The FDA's proposed rules implementing its new detention authority with respect to drugs appear to present a new risk to facilities during inspections.
On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the integrity of the drug supply chain—specifically, Section 709 of the FDASIA [amending section 304(g) of the Food, Drug, and Cosmetic Act (FDCA)]. The proposed rules provide the FDA with the administrative authority to detain drugs the FDA believes are either adulterated or misbranded. The FDA will detain the drugs until it considers what action it should take concerning the drugs, whether legal or otherwise.1 The goal of this detention authority has been stated by the FDA as follows: "to protect the public by preventing distribution or subsequent of use of drugs ... that are believed to be adulterated or misbranded ... ." Comments on the proposed rule are due no later than September 13, 2013.
Scope of the FDA's New Detention Authority for Drugs
Circumstances Meriting a Detention Order. The proposed rules permit the FDA to detain drugs when an FDA employee or officer has reason to believe that the drug is adulterated or misbranded, based on the employee's or officer's inspection under Section 704 of the FDCA.2 This belief of adulteration or misbranding is the only criterion necessary for issuance of a detention order. A detention order will be issued in writing by the authorized FDA official who has reason to believe of the adulteration/misbranding.
Length of Detention Order. The detention order may last for a period of up to 20 days. The FDA may also authorize a detention for an additional 10 days if greater time is needed to seize the drugs, to seek an injunction or to evaluate the need for legal action.
Effect of Detention Order. Once issued, the detention order prevents the detained drugs from being used, moved, altered or tampered with in any manner, as long as the detention order is in effect or until an FDA official authorizes the movement of the drugs. The FDA may authorize the movement of detained drugs in four situations: (1) to prevent interference with an establishment's operations or harm to the drugs; (2) to destroy the drugs; (3) to bring the drugs into compliance; or (4) for any other purpose appropriate to the case.
Recordkeeping Requirements. The proposed regulations also impose recordkeeping requirements on owners, operators or agents in charge of any affected facility. Specifically, the proposed regulations require the facility to maintain adequate records relating to how the detained drugs may have been adulterated/misbranded; records on distribution of the drug before and after the detention order; and records of movement of the detained drugs, among other things. These records must be retained for at least two years after the issuance of the detention order, unless otherwise directed by the FDA.
Appeal Rights. Affected facilities may also appeal the issuance of a detention order. The appeal request must be submitted within five days of receipt of the detention order and may request that an informal hearing occur between five and 20 days of receipt of the detention order. Appeals must be decided within five days after the filing of an appeal or conclusion of an informal hearing.
Conclusion
The FDA's proposed rules implementing its new detention authority with respect to drugs appear to present a new risk to facilities during inspections. Facility owners should consider closely analyzing these risks prior to an inspection and developing a quick response to a detention order.
About Duane Morris
Duane Morris attorneys counsel clients in the pharmaceutical industry on virtually all aspects of their business and at all stages of the client's lifecycle, from bringing new products to market, review of promotional materials, price reporting, adverse event reporting, import and export issues and manufacturing questions, to conducting self-evaluative audits and designing corrective action plans. Duane Morris also regularly assists clients in dealing with governmental regulatory agencies—including the FDA, DEA, CMS, OIG, HHS, DOJ, the FDA Office of Criminal Investigations and state regulatory authorities—in matters involving regulatory enforcement actions, False Claims Act litigation, internal investigations, fraud and abuse, off-label promotion and federal and state anti-kickback statutes.
Notes
- The FDA already has this detention authority with respect to devices, food and tobacco products.
- Section 704 of the FDCA permits the FDA to enter facilities that manufacture, process, pack or hold foods, drugs, medical devices or cosmetics; and to inspect equipment, finished and unfinished materials, containers and labeling as appropriate. FDCA Section 704(a)(1); 21 U.S.C. Section 374 (a)(1).
This article is for general information and does not include full legal analysis of the matters presented. It should not be construed or relied upon as legal advice or legal opinion on any specific facts or circumstances. The description of the results of any specific case or transaction contained herein does not mean or suggest that similar results can or could be obtained in any other matter. Each legal matter should be considered to be unique and subject to varying results. The invitation to contact the authors or attorneys in our firm is not a solicitation to provide professional services and should not be construed as a statement as to any availability to perform legal services in any jurisdiction in which such attorney is not permitted to practice.
Duane Morris LLP, a full-service law firm with more than 700 attorneys in 24 offices in the United States and internationally, offers innovative solutions to the legal and business challenges presented by today's evolving global markets. Duane Morris LLP, a full-service law firm with more than 700 attorneys in 24 offices in the United States and internationally, offers innovative solutions to the legal and business challenges presented by today's evolving global markets. The Duane Morris Institute provides training workshops for HR professionals, in-house counsel, benefits administrators and senior managers.
