifies actions that FDA will consider in making a decision that an inspection has been delayed or denied.  The guidance provides examples of what constitutes the following actions:

  • Delay of inspection for preannounced inspections, delay during an inspection and delay in producing records
  • Denial of Inspection
  • Limiting of inspection including limiting access to the facility and manufacturing process, limiting photography, limiting access to or copying of records, and limiting or preventing sample collection
  • Refusal to permit entry or inspection

Read more about the legislation here.