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Keeping Track of the Quacks: Drug and Device Enforcement in the COVID-19 Era by Beth Weinman, Josh Oyster, and Meighan Parker

Introduction Federal Food, Drug and Cosmetic Act (FDCA) or federal In February 2020, the Secretary of the Department of Health mail and wire fraud statutes where “quackery” may be a par- and Human Services (HHS) declared a public health emergen- ticularly apt description of the alleged conduct. However, we cy involving the virus that causes COVID-19.1 Unfortunately, expect that at some point the government will pivot towards the public health emergency has provided seemingly fertile cases involving subtler theories of potential deception or ground for nefarious characters to prey upon mass uncertainty failures to comply with applicable regulatory requirements. and consumer fear for their own personal gain. To protect This article reviews key COVID-19-related DOJ and FDA en- consumers from fraudulent medical products during the forcement actions to date, makes predictions regarding what COVID-19 pandemic, the U.S. Food and Drug Administra- the next wave of federal government enforcement may look tion (FDA) launched “Operation Quack Hack.”2 Similarly, the like, and recommends best practices for ensuring compliance Department of Justice (DOJ) has prioritized the investigation with FDA requirements for the duration of the pandemic and and prosecution of fraudulent or otherwise unfair practices re- beyond. 3 lated to COVID-19. DOJ has established hotlines for reporting Overview of DOJ and FDA Enforcement 4 COVID-19 fraud as well as hoarding and price-gouging. The Actions During COVID-19 government has sought injunctions and even brought criminal Since the start of the pandemic, FDA and DOJ have used a charges against defendants seeking to exploit the public health range of regulatory and judicial tools to stop the distribution of emergency by touting unapproved and sometimes danger- ous drugs promising to prevent or cure COVID-19 or selling fraudulently labeled personal protective equipment (PPE). Ad- Beth Weinman is counsel at Ropes & Gray LLP. She is member of the ditionally, FDA, often in conjunction with the Federal Trade firm’s life sciences and FDA regulatory Commission (FTC), has issued more than 100 warning letters practice group. She focuses her practice for products intended for COVID-19 uses. on FDA regulation and enforcement To date, enforcement actions related to COVID-19 have of laws governing pharmaceuticals, biologics, medical devices, and dietary primarily involved allegations of egregious violations of the supplements.

10 Update Fall 2020 www.fdli.org Drug and Device Enforcement

false COVID cures and other defective and mislabeled products, describing a firm’s corrective actions demonstrates the urgency warn consumers about them, and try to deter future misconduct. with which FDA is acting to ensure that firms remove unap- proved products from the market promptly. Regulatory Enforcement FDA has also used its public perch to issue safety alerts warn- As of August 26, 2020, FDA has issued 111 warning letters— ing the public against the use of certain unapproved, potentially eighty jointly with the FTC—to companies involved in the mar- dangerous products. For example, FDA warned against the use keting of unapproved products for uses related to COVID-19, of hand sanitizer products containing wood alcohol following the vast majority making drug claims. Products highlighted in reports of adverse events including blindness, hospitalizations, the COVID-19 warning letters include, among others, essential and death. FDA recommended that numerous firms recall these oils, colloidal silver, teas, and dietary supplements marketed products and also added foreign makers of such products to an with claims to prevent, treat, mitigate, or cure COVID-19. With import alert to prevent the products from entering the U.S.6 respect to devices, FDA has issued three warning letters related to the marketing of unapproved COVID-19 antibody tests for Judicial Enforcement at-home use.5 As summarized in the table below, DOJ has filed eight civil in- While warning letters typically request a response from firms junction actions and eleven criminal actions relating to alleged within fifteen business days, FDA’s warning letters related to violations of the FDCA or otherwise fraudulent marketing of COVID-19 have generally insisted on responses within for- products intended for uses related to COVID-19.7 ty-eight hours of receipt. This accelerated timeline for responses

