Holidays and Red Herrings: FDA’s “Nonenforcement Discretion” Successfully ChallengedMay 21, 2019
Historically, the Food and Drug Administration has called its decisions not to pursue enforcement against or prosecution of legal violations an exercise of “enforcement discretion,” which is a misnomer. In reality, such decisions are an exercise of “nonenforcement discretion.” But, whatever it is called, rarely do federal courts rule that FDA must take enforcement actions against violative products.
There have been some exceptions. See, for example, the decision by Judge Leon of the federal district court in the District of Columbia about FDA’s failure to ban imports of a lethal drug (thiopental) used in prisoner executions, which we blogged about here, and which was affirmed by the D.C. Circuit Court of Appeals. Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff’d, 733 F.3d 1 (D.C. Cir. 2013). In the same current, but bucking a tidal wave of contrary decisions refusing to order FDA to take enforcement action, comes a recent decision by Judge Grimm in federal court in Maryland, holding that FDA cannot delay or relax enforcement requirements mandated by the Tobacco Control Act, and holding that FDA must require manufacturers of tobacco and other nicotine products (with grandfathered exceptions) to submit applications to market those products before FDA’s announced deadline of 2021 and 2022. Mem. Op., Am. Acad. of Pediatrics v. FDA, No. PWG-18-883 (D. Md. May 15, 2019) [hereinafter “Grimm Mem. Op.”].
At issue was an FDA August 2017 Guidance that postponed deadlines until at least 2021 or 2022 for manufacturers and distributors of e-cigarettes (and other types of nicotine-containing products) to submit applications for marketing approval, pursuant to the “Deeming Rule” that we blogged about here. Judge Grimm held that the plain language of the Tobacco Control Act prohibits relevant products “from entering the market without the FDA’s approval,” and that FDA’s “‘wholesale suspension’ of the application filing and approval requirements constitutes a rule amendment or revocation that is subject to review by this Court.” Grimm Mem. Op. at 32. Judge Grimm’s opinion went on to hold that “the FDA ‘must’ require filings from manufacturers and approve or deny those filings, that is, it must take actions that are ‘necessary to fulfilling the purposes of the [Tobacco Control] Act.’” Id. at 33. FDA’s announcement “in the August 2017 Guidance that certain products that had been deemed to be tobacco products could remain on the market for five years or more without premarket review” was a “‘definitive legal position’ regarding its statutory authority . . . that certain products that had been deemed to be tobacco products could remain on the market for five years or more without premarket review.” Id. at 40. He held that FDA’s position “defeats, rather than furthers, the purpose of the Tobacco Control Act by allowing unapproved tobacco products to be manufactured, advertised, and sold for five years or longer.” Id. at 44.
Judge Grimm noted that “the Supreme Court ‘has recognized on several occasions over many years that an agency’s decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency’s absolute discretion.’” He cited the decision in Heckler v. Chaney, 470 U.S. 821 (1985), the landmark case on unsuccessful efforts to secure a court order requiring FDA to ban allegedly violative products (Chaney was brought by prison inmates seeking administrative action banning drugs used to administer lethal injections). But, said, Judge Grimm, Chaney stands only for the proposition that “FDA may decide not to enforce the provisions of the Tobacco Control Act with regard to specific products,” and does not support FDA’s “decision to hold in abeyance” for five or more years “enforcement of mandatory provisions of a statute that Congress viewed as integral to address public health dangers [especially from e-cigarettes and other vaping products] that the agency itself acknowledges are alarming.” Grimm Mem. Op. at 45-46. Judge Grimm said that it is not sufficient for FDA to claim it needs “five or more years while it tries to figure out how it will implement the statute, all the while affording those manufacturers responsible for the public harm a holiday from meeting the obligations of the law.” Id. at 46. In other words, Judge Grimm said, the assertion of “enforcement discretion” in this case is a “red herring.” Id. at 45.
FDA had argued to Judge Grimm that the August 2017 Guidance was a policy statement and therefore not a final agency action, so the court had no business considering whether it was legal. Judge Grimm rejected that argument, holding that “the August 2017 Guidance is not a policy statement; it is tantamount to an amendment to the Tobacco Control Act.” Id. at 52. The “August 2017 Guidance implements ‘changes to the statutorily established process,’” he continued, and “[t]hose changes have ‘legal consequences.’” Id.
This blogpost is not a law review article. But it bears mentioning that Judge Grimm’s decision brooks a large number of cases in which a court has refused to order FDA to enforce the law. Years ago, our firm tried to convince a court to order FDA to decide whether to pull generic drug marketing exclusivity from Ranbaxy for its serious data integrity and other manufacturing violations, a request that was denied. Mylan Pharms. v. FDA, 789 F. Supp. 2d 1 (D.D.C. 2011). Curiously enough, our firm then represented a different client, allied with FDA, when FDA decided to pull exclusivity on esomeprazole manufactured by Ranbaxy for the same reasons (see here). Mem. Op., Ranbaxy Labs, Ltd. v. Burwell, No. 14-1923 (BAH) (D.D.C. Mar. 11, 2015). In addition to Chaney, the following are selected cases that upheld FDA inaction:
- The D.C. Circuit Court of Appeals in Community Nutrition Institute v. Young, 818 F.2d 943, 950 (D.C. Cir. 1987), refused to order FDA to take action against the blending of “contaminated corn with uncontaminated corn,” saying that “FDA enjoys complete discretion not to employ the enforcement provisions of the FDC [Food, Drug, and Cosmetic] Act, and those decisions are not subject to judicial review.”
- The same court ruled in Cutler v. Hayes, 818 F.2d 879, 892 (D.C. Cir. 1987), that it could not order FDA to take enforcement action against “an OTC [over-the-counter] drug that is safe but demonstrably ineffective for its intended use.”
- A court in the Western District of Michigan (Judge Bell) refused a request from Pan American Pharmaceuticals, Inc. that FDA be required to “enforce the pre-approval provisions for new animal drugs against all persons.” Order, Pan Am. Pharms., Inc. v. Kessler, No. 90-1063 (W.D. Mich. Mar. 4, 1991).
- K-V Pharmaceutical Co. tried, and failed, to secure a court order that FDA should pursue pharmacy compounders that were making copies of its approved drug Makena. K-V Pharm. Co. v. FDA, 889 F. Supp. 2d 119, 137 (D.D.C. 2012). (the decision was vacated and remanded, citing Cook v. FDA, 733 F.3d 1 (D.C. Cir. 2013) (the appellate decision on Beaty), and the Drug Quality and Security Act, Pub. L. No. 113-54, 127 Stat. 587 (2013); the case was eventually dismissed with prejudice in July 2014).
- Reversing a district court decision, Natural Resources Defense Council v. FDA, 760 F.3d 151 (2d Cir. 2014), held that a court could not order FDA to renew proceedings to determine whether FDA should withdraw approval of use of penicillin and tetracycline in livestock for subtherapeutic purposes.
- In a case we blogged about here, a court in California held that FDA would not be ordered to require egg producers to label commercial eggs as being from “free range” or “cage free” hens, or from “caged hens.” Compassion over Killing v. FDA, No. 13-cv-01385-VC (N.D. Cal. Dec. 19, 2014).
Judge Grimm has ordered the parties to submit briefs about what remedy he should order, and that process starts within a couple of weeks.
We should also note that our firm has represented clients that manufacture or distribute products that contain tobacco or nicotine. Our practice is more fully described here.