It is rare that we urge our readers to keep a copy of a court ruling or brief. A Brief that FDA filed on August 21, 2014 is an exception. Companies and others should read this brief and keep it close at hand. When someone wants to question FDA’s legal authority to compel a recall, this brief provides the clearest statement of FDA’s limited authority to compel a recall.
We previously described (here and here) the litigation commenced by Hospira, Inc. (“Hospira”) wherein the company filed suit against FDA following the Agency’s approval of generic PRECEDEX (see FDA Dear Dexmedetomidine Hydrochloride Injection NDA Holder/ANDA Applicant Letter (Aug. 18, 2014) (hereinafter “FDA Letter Decision”)). In summary, Hospira sought, and was granted, a Temporary Restraining Order (“TRO”) that included a stay of FDA’s Letter Decision, rescission of any ANDA approvals predicated upon that Letter Decision, an order that FDA recall any product sold or distributed under such an ANDA approval, and an injunction prohibiting FDA from granting any further or additional approvals predicated upon the Letter Decision. The court order directing FDA to recall a drug product based on a Hatch-Waxman dispute was unprecedented.
Generally speaking, FDA cannot compel a mandatory recall, except in very limited circumstances as authorized by statute, none of which apply to drugs (see here at § 7-5-3). FDA can order a recall when the Agency:
- finds there exists a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death (21 U.S.C. § 360h(e)(1));
- determines that a batch, lot, or other quantity of a biological product presents an imminent or substantial hazard to the public health (42 U.S.C. § 262(d)(1));
- determines that an adulterated or misbranded infant formula presents a risk to human health (21 U.S.C. § 350a(e); see also 21 C.F.R. § 107.200);
- finds there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death (21 U.S.C. § 387h(c)(1)); or
- determines there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (21 U.S.C. § 350l(a));
Finally, FDA has the discretion to compel a mandatory recall when it finds that a human cell, tissue, or cellular and tissue-based product is a source of dangerous infection to humans, or does not provide adequate protections against the risks of communicable disease transmission.
Recalls, in situations other than those described above, are voluntary actions by a company expected to conform to FDA policy set forth in its regulations.
Thus, as we circle back to the Hospira litigation, we arrive at a threshold question: can a court order FDA to order a recall? The answer from the Defendant-Intervenors as well as FDA in this case is no. FDA states clearly and succinctly in its Brief: “FDA cannot order recalls.” The Agency goes on to argue that the recall ordered in the Hospira TRO could not even be requested by FDA because the basis for the recall was a patent dispute and not a matter of product safety or efficacy. FDA says: “consumers should believe that recalled products present a risk to health or are grossly deceptive. That is decidedly not the case here.” The Agency admitted that “[i]f a company chooses not to comply with an FDA request to recall, FDA has no mechanism to enforce its request because it does not have statutory authority to order drug recalls.” FDA also argued that the court-ordered recall was not in the public interest because the recall “threaten[ed] to disrupt the consistent regulatory standards for recalls.” Finally, the Agency makes the argument that a recall based, such as this, on a patent issue and not on a product safety or efficacy issue will undermine the perception of future recalls. To this point, FDA says: “When other future products are recalled, consumers may question whether the recall is related to a legitimate public health concern, or whether it is merely another patent dispute in which safety or efficacy is not at issue. The public interest weighs strongly against” ordering a recall.
The district court held a hearing on August 26, 2014 to decide on a Motion for Reconsideration of the TRO entered on August 19th. In the end, the court granted the Motion for Reconsideration in part and vacated that part of the TRO that ordered FDA to compel a recall of generic PRECEDEX.