Case Type 8 Count Specific Cases Civil Injunction (FDCA) 2 U.S. v. Xephyr LLC, No. 20-cv-00140 (E.D. Okla.) U.S. v. Genesis II Church of Health and Healing, No. 20-cv-21601 (S.D. Fla.) Civil Injunction (Mail and/or Wire 6 U.S. v. Flint, No. 20-cv-00489 (W.D. Ky.) Fraud9) U.S. v. My Doctor Suggests LLC, No. 20-cv-00279 (D. Utah) U.S. v. Nannis, No. 20-cv-00940 (N.D. Tex.) U.S. v. Purity Health and Wellness Centers, Inc., No. 20-cv-00985 (N.D. Tex.) U.S. v. Tatum, No. 20-cv-00907 (W.D. Tex.) U.S. v. Travalino, No. 4:20-cv-00046 (W.D. Tex.) Criminal (FDCA) 10 U.S. v. Crawford Technology (HK) Co., Ltd., No. 20-mj-15272 (D.N.J.) U.S. v. Grenon, No. 20-mj-03050 (S.D. Fla.) U.S. v. King Year Printing and Packaging Co., Ltd., No. 20-mj-00416 (E.D.N.Y.) U.S. v. Marschall, No. 20-mj-05097 (W.D. Wash.) U.S. v. My Doctor Suggests LLC, No. 20-cr-00215 (D. Utah) U.S. v. Nyachira, No. 20-cr-00275 (E.D. Mo.) U.S. v. Owens, No. 20-mj-00107 (D. Or.) U.S. v. Pedersen, No. 20-cr-00216 (D. Utah) U.S. v. Ryncarz, No. 20-cr-75 (S.D. Ga.) US. v. Tieu, No. 20-cr-00109 (E.D. Cal.) Criminal (Mail and/or Wire Fraud Only) 1 U.S. v. Staley, No. 20-cr-01227 (S.D. Cal.)

Josh Oyster is an associate at Ropes & Meighan Parker is an associate in Gray LLP. His practice focuses on a wide Ropes & Gray’s life sciences and range of regulatory and compliance regulatory compliance group. She issues faced by life sciences and health provides regulatory counsel on issues care companies regulated under the involving promotional compliance Federal Food, Drug, and Cosmetic Act materials and regulatory risk (FDCA) and related laws. management.

FDLI Fall 2020 Update 11 Drug and Device Enforcement

Several cases involving particularly court in Maine against DOJ and FDA, thresholds, rendering their labeling false brazen allegations are described below. claiming, among other things, “trespass and misleading.20 against rights with intent” and unlawful Similarly, a second manufacturer, King Genesis II Church of Health and seizure and deprivation of “God-given Year, allegedly imported approximately Healing (Genesis II) unalienable rights” and rights afforded 500,000 respirators with “N95” markings In April 2020, FDA sent a warning letter under various sections of the U.S. Con- and product labeling that included a test to Genesis II relating to its marketing stitution.16 report falsely showing compliance with of “Miracle Mineral Solution” (MMS) Though the outcome of the criminal the N95 filtration standard when testing as a treatment for COVID-19 and other case—and the follow-on civil lawsuit by conducted by the government established conditions. MMS is an oral solution that Genesis II—remains to be seen, the al- that the masks did not meet this stan- converts to a hazardous bleach prod- legations outlined in the civil injunction dard.21 DOJ also charged King Year with uct when combined with an activator. and criminal case may help explain why making false statements by filing a false FDA had previously warned consumers FDA’s COVID-19 enforcement initiative registration document with FDA claim- in August 2019 about the potentially is named “Operation Quack Hack.” The ing that the respirators were “NIOSH-ap- life-threatening effects of MMS, includ- cases also demonstrate that the govern- proved N95 respirators” and by utilizing ing severe vomiting, dehydration, and ment is directing resources to matters a fictitious corporation as its U.S. agent in 10 acute liver failure. that involve allegations of both signifi- those registration documents.22 After Genesis II refused to cease distri- cant fraud and significant harm. A Wall Street Journal analysis found bution of MMS following the April 2020 that King Year and Crawford, in addition Crawford Technology and King warning letter, DOJ sought an injunction to approximately 1,300 other Chinese en- Year Printing and Packaging under the FDCA against Genesis II and tities, allegedly named the same fabricat- its founders, the Grenon family. DOJ DOJ has also filed criminal charges ed entity, with a false address, as the U.S. alleged that the MMS sold by the defen- against entities involved in the manu- agent in their respective FDA registration dants was an unapproved new drug that facture, promotion, and distribution of statements.23 This issue potentially raises 11 had false and misleading labeling. The misbranded and adulterated filtering concerns about whether those companies district court for the Southern District facepiece respirators (FFRs). In sepa- are falsifying other information in their of Florida enjoined the defendants from, rate criminal complaints, two Chinese registration documents and whether they among other things, selling an unap- companies, Crawford Technology Group are also selling PPE or other products 12 proved or misbranded drug like MMS. (HK) Co., Ltd. (Crawford) and King that fail to meet the quality and efficacy Genesis II and the Grenon family Year Printing and Packaging Co., Ltd. standards on their labeling. refused to comply with the court order, (King Year), were charged with violating claiming, among other things, that the the FDCA by introducing misbranded Huu Tieu government has no authority over their and substandard FFRs into interstate Huu Tieu, the president and chief “church.”13 Consequently, the defendants commence.17 executive officer of Golden Sunrise were charged criminally in the same According to the criminal complaint Pharmaceutical Inc. and Golden Sunrise court with conspiracy to introduce a mis- against Crawford, the firm allegedly Nutraceutical Inc., was indicted in July branded drug into interstate commerce manufactured and shipped 140,400 mis- 2020 for allegedly committing mail fraud and to defraud the U.S. government, branded and adulterated KN95 respira- and introducing a drug into interstate and with criminal contempt for willfully tors to the United States.18 The packaging commerce that was misbranded because violating the injunction.14 The criminal of those respirators represented that the it fraudulently promoted the drug for the complaint also explained that the defen- devices had a 95% filtration efficiency treatment of a variety of medical con- dants had informed the judge presiding and were compliant with the regulatory ditions, including COVID-19.24 He al- over the civil case that they would not standards for respirators in the European legedly claimed that one of the mixtures, comply with the court’s injunction and Union and China.19 However, the respira- referred to as “ImunStem,” was the first had threatened violence.15 Two weeks tors allegedly did not meet the applicable dietary supplement to gain FDA approval after the criminal charges were filed, filtration standard when tested and were, as a prescription drug to treat HIV, can- Genesis II filed a civil lawsuit in federal in fact, significantly below the required cer, and COVID-19.25 Tieu also allegedly

12 Update Fall 2020 www.fdli.org Drug and Device Enforcement

claimed that ImunStem was designated to market. Through the False Claims Act pendency of the emergency, so long as as a Regenerative Medicine Advanced (FCA), the government will also likely the conditions in the EUA letter are met. Therapy (RMAT), which would have seek to recover federal dollars paid for Similarly, FDA’s enforcement discretion required that it be a cellular therapy.26 misleadingly labeled or otherwise defec- policies have addressed a wide range of Neither of these claims were true, though tive or non-compliant medical products. products and permitted the marketing of Tieu allegedly sought reimbursement these products, pursuant to enforcement Continued Focus on Sham for ImunStem from insurers as a cellular discretion, under specified conditions Treatments and Other therapy.27 The easily demonstrable falsity during the public health emergency.30 Unapproved Products of Tieu’s affirmative misrepresentations While traditional drug and medical about the FDA regulatory status of his As the U.S. experiences another spike device companies are familiar with FDA products, and the allegation that Tieu in COVID-19 cases, there may be a requirements and the responsibility to defrauded not only consumers but also corresponding surge in the marketing ensure regulatory compliance, firms insurers, may have made Tieu an attrac- of unapproved products for COVID-19. seeking EUAs or marketing products tive target for prosecution. FDA will likely target false or misleading under FDA’s enforcement discretion As shown in these cases, the govern- product claims by actively monitoring policies may be “new” to FDA regulation ment is moving quickly to deliver on its physical locations of retail stores, social and unfamiliar with the complex re- promise to take COVID-19-related fraud media pages, and online marketplaces for quirements that may apply to marketing seriously and to protect consumers from companies that are advertising and ped- an FDA-regulated product. For example, 28 “quack” products. From issuing warn- dling fraudulent COVID-19 products. shortages of face masks, ventilators, hand ing letters to filing civil and criminal The agency has consistently reiterated sanitizers, and various other products complaints, FDA and its law enforcement that there are currently no drugs to treat have spurred new market entrants in partners have pursued pandemic-related or vaccines to treat or prevent COVID-19 those areas. These new entrants may lack drug and device enforcement with vigor, approved in the United States, although a regulatory compliance infrastructure even while juggling numerous other FDA has to date issued five EUAs for with appropriate controls to satisfy ap- competing interests. drug products used in the treatment plicable requirements. While EUAs and of COVID-19, including one for the enforcement discretion policies typically The Next Wave of DOJ and investigational antiviral drug remdesivir relax certain FDA requirements, they do FDA Enforcement 29 and another for convalescent plasma. not waive compliance with all require- Because the COVID-19 public health Moreover, FDA has still not authorized ments. Firms need to understand which emergency is unlikely to resolve quickly, any diagnostic tests for complete use and requirements continue to apply to the and conduct involving both obvious processing at home. products they are marketing. deception and medical products that Material Noncompliance These requirements include, among pose a great risk of harm are both by “New” Entrants to FDA others, adverse event reporting, labeling compelling and relatively easy to prove, Regulation requirements, restrictions on advertising the government will likely continue to FDA has issued many enforcement and promotion, and, potentially, compli- prioritize enforcement in this area. Pre- discretion policies and granted dozens ance with current good manufacturing sumably, however, government attorneys of EUAs for drugs and devices in an practices (cGMP). Importantly, no cur- will eventually move beyond conduct attempt to mitigate product shortag- rent EUAs and none of FDA’s COVID-19 that could be considered “low-hanging es and spur the development of new enforcement policies waive applicable fruit” and will turn to more complicated products and treatments for COVID-19. adverse event reporting requirements, cases. Future enforcement may target FDA has issued EUAs for a wide range of so firms must ensure they have pro- noncompliance with FDA emergency products, including diagnostic tests, PPE, cesses in place to receive, process, and use authorizations (EUAs) or enforce- ventilators, and drugs used in the treat- report adverse events as appropriate for ment discretion policies by new industry ment of patients with COVID-19. These a given product type. Additionally, EUA entrants with immature compliance EUAs enable the products subject to limitations on advertising and promotion programs or veteran entities that let their them to be distributed legally during the include ensuring promotional materials guard down as they try to speed products

FDLI Fall 2020 Update 13 Drug and Device Enforcement

are consistent with the authorized label- first learning of government disapproval under EUAs or FDA enforcement discre- ing, the authorized intended uses, and through a civil or criminal action.”34 tion policies—especially firms that have contain no representations of safety or never previously marketed an FDA-reg- Provision of Non-Conforming or efficacy. Such products should also not be ulated product—can take the following Non-FDCA-Compliant Products marketed as approved or cleared by FDA. actions now to reduce the risk of future Under Government Contracts Firms must carefully review any and all government scrutiny: promotional materials for their products To mitigate COVID-19-related product to ensure they do not trip the limitations shortages, federal agencies awarded • Stay current regarding the terms of in the applicable EUA or enforcement many government contracts to private EUAs and enforcement discretion discretion policies and do not otherwise entities to increase the availability of PPE policies applicable to the firm’s prod- 35 violate the FDCA.31 and testing supplies. However, accord- ucts, as FDA has revised numerous Notably, some EUAs waive compliance ing to a recent letter from the House of EUAs and policies since their original with applicable cGMP requirements (e.g., Representatives Select Subcommittee on issuance. A number of EUAs and the quality system regulation for medical the Coronavirus Crisis to administra- policies have also been revoked, devices). For example, the EUAs for ven- tion officials, the government awarded technically rendering illegal products tilators and certain related accessories, as many of these contracts to newly formed that at one point were permitted to well as serology and molecular diagnostic entities that had never previously been be distributed without objection by 36 tests, tend to exempt manufacturers from awarded a government contract. In FDA. specific quality system requirements with certain cases, these contractors allegedly • Ensure documented processes and respect to the design, manufacture, pack- either failed to provide the promised qualified personnel are in place to aging, labeling, storage, and distribution supplies altogether or supplied low-qual- monitor compliance with the par- of the authorized products in accordance ity products that materially differed from ticular regulatory requirements (e.g., 37 with the EUA.32 On the other hand, the the products promised. For example, adverse event reporting, labeling, ad- current EUAs for drug products do not one entity received a $10 million contract vertising and promotion) that apply waive cGMP requirements. from FEMA to supply test tubes and to the firm’s products. Looking ahead, the government is like- swabs used in COVID-19 diagnostic • Promptly investigate and address ly to scrutinize whether firms marketing testing. Instead of supplying standard any adverse event reports or product products under EUAs or enforcement tubes typically used by laboratories, the quality complaints, including by discretion policies are adhering to appli- contractor allegedly supplied tubes of an reporting those required by law to be cable requirements, particularly in any unsuitable size that were manufactured reported to FDA. Reports of patient cases where such products are suspected in a dirty facility using non-cGMP-com- harm or product defects are a com- of causing patient harm (e.g., hand sani- pliant methods and that may have been mon basis for the initiation of DOJ 38 tizer products containing wood alcohol). contaminated. It would not be surpris- and FDA investigations. Nonetheless, the government is unlikely ing if the recent letter from the House Se- • If the firm wishes to continue to pursue enforcement action for mere lect Subcommittee and the news reports marketing its products after the technical violations of applicable require- upon which it was based triggered com- COVID-19 pandemic, plan ahead for ments. A senior DOJ official recently prehensive investigations into potential the traditional marketing authoriza- explained in public remarks that DOJ’s violations of the FCA, FDCA, and other tion pathway that would apply to the enforcement efforts would be “consistent applicable legal requirements. firm’s products if and when EUAs are with the increased regulatory flexibility Compliance Best Practices terminated and FDA’s enforcement afforded to companies developing and discretion policies are rescinded As the COVID-19 pandemic continues, distributing COVID-19 tests, treatments, following the conclusion of the public government enforcement priorities are and protective equipment.”33 The official health emergency. likely to evolve and expand, as we have added: “When a company seeks in good described in this article. Firms marketing faith to operate within this regulatory While we cannot predict with any products used to help treat, diagnose, framework, it should not have to fear degree of certainty when the COVID-19 cure, prevent, or mitigate COVID-19

14 Update Fall 2020 www.fdli.org Drug and Device Enforcement

pandemic will end, we are confident that brought under federal mail and wire 17. DOJ, “Chinese Manufacturer fraud statutes instead of the FDCA. Charged with Exporting Defective DOJ and FDA will continue to prioritize Though these cases have generally and Misbranded Masks Falsely enforcement against actors they view as involved allegations of fraudulent Purporting to be KN95 Respira- illegally capitalizing on pandemic prof- marketing of products to treat or tors” (June 18, 2020), available at it-making opportunities at the public’s prevent COVID-19 transmission that https://www.justice.gov/usao-nj/pr/ would have constituted violations chinese-manufacturer-charged-ex- expense. Drug and device makers can of the FDCA, the government may porting-defective-and-misbrand- best protect themselves from unwanted have determined that the mail or wire ed-masks-falsely-purporting; DOJ, government scrutiny during these un- fraud violations would be easier to “Chinese Manufacturer Charged with explain and prove. In addition, in the Exporting Misbranded and Defective precedented times by keeping abreast of criminal sphere, DOJ often pursues Masks Falsely Purporting to be N95 regulatory and policy changes, priori- mail and wire fraud violations because Respirators” (June 5, 2020), available tizing transparency, and making sure to convictions will lead to greater jail time at https://www.justice.gov/usao-nj/ than permitted under the FDCA, which pr/chinese-manufacturer-charged-ex- commit the necessary resources to their offers a maximum of three years for a porting-misbranded-and-defec- compliance functions. FDLI felony violation of the Act. tive-masks-falsely-purporting. 8. Information current as of August 26, 18. See Criminal Complaint, United States 1. 85 Fed. Reg. 7,316 (Feb. 7, 2020). 2020. v. Crawford Technology (HK) Co., Ltd., 2. Judy McMeekin & Anand Shah, “FDA 9. 18 U.S.C. § 1345. No. 20-mj-15272 (D.N.J. June 17, 2020). Protects Patients and Consumers from 10. FDA, “FDA Warns Consumers about 19. Id. Fraud During COVID-19” (July 20, the Dangerous and Potentially Life 20. Id. at 12–13. 2020), available at https://www.fda. Threatening Side Effects of Miracle 21. See Criminal Complaint, United States gov/news-events/fda-voices/fda-pro- Mineral Solution” (Aug. 12, 2019), v. King Year Printing and Packaging tects-patients-and-consumers-fraud- available at https://www.fda.gov/ Co., Ltd., No. 20-mj-00416 (E.D.N.Y. during-covid-19. news-events/press-announcements/ June 5, 2020). 3. DOJ, “Principal Deputy Assistant At- fda-warns-consumers-about-danger- 22. Id. torney General Ethan P. Davis delivers ous-and-potentially-life-threaten- 23. See Austen Hufford et al., “Over remarks on the False Claims Act at the ing-side-effects-miracle-mineral. 1,300 Chinese Medical Suppliers to U.S. Chamber of Commerce’s Institute 11. DOJ, “Justice Department Seeks to End U.S.—Including Mask Providers— for Legal Reform” (June 26, 2020), Illegal Online Sale of Industrial Bleach Use Bogus Registration Data” (June available at https://www.justice.gov/ Marketed as “Miracle” Treatment for 12, 2020), available at https://www. civil/speech/principal-deputy-assis- COVID-19” (Apr. 17, 2020), available wsj.com/articles/over-1-300-chi- tant-attorney-general-ethan-p-davis-de- at https://www.justice.gov/opa/pr/ nese-medical-suppliers-to-u-s-includ- livers-remarks-false-claims. justice-department-seeks-end-ille- ing-mask-providersuse-bogus-registra- 4. See DOJ’s Coronavirus Response gal-online-sale-industrial-bleach-mar- tion-data-11591991270. webpage at https://www.justice.gov/ keted-miracle-treatment. 24. DOJ, “Tulare County Man coronavirus. 12. See Order of Perm. Injunction, United Indicted for Falsely Marketing Herbal 5. FDA, “Coronavirus (COVID-19) States v. Genesis II Church of Health Mixtures as FDA-Approved Treat- Update: FDA Issues Warning Letters to & Healing, No. 20-cv-21601 (S.D. Fla. ment for COVID-19” (July 14, 2020), Companies Inappropriately Marketing July 9, 2020); Order of Perm. Injunc- available at https://www.justice.gov/ Antibody Tests, Potentially Placing tion, United States v. Genesis II Church usao-edca/pr/tulare-county-man-in- Public Health at Risk” (June 17, 2020), of Health & Healing, No. 20-cv-21601 dicted-falsely-marketing-herbal-mix- available at https://www.fda.gov/ (S.D. Fla. Aug. 3, 2020). tures-fda-approved-treatment. news-events/press-announcements/ 13. See Criminal Complaint, United States 25. See Indictment at 8–10, United States v. coronavirus-covid-19-update-fda-is- v. Grenon, No. 20-mj-03050 (S.D. Fla. Tieu, No. 20-cr-00109 (E.D. Cal. July sues-warning-letters-companies-inap- June 30, 2020). 9, 2020). propriately-marketing-antibody. 14. DOJ, “Father and Sons Charged in 26. Id. 6. FDA, “Coronavirus (COVID-19) Miami Federal Court with Selling 27. Id. Update: FDA Reiterates Warning Toxic Bleach as Fake ‘Miracle’ Cure for 28. FDA, “Beware of Fraudulent Corona- About Dangerous Alcohol-Based Covid-19 and Violating Court Orders” virus Tests, Vaccines and Treatments” Hand Sanitizers Containing Methanol, (July 8, 2020), available at https://www. (last visited July 29, 2020), available at Takes Additional Action to Address justice.gov/usao-sdfl/pr/father-and- https://www.fda.gov/consumers/con- Concerning Products” (July 27, 2020), sons-charged-miami-federal-court-sell- sumer-updates/beware-fraudulent-coro- available at https://www.fda.gov/ ing-toxic-bleach-fake-miracle-cure. navirus-tests-vaccines-and-treatments. news-events/press-announcements/ 15. See Criminal Complaint, United States 29. See, e.g., FDA, “Emergency Use coronavirus-covid-19-update-fda-reit- v. Grenon, No. 20-mj-03050 (S.D. Fla. Authorization for Remdesivir” (May erates-warning-about-dangerous-alco- June 30, 2020). 1, 2020), available at https://www.fda. hol-based-hand-sanitizers. 16. See Civil Complaint, Genesis II Church gov/media/137564/download; “Emer- 7. Notably, six of the injunctive actions of Health & Healing v. DOJ, No. 20-cv- gency Use Authorization for COVID-19 and one of the criminal cases were 00253 (D. Me. July 20, 2020). Convalescent Plasma” (Aug. 23, 2020),

FDLI Fall 2020 Update 15 Drug and Device Enforcement

available at https://www.fda.gov/ FDA, FTC, and DOJ under applicable civil/speech/principal-deputy-assis- media/141477/download. consumer protection and fraud statutes. tant-attorney-general-ethan-p-davis-de- 30. On August 19, 2020, the Department of 31. Id.; see also FDA, “Emergency Use livers-remarks-false-claims. Health and Human Services posted a Authorization for SARS-CoV-2 RNA 34. Id. surprise announcement that effectively DETECTR Assay” (July 9, 2020), 35. Letter from House of Representatives precludes FDA from requiring EUAs available at https://www.fda.gov/ Select Subcommittee on the Coronavi- for laboratory developed tests (LDTs), media/139934/download. rus Crisis to Alex M. Azar II (July 14, during the COVID-19 emergency or 32. See, e.g., FDA, “EUA Letter of 2020), available at https://coronavirus. thereafter, without notice and comment Authorization—Ventilators, anes- house.gov/sites/democrats.coronavirus. rulemaking. FDA’s previously issued thesia gas machines modified for use house.gov/files/2020-07-14.Select%20 policy regarding COVID-19 testing laid as ventilators, and positive pressure Cmte.%20to%20Azar-HHS%20 out FDA’s expectation that diagnostic breathing devices modified for use Esper-DOD%20Wolf-DHS%20 (as opposed to antibody detecting) as ventilators (collectively referred Wilkie-%20VA%20re%20Adminis- LDTs would require EUAs, though to as ‘ventilators’), ventilator tubing tration%20PPE%20Contractor%20 testing could commence pursuant to en- connectors, and ventilator accessories” %281%29.pdf. forcement discretion prior to receipt of (Mar. 24, 2020), available at https:// 36. Id. an EUA so long as FDA was notified of www.fda.gov/media/136423/download; 37. Id. successful test validation, and an EUA FDA, “Emergency Use Authorization 38. Id. at 4. See also J. David McSwane request was submitted within fifteen for Novel Coronavirus (SARS-CoV-2) & Ryan Gabrielson, “The Trump days of notification. See Policy for Fast Nucleic Acid Detection Kit Administration Paid Millions for Test Coronavirus Disease-2019 Tests During (PCR-Fluorescence Probing)” (July 24, Tubes—and Got Unusable Mini Soda the Public Health Emergency (Revised) 2020), available at https://www.fda. Bottles” (June 18, 2020), available at (May 11, 2020), available at https:// gov/media/140426/download; FDA, https://www.propublica.org/article/the- www.fda.gov/media/135659/download “Emergency Use Authorization for trump-administration-paid-millions- (last visited August 27, 2020). While Helix COVID-19 Test” (July 23, 2020), for-test-tubes-and-got-unusable-mini- this announcement will make it very available at https://www.fda.gov/ soda-bottles. difficult for FDA to take enforcement media/140422/download. action against a laboratory for failing 33. DOJ, “Principal Deputy Assistant At- to seek an EUA for a COVID-19 diag- torney General Ethan P. Davis delivers nostic LDT in compliance with FDA’s remarks on the False Claims Act at the COVID-19 testing policy, false and U.S. Chamber of Commerce’s Institute misleading labeling and promotional for Legal Reform” (June 26, 2020), claims will continue to be fair game for available at https://www.justice.gov/

16 Update Fall 2020 www.fdli.org